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Stockwinners Market Radar for December 12, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
| A | Hot Stocks21:00 EST Agilent Resolution ctDx FIRST gets FDA approval as NSCLC test - Agilent Technologies "announced that the FDA has approved Agilent Resolution ctDx FIRST as a companion diagnostic to identify advanced non-small cell lung cancer, NSCLC, patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM, or adagrasib. This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. ctDx FIRST has also been approved by the FDA for tumor profiling of the epidermal growth factor receptor gene for use by qualified health care professionals in accordance with professional guidelines in oncology patients with NSCLC."
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| VERV | Hot Stocks20:03 EST Cathie Wood's ARK Investment bought 58K shares of Verve Therapeutics today
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| AMGN | Hot Stocks19:52 EST Amgen raises quarterly dividend by 10% to $2.13 - The dividend will be paid on March 8, 2023, to all stockholders of record as of the close of business on February 15, 2023.
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| NGM | Hot Stocks19:07 EST NGM Biopharmaceuticals announces presentation on NGM936 at ASH - NGM Biopharmaceuticals "provided additional detail today on the poster presentation given on the Company's first disclosed preclinical bispecific program, NGM936, at the American Society of Hematology Annual Meeting, which is taking place December 10 - 13, 2022 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. NGM936 was selected for further evaluation by NGM Bio from a panel of internally-developed ILT3 x CD3 engagers in various formats based on its ability in preclinical in vivo and in vitro studies to potently induce TDCC against ILT3+ AML cells while inducing minimal cytokine release. In those studies, NGM936 induced potent cytotoxicity comparable to a CD123 x CD3 biosimilar when both expanded and naive T cells were used as effectors. Importantly, NGM936 efficiently ablated tumor cells with a range of ILT3 expression, from ~1500 copies/cell to ~40,000 copies/cell, in those studies. In addition, as reported in the poster, NGM936 did not induce T cell-dependent cytotoxicity against CD34+ hematopoietic stem cells or non-monocytic immune cells, consistent with the lack of ILT3 expression on these cell types. In both whole blood cytokine releases assays and in TDCC assays in which cytokine secretion was measured after target engagement, induction of TNF-alpha, IL-6, IFN-gamma and IL-2 by NGM936 was considerably lower than that induced by a CD123 x CD3 biosimilar."
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| JACK | Hot Stocks19:05 EST Jack in the Box CFO Mullany to leave company for 'personal reasons' - Jack in the Box announced that Tim Mullany, Executive Vice President, and Chief Financial Officer will be leaving the company for personal reasons, effective February 2, 2023. The company has initiated a search for a new Chief Financial Officer. While the company searches to identify a successor, Dawn Hooper, VP, Controller & Financial Reporting, will assume a temporary role as Principal Financial Officer. Hooper has been with Jack in the Box Inc. for 22 years and held various leadership positions within Finance. She will report to Darin Harris, CEO, until a successor is named. Mullany joined the Jack in the Box Inc. team in January 2021 and most recently led the Del Taco acquisition. He made significant contributions over the past year in support of the Shared Services organization.
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| LIDR | Hot Stocks19:04 EST AEye names T.R. Ramachandran COO, says CEO LaCorte to resign - AEye announced the promotion of Dr. T.R. Ramachandran to the position of chief operating officer for the company. Ramachandran joined AEye in November 2021 as chief product officer. "Over the past year, T.R. has demonstrated an ability to move the company from the prototype stage to product commercialization," said Blair LaCorte, CEO of AEye. "T.R. has an innate ability and the experience to address and solve all of the issues associated with bringing a complex product to market." The company also announced today that Blair LaCorte, the CEO of AEye, has decided to transition to a more focused role for the company and informed the board of directors he will be resigning as CEO effective as of February 28, 2023. LaCorte will remain on the company's board of directors and concentrate on ensuring continuity in leadership and working to form new and enhance existing strategic partnerships between the company and its stakeholders. The company has launched a search for a successor to fill the role of CEO. Both internal and external candidates are under consideration. The search will be led by Timothy J. Dunn, the chair of the company's audit and compensation committees, and assisted by members of management, including Dussan and Greene.
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| PGEN | Hot Stocks19:03 EST Precigen announces 'positive' Phase 1 dose escalation data from PRGN-3006 study - Precigen presented positive Phase 1 dose escalation data from the ongoing Phase 1/1b clinical study of PRGN-3006 UltraCAR-T in patients with r/r AML and higher risk myelodysplastic syndromes at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentation was delivered by David A. Sallman, MD, Assistant Member in the Department of Malignant Hematology at the H. Lee Moffitt Cancer Center & Research Institute and a lead investigator for the PRGN-3006 clinical trial. PRGN-3006 UltraCAR-T is a multigenic autologous chimeric antigen receptor (CAR)-T simultaneously expressing a CAR specifically targeting CD33; membrane bound IL-15 (mbIL15) for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile. CD33 is over-expressed on AML blasts with lesser expression on normal hematopoietic stem cells. PRGN-3006 UltraCAR-T drug product is manufactured via an overnight process at medical centers using the Company's proprietary non-viral and UltraPorator(R) systems and released for infusion in patients the next day. The decentralized, overnight UltraCAR-T manufacturing process, which does not use viral vectors or ex vivo activation and expansion of T cells, has the potential to address major limitations of current T cell therapies. PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation and Fast Track Designation in patients with AML by the US Food and Drug Administration.
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| CSGP | Hot Stocks18:51 EST CoStar Group to be added to Nasdaq 100 index - CoStar Group announced that the company will be added to the Nasdaq 100 Index, effective prior to the opening of trading on Monday, December 19.
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| INM | Hot Stocks18:51 EST InMed Pharmaceuticals engages Marcum LLP as auditor after KPMG resigns - The Company "announces that its auditor, KPMG has resigned effective as of December 8, 2022, and that the Audit Committee of the Board of Directors of the Company approved the engagement of Marcum LLP as its auditor, subject to Marcum's completion of their client acceptance procedures. Marcum will stand for appointment at the Company's Annual General Meeting, currently scheduled for Thursday, December 15, 2022. KPMG has confirmed that there are no reportable events (as such term is defined in National Instrument 51-102 - Continuous Disclosure Obligations."
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| INM | Hot Stocks18:49 EST InMed Pharmaceuticals names Jonathan Tegge as interim CFO - InMed Pharmaceuticals "announces the Company has entered into a service contract with Brio Financial Group to provide senior financial leadership and bookkeeping services. Pursuant to the Contract, Mr. Jonathan Tegge, a member of Brio, will assume the role of Interim Chief Financial Officer for the Company effective December 12, 2022."
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| MRTX | Hot Stocks18:43 EST Mirati Therapeutics: FDA grants accelerated approval for KRAZATI - Mirati Therapeutics announced that the U.S. FDA has granted accelerated approval for KRAZATI, a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
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| ETNB | Hot Stocks18:37 EST 89bio announces publication of Phase 1b/2a pegozafermin study results - 89bio announced that data from cohorts 1-6 in the the Phase 1b/2a proof-of-concept study evaluating pegozafermin for the treatment of nonalcoholic steatohepatitis was published online in The Lancet Gastroenterology & Hepatology. Study results showed statistically significant absolute reductions in hepatic fat fraction at week 13 with pegozafermin administered every week or every two weeks compared to placebo. Up to 88% of patients had at least a 30% reduction in hepatic fat fraction, which has been shown to correlate with reduced fibrosis progression. Furthermore, improvements in liver transaminases, measures of fibrosis and lipids were observed with pegozafermin compared to placebo. In this study, pegozafermin was well tolerated with no treatment-related serious adverse events observed. "Patients with NASH, a complex disease, are in urgent need of disease-modifying treatments that are effective in improving their overall liver health and address key underlying metabolic issues and cardiovascular disease risk factors," said Rohit Loomba MD, MHSc, Director, NAFLD Research Center, University of California San Diego, primary investigator of the Phase 1b/2a study and lead author of The Lancet Gastroenterology & Hepatology paper. "I am very encouraged by the published study results showing pegozafermin was highly potent in reducing liver fat and was associated with clinically meaningful changes in liver health and beneficial effects on lipids and cardiovascular markers. The benefits of pegozafermin were observed across all doses and most prominently at the highest tested doses."
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| ARGO | Hot Stocks18:10 EST Argo Group confirms withdrawal of Capital Returns Master nominations - Argo Group International Holdings confirmed that Capital Returns Master, Ltd. has withdrawn its nomination of candidates Ronald Bobman and David Michelson, who Capital Returns Master previously nominated to stand for election to the Argo Board of Directors in connection with the company's 2022 Annual Meeting of Shareholders, which will be held on December 15, 2022. Argo issued the following statement: "The Argo Board and management team will continue to maintain an ongoing dialogue with its shareholders. We appreciate the constructive discussions we have had and the overwhelming support received for the Company's director nominees. Argo has a highly qualified, fully engaged and significantly refreshed Board, and we will continue to take actions to maximize value for our shareholders." Goldman Sachs & Co. LLC is serving as financial advisor to Argo and Skadden, Arps, Slate, Meagher & Flom LLP is acting as Argo's legal counsel.
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| TWTR | Hot Stocks17:54 EST Twitter debuts Blue for Business, gold checkmarks for corporate entities - In a help Center blog entry, the company said, in part. "Twitter applies visual identity signals like labels and badges on account profiles to provide more context about - and help distinguish - different types of accounts...The blue checkmark may mean two different things: either that an account was verified under Twitter's previous verification criteria (active, notable, and authentic), or that the account has an active subscription to Twitter's new Twitter Blue subscription product, which was made available on iOS on November 9...The gold checkmark indicates that the account is an official business account through Twitter Blue for Business...The Official profile label is applied to government accounts (institutional accounts, elected or appointed officials, and multilateral organizations)*, certain political organizations such as political parties, commercial companies including business partners, major brands, media outlets and publishers, and some other public figures...Candidate labels contain additional information about Twitter accounts for official national-level political candidates for some elections. The label appears on the Profile of the candidate's Twitter account and on the Tweets sent and Retweeted by the candidate's account." Reference Link
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| NRIX | Hot Stocks17:39 EST Nurix Therapeutics reports 'positive' data from Phase 1 trial of NX-2127 - Nurix Therapeutics presented additional positive clinical data from its Phase 1 clinical trial of NX-2127 in two oral sessions by Anthony Mato, M.D., MSCE, former director of the Chronic Lymphocytic Program at Memorial Sloan Kettering Cancer Center, and Omar Abdel-Wahab, M.D., Chair of Sloan Kettering Institute Molecular Pharmacology Program at Memorial Sloan Kettering Cancer Center. NX-2127 is a once daily, oral, investigational new drug that combines BTK degradation with immunomodulatory activity. The podium presentations took place at the 64th American Society of Hematology Annual Meeting and Exposition which is being held in New Orleans, Louisiana. "These early Phase 1 data demonstrate that NX-2127 effectively degrades BTK resulting in clinically meaningful responses independent of prior treatments or BTK mutational status and offering a potential new treatment modality for patients who have otherwise exhausted other approved and emerging treatment options," said Robert J. Brown, M.D., Nurix's executive vice president of clinical development. The data presented by Dr. Mato demonstrate that treatment with NX-2127 results in sustained BTK degradation and clinically meaningful responses in heavily pretreated patients with relapsed/refractory CLL independent of prior treatments or BTK mutational status. These presentations included preliminary data from 36 adults with relapsed/refractory B-cell malignancies enrolled in the Phase 1a/b study, including 23 patients with CLL who had undergone and failed a median of five prior therapies including a BTK inhibitor. Approximately 78% of this group had previously received both BTK and BCL2 inhibitors and 35% had been treated with the non-covalent BTK inhibitor pirtobrutinib. Of the CLL patients, 48% had one or more identified BTK resistance mutations prior to treatment with NX-2127. Following treatment with NX-2127 in this heavily pretreated CLL population, sustained BTK degradation and decreased B cell activation were observed regardless of prior treatment and baseline BTK mutation status with an overall response rate of 33%. As of September 21, 2022, the data cut-off date, the median follow up was 5.6 months, and 14 of 23 patients remained on treatment. Importantly, the safety profile of NX-2127 was consistent with prior results from the Phase 1a portion of the trial and reports for BTK-targeted therapies in heavily pretreated patients with B cell malignancies. The presentation by Dr. Abdel-Wahab highlighted critical scientific findings underlying the emergence of new BTK inhibitor resistance mutations that lack BTK's enzymatic function but still drive tumor growth. These so-call "kinase deficient" and "kinase dead" mutations underscore the importance of BTK's scaffolding function, which is uniquely addressable by the BTK degrader modality. In the presentation, five different clinically emergent BTK resistance mutations were analyzed and categorized as kinase proficient, kinase deficient, or kinase dead, each conferring a different spectrum of resistance to available therapies. NX-2127 was found to be broadly active against all these mutations. These findings translated into clinically meaningful BTK degradation in the Phase clinical 1 trial and clinical activity independent of baseline BTK mutations.
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| COTY | Hot Stocks17:38 EST Coty expands buyback program by $200M - Coty "announced it is entering into agreements with several banks to start hedging a planned share buyback program of approximately $200M in calendar 2025. This program adds to the Company's previously announced $200M hedged buyback in 2024. Coty anticipates continued strong free cash flow generation and steady deleveraging progress in the coming years, continuing to target leverage towards 4x exiting 2022, towards 3x exiting 2023, and towards 2x 2025."
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| LLY | Hot Stocks17:37 EST Eli Lilly oncology unit announces updated data from BRUIN trial - Loxo@Lilly, the oncology unit of Eli Lilly and Company announced updated clinical data from the pirtobrutinib global Phase 1/2 BRUIN trial in patients with chronic lymphocytic leukemia, or CLL, small lymphocytic lymphoma, or SLL, mantle cell lymphoma, or MCL, Richter transformation, or RT, and Waldenstrom macroglobulinemia, or WM. Pirtobrutinib is an investigational, highly selective, reversible inhibitor of Bruton's tyrosine kinase, or BTK. These data are featured in oral and poster presentations at the 2022 American Society of Hematology, or ASH, annual meeting. The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib monotherapy in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas, or NHL. The efficacy data being presented at ASH for MCL and CLL/SLL are based on independent review committee, or IRC, assessment while the efficacy data for RT and WM are based on investigator response assessments. The safety cohort consisted of all patients with B-cell malignancies who received at least one dose of pirtobrutinib monotherapy as of the data cutoff date. The BRUIN trial includes one of the largest prospective cohorts of BTK inhibitor pre-treated CLL/SLL patients ever studied. As of the July 29, 2022 data cutoff date, 247 patients with CLL/SLL had received a prior BTK inhibitor and enrolled prior to November 5, 2021, to ensure adequate follow-up. Patients had received a median of three prior therapies. In this dataset, pirtobrutinib demonstrated an overall response rate of 82% and median progression-free survival of 19.6 months. In patients treated with both a prior BTK and BCL2 inhibitor, the ORR was 79%, and median PFS was 16.8 months. Response rates were consistent across all subgroups analyzed regardless of mutation status, age, or previous therapies. As of the January 31, 2022 data cutoff date, the primary analysis set consisted of the first 90 patients enrolled with MCL who had received a prior BTK inhibitor. Patients had received a median of three prior lines of therapy. In this dataset, pirtobrutinib demonstrated an ORR of 58%, a median duration of response of 21.6 months and a median PFS of 7.4 months. Response rates were consistent regardless of number of prior lines of therapy and classes of prior therapy received. The BRUIN trial also includes one of the largest prospective RT populations ever studied. As of the July 29 data cutoff date, 75 patients with RT were response evaluable, with 68 patients having received prior treatment for RT. Among these patients, the median number of prior lines of CLL therapy was two and the median number of prior lines of RT therapy was two. The ORR for the 75 response-evaluable patients was 52% and for the 68 patients previously treated for RT, the ORR was 50%. Among all response evaluable patients, median overall survival, or OS, was 13.1 months and DoR was 5.6 months, regardless of prior RT therapy. As of the July 29 data cutoff date, 80 patients with WM were response evaluable, with 63 patients having received prior treatment with a BTK inhibitor. Among the 63 patients, the median number of prior therapies was three. The major response rate was 67%, including 15 very good partial responses and 27 partial responses. In patients who previously received both chemoimmunotherapy and a covalent BTK inhibitor, the MRR was 68%. Median PFS was 19.4 months in patients who received previous treatment with a covalent BTK inhibitor. In the safety cohort of all pirtobrutinib-treated patients, the most frequent treatment-emergent adverse events, regardless of attribution, were fatigue, diarrhea and contusion. The most frequent Grade 3 TEAE was neutropenia. Low rates of Grade 3 TEAEs of hypertension, hemorrhage and atrial fibrillation/flutter were observed. Overall, discontinuations due to a treatment-related adverse event occurred in 3% of all patients. The safety profile was generally consistent across the populations studied. The safety and tolerability of pirtobrutinib monotherapy in patients with relapsed or refractory B-cell malignancies who were intolerant to a prior covalent BTK inhibitor was evaluated. Atrial fibrillation was among the most common adverse events that led to the discontinuation of a prior covalent BTK inhibitor, and in these patients, this AE recurred with pirtobrutinib treatment in two patients. Most patients did not experience high-grade recurrence of the other common AEs that led to discontinuation of a prior covalent BTK inhibitor, with the exception of neutropenia. No patient who discontinued a prior BTK inhibitor due to an AE had to discontinue pirtobrutinib for the same AE.
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| REGN | Hot Stocks17:37 EST Regeneron announces data on trial of odronextamab to treat R/R FL - Regeneron Pharmaceuticals announced positive first data from a cohort of a pivotal Phase 2 trial evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory R/R follicular lymphoma grades 1 to 3a. The data were presented in an oral session at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, LA, and follow the first Phase 2 results for odronextamab in R/R diffuse large B-cell lymphoma DLBCL from the same trial that were presented yesterday. The results will form the basis of planned submissions to regulatory authorities in 2023, including to the U.S. Food and Drug Administration . Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing."There is high unmet need for follicular lymphoma treatments that can improve tumor control and extend survival, given that there is no cure for this cancer and patients will experience multiple relapses," said Tae Min Kim, M.D., Ph.D., Department of Internal Medicine, Seoul National University Hospital in Seoul, South Korea, and a trial investigator. "These positive pivotal Phase 2 results investigating odronextamab in heavily pre-treated, relapsed/refractory follicular lymphoma patients showed deep and durable response - confirming earlier findings in this program - with the highest complete response rates seen in this patient population to date. We look forward to seeing the data continue to mature."
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| HUT | Hot Stocks17:24 EST Hut 8 Mining names Shenif Visram as CFO, succeeding Shane Downey - Hut 8 Mining is pleased to announce the appointment of Shenif Visram, CPA, CMA as the company's CFO, effective immediately. With more than 20 years of financial management experience in the infrastructure and technology businesses, Shenif brings a wealth of leadership expertise working in medium and large public and private companies. Shenif, who will be based in Toronto and will report to CEO Jaime Leverton, is replacing Hut 8's CFO Shane Downey, who is moving on to pursue new opportunities after 20 months with the organization.
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| MBC CONN | Hot Stocks17:21 EST MasterBrand to replace Conn's in S&P 600 at open on 12/19
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| FBIN FSLR | Hot Stocks17:20 EST Fortune Brands Innovations to replace First Solar in S&P 400 at open on 12/19
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| FSLR FBHS | Hot Stocks17:19 EST First Solar to replace Fortune Brands in S&P 500 at open on 12/19 - Fortune Brands Home & Security (FBHS) is spinning off MasterBrand in a transaction expected to be completed December 15. Post spin-off, Fortune Brands Home & Security will have a name and symbol change to Fortune Brands Innovations (FBIN) and will be more representative of the midcap market space.
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| ATR | Hot Stocks17:09 EST AptarGroup to realign two of its business reporting segments - AptarGroup announced that it will realign two of its business reporting segments effective January 1, 2023. Aptar's two renamed reporting segments will be Aptar Closures and Aptar Beauty. The new segment structure is designed to streamline operations, improve efficiencies and enable a stronger customer focus across all closure applications. Aptar Closures will focus specifically on leveraging the closures platform with an aim of broadening the markets that Aptar serves with these technologies. Combining Aptar's closures activities into one segment will allow the Company to better serve customers by concentrating its closures product design, marketing and manufacturing expertise. Additionally, the emphasis on closures within one segment will help to streamline operations and better leverage these capabilities. The realignment will also focus and simplify Aptar Beauty and strengthen the company's competitive position. Aptar Beauty will develop and provide complex spray and dispensing solutions for the fragrance, cosmetics, skincare and personal care markets. The segment will also supply home care, food and beverage customers that use spray or pump dispensing technologies. Aptar will continue to have three reporting segments: Aptar Pharma, Aptar Beauty and Aptar Closures. Aptar will disclose the recast historical financials of the new segments before its first quarter 2023 results.
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| ATR | Hot Stocks17:06 EST AptarGroup to two of its business reporting segments effective January 1, 2023 - AptarGroup announced that it will realign two of its business reporting segments effective January 1, 2023. Aptar's two renamed reporting segments will be Aptar Closures and Aptar Beauty. The new segment structure is designed to streamline operations, improve efficiencies and enable a stronger customer focus across all closure applications. Aptar Closures will focus specifically on leveraging the closures platform with an aim of broadening the markets that Aptar serves with these technologies. Combining Aptar's closures activities into one segment will allow the Company to better serve customers by concentrating its closures product design, marketing and manufacturing expertise. Additionally, the emphasis on closures within one segment will help to streamline operations and better leverage these capabilities. The realignment will also focus and simplify Aptar Beauty and strengthen the company's competitive position. Aptar Beauty will develop and provide complex spray and dispensing solutions for the fragrance, cosmetics, skincare and personal care markets. The segment will also supply home care, food and beverage customers that use spray or pump dispensing technologies. Aptar will continue to have three reporting segments: Aptar Pharma, Aptar Beauty and Aptar Closures. Aptar will disclose the recast historical financials of the new segments before its first quarter 2023 results.
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| QDEL | Hot Stocks16:55 EST QuidelOrtho announces separation of Chairman, CEO roles - QuidelOrtho announced that its Board of Directors has appointed Dr. Kenneth Buechler, Lead Independent Director, to non-executive Chairman, effective December 11, 2022. The separation of the Chairman and CEO roles is a key step toward strengthening the company's governance practices and will facilitate the right balance between strong and consistent company leadership and independent oversight by the Board. The Board also appointed Douglas Bryant to serve as President, in addition to Bryant's current role as CEO and a member of the Board.
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| WBEV | Hot Stocks16:54 EST Winc Inc trading halted, news pending
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| HRI | Hot Stocks16:51 EST Herc Holdings CFO Irion sells 4,194 common shares - In a regulatory filing, Herc Holdings CFO Mark Irion disclosed the sale of 4,194 common shares of the company on December 9 at a price of $131.37 per share.
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| FANG | Hot Stocks16:45 EST Diamondback Energy added to Nasdaq-100 Index - Diamondback Energy announced that it has been added to the Nasdaq-100 Index, the top 100 largest domestic and international non-financial companies on The Nasdaq based on market capitalization. Nasdaq announced the inclusion on Friday, December 9, which will become effective prior to market open on Monday, December 19.
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| RTX | Hot Stocks16:44 EST Raytheon Technologies board authorizes $6B share buyback - Raytheon Technologies' Board of Directors authorized the repurchase of up to $6B of the company's outstanding common stock. The new authorization replaces the company's previous program, approved Dec. 7, 2021. Share repurchases may take place from time to time, subject to market conditions and at the company's discretion, in the open market, through privately negotiated transactions or other means.
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| PLL | Hot Stocks16:37 EST Piedmont Lithium announces North American Lithium to restart mining operations - Piedmont Lithium announced that North American Lithium, an open pit mining and spodumene concentrate operation owned 75% by Sayona Mining and 25% by Piedmont, was issued the last remaining permit required to restart operations at the Quebec site. Receipt of the key permit from Canada's Department of Fisheries and Oceans paves the way for an expected restart of spodumene concentrate production in H1 2023.
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| QTNT | Hot Stocks16:35 EST Quotient trading resumes
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| BTCM | Hot Stocks16:34 EST BIT Mining Limited plans to implement ADS ratio change - BIT Mining Limited announced that it plans to change the ratio of its American Depositary Shares to its Class A ordinary shares, par value $0.00005 per share, from the current ADS Ratio of one ADS to ten Class A ordinary shares, to a new ADS Ratio of one ADS to one hundred Class A ordinary shares. The company anticipates that the ADS Ratio Change will be effective on or about December 23, 2022. For BIT Mining's ADS holders, the ADS Ratio Change will have the same effect as a one-for-ten reverse share split. BIT Mining's ADSs will continue to be traded on the New York Stock Exchange under the ticker symbol "BTCM". No fractional new ADSs will be issued in connection with the ADS Ratio Change. The ADS Ratio Change will have no impact on BIT Mining's underlying Class A ordinary shares, and no Class A ordinary shares will be issued or cancelled in connection with the ADS Ratio Change. As a result of the ADS Ratio Change, BIT Mining's ADS trading price is expected to increase proportionally; however, there can be no assurance that the ADS trading price after the ADS Ratio Change will be equal to or greater than ten times the ADS trading price before the change.
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| MGTA | Hot Stocks16:32 EST Magenta Therapeutics presents positive MGTA-117 clinical data at ASH - Magenta Therapeutics "highlights updated clinical data from the ongoing MGTA-117 Phase 1/2 dose-escalation clinical trial made in an oral presentation today at the American Society of Hematology 2022 Annual Meeting in New Orleans and provides program updates across the portfolio. "We have shown that a single dose of MGTA-117 binds target cells, depletes target cells, clears the body quickly as designed, and does so with a favorable tolerability profile in our ongoing Phase 1/2 clinical trial. We believe that these positive clinical data establishes proof-of-mechanism, and that we have reached an active dose. Target cell depletion is a critical measurement of success for MGTA-117, and we are encouraged by the levels of depletion we have observed in both the blood and the bone marrow of relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome patients. We are excited about our planned next steps to take MGTA-117 into transplant-eligible AML and MDS patients as well as into patients who are receiving gene therapy. We are thankful to all of the patients and families who have participated in our trial to date as well as our investigators and the clinical site staff, all of whom have contributed greatly to the advancement of MGTA-117 for patients," said Jason Gardner, President and CEO of Magenta Therapeutics. "Together with the progress we are making on CD45-ADC and MGTA-145, we are pleased with the momentum across our portfolio and the multiple anticipated inflection points for Magenta in the coming year."
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| BHG | Hot Stocks16:31 EST Bright Health receives continued listing standard notice from NYSE - Bright Health Group announced that on December 6, 2022, the Company received a written notice from the New York Stock Exchange that it was not in compliance with the continued listing standard set forth in Section 802.01C of the NYSE's Listed Company Manual, as the average closing price of the Company's common stock was less than $1.00 per share over a consecutive 30 trading-day period ending December 2, 2022. During the cure period, the Company's common stock will continue to trade on the NYSE, subject to the Company's compliance with the NYSE's other continued listing requirements. The notice does not affect the Company's ongoing business operations or its U.S. Securities and Exchange Commission reporting requirements, nor does it cause an event of default under any of the Company's debt obligations. The Company has responded to the NYSE with respect to its intent to cure the deficiency. The Company intends to consider available alternatives, including, but not limited to, a reverse stock split, subject to stockholder approval no later than at the Company's next annual meeting of stockholders, if necessary, to regain compliance. The Company has a period of six months following the receipt of the notice to regain compliance with the minimum share price requirement. Section 802.01C also provides for an exception to the six-month cure period if the action required to cure the price condition requires stockholder approval, in which case, the action needs to be approved by no later than the Company's next annual stockholder's meeting.
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| DEN WY | Hot Stocks16:31 EST Denbury, Weyerhaeuser sign pact for CO2 sequestration site in Mississippi - Denbury (DEN) and Weyerhaeuser (WY) announced an agreement for the evaluation and potential development of a CO2 sequestration site in Mississippi. The lease agreement provides Denbury with the exclusive right to develop and operate approximately 16,000 acres of subsurface pore space owned by Weyerhaeuser in Simpson and Copiah Counties in Mississippi. The site is located directly adjacent to Denbury's NEJD Pipeline in Mississippi, approximately 35 miles south of the company's Jackson Dome field. Denbury is planning to utilize the site to permanently sequester industrial CO2 in secure underground geologic formations. Weyerhaeuser will continue to manage the timberland acreage as a sustainable working forest. Denbury estimates the site will have total sequestration capacity of approximately 275 million metric tons of CO2. The site represents Denbury's first planned CO2 sequestration location in Mississippi, expanding its storage portfolio that already includes sites along the U.S. Gulf Coast in Alabama, Louisiana, and Texas. Denbury intends to drill a stratigraphic test well on the site in 2023 to support the Company's geologic interpretation and progress Class VI permitting with the EPA.
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| PLNT | Hot Stocks16:30 EST Planet Fitness names Edward Hymes president, COO - Planet Fitness announced that Edward Hymes has been appointed President and Chief Operating Officer reporting directly to Chief Executive Officer, Chris Rondeau. Mr. Hymes will join the brand in January and be responsible for driving both the day-to-day business and longer-term strategic growth of the Company, with overall leadership and accountability of the brand's primary revenue producing business segments, including U.S. and international franchise operations and development, equipment sales, and Corporate stores, in addition to both the technology and legal functions. "Edward is a seasoned executive with over 30 years of experience including identifying, developing, and operating domestic and international retail and e-commerce businesses for global companies," said Chris Rondeau, Chief Executive Officer. "We believe his skillset and franchise leadership will be instrumental in helping to strategically accelerate our business growth through existing and new channels, and we are thrilled to welcome him to our executive team."
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| ATAK | Hot Stocks16:30 EST Aurora Technology Acquisition Corp trading resumes
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| CSV | Hot Stocks16:24 EST Carriage Services launches operating and financial plan for 2023 and 2024 - "Our fourth quarter 2022 performance is trending stronger than expected against a tough record comparable performance last year. Our guidance plan is to issue our customary Full Year Outlook for 2023 when we report full year 2022 performance results at the end of February 2023, when we should have a much clearer picture of a post-COVID normalized deathrate environment and its near-term impact on our performance, especially compared to our record first quarter 2022 performance. Given no near-term guidance in our third quarter release combined with a weak comparative third quarter 2022 performance and an elevated leverage ratio of 5.14 times Total Debt to Consolidated EBITDA, investors seemed to believe bad news would follow by selling our shares in volume with the result that our share price plummeted to below $25 per share. Finding this external high-risk perception of our company inexcusable and unacceptable, we went to work with Bank of America and our credit facility bank group on a comprehensive plan of both offensive and defensive actions .I am pleased to announce on behalf of our Executive Team and Board of Directors that we have developed, organized and launched an operating and financial plan for 2023 and 2024 titled High Performance and Credit Profile Restoration Plan HPCPRP," said the company in a statement.
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| PNR | Hot Stocks16:21 EST Pentair raises quarterly dividend 5% to 22c per share - Dividend is payable on February 3, 2023 to shareholders of record at the close of business on January 20, 2023.
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| AB | Hot Stocks16:20 EST AllianceBernstein reports preliminary AUM $658B as of November 30 - Up from $627B at the end of October. The 5% AUM increase was driven by market appreciation, partially offset by firm-wide net outflows. By channel, Retail and Institutions posted net outflows while Private Wealth was slightly positive.
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| IVZ | Hot Stocks16:18 EST Invesco reports preliminary AUM $1.43T as of November 30 - Invesco reported preliminary month-end assets under management of $1.4379T, an increase of 5.7% versus previous month-end. The firm experienced net long-term inflows of $1.3B in the month.
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| TRMB | Hot Stocks16:17 EST Trimble to acquire Transporeon for EUR 1.88B in cash - Trimble announced that it has agreed to acquire Transporeon, a leading cloud-based transportation management software platform, in an all-cash transaction valued at EUR 1.88B. Transporeon's software platform provides modular applications that power a global network for 145,000 carriers and 1,400 shippers and load recipients with an integrated suite of best-in-class sourcing, planning, execution, monitoring and settlement tools. Trimble will acquire Transporeon from Hg, a leading software and services investor and current majority shareholder in the business. Transporeon's open platform integrates with more than 3,000 global ERP and transportation management systems, enabling a dense network to facilitate more than 25 million on-platform transports in 2022. Transporeon helps customers increase competitiveness, lower costs, reduce waste and solve complex freight problems through automation, real-time insights and network participation. Transporeon operates predominantly in Europe, as well as in developed markets across the Americas and Asia. Consistent with its cloud software model, Transporeon has a strong financial profile with recurring revenue representing over 90% of total revenue, with extremely low churn and net retention consistently in excess of 110%. Transporeon will be immediately accretive to Trimble's revenue growth and margin profile, and has generated profitable growth over the past 15 plus years, through various stages of the economic cycle. The transaction is expected to close in the first half of 2023, subject to customary closing conditions including regulatory approvals.
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| BWMN | Hot Stocks16:16 EST Bowman Consulting awarded $5M transportation services contract from PDOT - Bowman Consulting Group announced that the Pennsylvania Department of Transportation District 6-0 has awarded the firm a $5M, 5-year open end contract for design services on the PA Route 100 at Exton Station project in West Whiteland Township, PA. The contract was awarded through the Company's wholly owned McMahon subsidiary. Services to be provided under the contract include all preliminary and final transportation engineering and design activities, and construction consultation, which involves project management, administration and meetings, roadway plans, preliminary traffic control and signal design, survey, safety review and utility/railroad coordination. The anticipated improvements on the PA 100 approach to Exton will include four distinct elements: (1) addition of a northbound lane from Pottstown Pike through the intersection with US 30 Bypass ramps; (2) shifting the existing travel lanes and the center median to accommodate an additional through-lane under the Amtrak/SEPTA and Norfolk Southern railroad overpasses; (3) modifications to Mountain View Drive intersection; (4) modifications to the Whiteland Woods Boulevard intersection.
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| ORCL | Hot Stocks16:15 EST Oracle reports Q2 total cloud revenue $3.8B, up 43% in USD, up 48% in CC - Reports Q2: Cloud Infrastructure (IaaS) Revenue $1.0 billion, up 53% in USD, up 59% in constant currency; Q2 Cloud Application (SaaS) Revenue $2.8 billion, up 40% in USD, up 45% in constant currency; Q2 Fusion Cloud ERP (SaaS) Revenue $0.6 billion, up 23% in USD, up 28% in constant currency; Q2 NetSuite Cloud ERP (SaaS) Revenue $0.6 billion, up 25% in USD, up 29% in constant currency.
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| RKLY | Hot Stocks16:15 EST Rockley Photonics names Richard Meier CEO - Rockley Photonics Holdings Limited announced changes to its senior management team. These changes are intended to position the company for its next phase of growth. Effective immediately, Richard A. Meier has been appointed president and chief executive officer, and will join the board of directors. Dr. Andrew Rickman has resigned as chief executive officer and will take on the role of executive chairman of Rockley. Chad Becker will assume the role of interim chief financial officer. The company also announced that Dr. Caroline Brown is stepping down from the board to pursue other business interests. Dr. Brown served as chair of the audit committee of the board and a member of the nominating and corporate governance committee. The board has appointed Dr. Nicolaus Henke to the audit committee to fill the vacancy resulting from Dr. Brown's departure. Brian Blaser will serve as the chair of the audit committee.
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| ORCL | Hot Stocks16:14 EST reports Q2 total cloud revenue $3.8B, up 43% in USD, up 48% in CC - Reports Q2: Cloud Infrastructure (IaaS) Revenue $1.0 billion, up 53% in USD, up 59% in constant currency; Q2 Cloud Application (SaaS) Revenue $2.8 billion, up 40% in USD, up 45% in constant currency; Q2 Fusion Cloud ERP (SaaS) Revenue $0.6 billion, up 23% in USD, up 28% in constant currency; Q2 NetSuite Cloud ERP (SaaS) Revenue $0.6 billion, up 25% in USD, up 29% in constant currency.
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| ORCL | Hot Stocks16:12 EST Oracle says strengthening of the U.S. dollar had 'significant' impact on Q2 - The strengthening of the U.S. dollar compared to foreign currencies had a significant impact on results in the quarter. Without the impact of the U.S. dollar strengthening compared to foreign currencies, Oracle's reported Q2 non-GAAP earnings per share would have been 9c higher.
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| NYT | Hot Stocks16:11 EST New York Times CFO Roland Caputo to retire - The New York Times Company "announced that Roland A. Caputo, executive vice president and chief financial officer, plans to retire next year. He will continue to serve as C.F.O. until his successor is identified, and is expected to stay on through a transition period."
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| IKT | Hot Stocks16:10 EST Inhibikase Therapeutics doses first subjects in IkT-001Pro study - Inhibikase Therapeutics announced the dosing of the first three subjects in its '501' bioequivalence study of IkT-001Pro, the company's prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib. IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and will enroll approximately 56 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses. The study is designed to evaluate the safety profile of IkT-001Pro as well as identify a dose that mimics the systemic exposure and pharmacokinetics of 400 mg imatinib mesylate, the standard-of-care dose for Stable-Phase CML. Following this study, Inhibikase plans to conduct a superiority study comparing the selected dose of IkT-001Pro to 400 mg imatinib mesylate and evaluate the adverse event profile and patient reported outcomes as a measure of superiority over standard-of-care.
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| ORCL | Hot Stocks16:09 EST Oracle reports Q2 Q2 total cloud revenue $3.8B, up 43% in USD, up 48% in CC - Reports Q2: Cloud Infrastructure (IaaS) Revenue $1.0 billion, up 53% in USD, up 59% in constant currency; Q2 Cloud Application (SaaS) Revenue $2.8 billion, up 40% in USD, up 45% in constant currency; Q2 Fusion Cloud ERP (SaaS) Revenue $0.6 billion, up 23% in USD, up 28% in constant currency; Q2 NetSuite Cloud ERP (SaaS) Revenue $0.6 billion, up 25% in USD, up 29% in constant currency.
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| EAR | Hot Stocks16:07 EST Eargo to partner with NationsBenefits on over-the-counter hearing aids - NationsBenefits and Eargo announced a strategic partnership. The partnership will allow health plan members served by NationsBenefits to use their plan benefit towards purchasing Eargo Over-the-Counter hearing aids starting on January 1, 2023.
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| ORCL | Hot Stocks16:07 EST Oracle CEO: Q2 'powered by our infrastructure and applications cloud business' - "In Q2, Oracle's total revenue grew 25% in constant currency-exceeding the high end of our guidance by more than $200 million," said Oracle CEO, Safra Catz. "That strong overall revenue growth was powered by our infrastructure and applications cloud businesses that grew 59% and 45% respectively, in constant currency. Fusion Cloud ERP grew 28% in constant currency, NetSuite Cloud ERP grew 29% in constant currency-each and every one of our strategic businesses delivered solid revenue growth in the quarter." "Since the acquisition, Cerner has contributed to Oracle's growth-and Oracle has helped Cerner improve its technology," said Oracle Chairman and CTO, Larry Ellison. "But we are just beginning our mission to modernize healthcare information systems. In the wake of the COVID pandemic, there is a worldwide sense of urgency to transform and improve national healthcare systems. Our goals are ambitious: fully automate clinical trials to shorten the time it takes to deliver lifesaving new drugs to patients, enable doctors to easily access better information leading to better patient outcomes, and provide public health professionals with an early warning system that locates and identifies new pathogens in time to prevent the next pandemic. The scale of this opportunity is unprecedented-and so is the responsibility that goes along with it."
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| QTNT | Hot Stocks16:07 EST Quotient to delist shares from Nasdaq - Quotient announced that it has given formal notice to Nasdaq of its intention to voluntarily delist its ordinary shares from Nasdaq. In order to implement the delisting, the company intends to file a Form 25 with the Securities and Exchange Commission on or about December 27. The delisting of the company's ordinary shares will take effect no earlier than ten days after the date of that Form 25 filing. The company expects that as a result of this voluntary delisting, the last trading day of its ordinary shares on Nasdaq will be on or about January 6, 2023. The company expects that in connection with the transactions referred to below, it will seek to suspend its reporting obligations under the Securities Exchange Act of 1934. The company does not intend to apply to list its ordinary shares on any other stock exchange or for quotation of its ordinary shares in any quotation medium.
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| ORCL | Hot Stocks16:06 EST Oracle reports Q2 total cloud revenue $3.8B, up 18% in USD, up 25% in CC - Reports Q2: Cloud Infrastructure (IaaS) Revenue $1.0 billion, up 53% in USD, up 59% in constant currency; Q2 Cloud Application (SaaS) Revenue $2.8 billion, up 40% in USD, up 45% in constant currency; Q2 Fusion Cloud ERP (SaaS) Revenue $0.6 billion, up 23% in USD, up 28% in constant currency; Q2 NetSuite Cloud ERP (SaaS) Revenue $0.6 billion, up 25% in USD, up 29% in constant currency.
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| BGSF | Hot Stocks16:05 EST BGSF acquires Horn Solutions, terms not disclosed - BGSF announced that it has acquired Horn Solutions, a Texas-based workforce solutions firm specializing in business consulting, managed services, and executive search. Horn, with offices in Houston, Dallas and Austin, Texas, is well-known for understanding business, listening to needs of its clients and supplying the right professionals, including bench and contract resources, that deliver results. Horn's areas of focus include Strategic Finance & Accounting, Transactional Accounting & Business Administration, and Information Technology. Horn also offers support services in consulting, loan staff for projects, interim and staff augmentation, direct hire and managed services. Its predecessor was founded in 1987 and re-named Horn Solutions in 2008. Horn reported unaudited revenues of approximately $30 million for the trailing twelve months ending September 2022.
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| HLLY | Hot Stocks16:03 EST Holley names Jesse Weaver CFO - Holley announced the appointment of Jesse Weaver as the company's Chief Financial Officer. Weaver will succeed Stephen Trussell, who has served as the company's Interim Chief Financial Officer since September 30, 2022. Trussell will continue as the company's Vice President of Finance, a role he has held since 2009.
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| ATAK | Hot Stocks16:02 EST Aurora Technology Acquisition, DIH Technology sign LOI for combination - Aurora Technology Acquisition Corp. and DIH Technology announced the signing of a non-binding Letter of Intent for a potential business combination. Under the terms of the LOI, ATAK and DIH would become a combined entity, with DIH's shareholders rolling 100% of their equity into the combined public company. ATAK and DIH expect to announce additional details regarding the business combination when a definitive agreement is executed, which is expected before January 31, 2023.
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| QTNT | Hot Stocks16:00 EST Quotient trading halted, news pending
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| ATAK | Hot Stocks16:00 EST Aurora Technology Acquisition Corp trading halted, news pending
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| LLY | Hot Stocks15:27 EST Eli Lilly increases dividend 15% to $1.13 per share - The board of directors of Eli Lilly and Company announced a 15% increase in its quarterly dividend and declared a dividend for the first quarter of 2023 of $1.13 per share on outstanding common stock. The dividend is payable on March 10, 2023 to shareholders of record at the close of business on Feb. 15, 2023.
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| FSR | Hot Stocks15:17 EST Fifth Delta reports 8.71% stake in Fisker - A Schedule 13G was jointly filed with the SEC by Fifth Delta, a private limited company organized under the laws of England and Wales, and Fifth Delta Master Fund Limited, an exempted company incorporated in the Cayman Islands with limited liability with respect to the ownership of Class A Common Stock of the Fisker by the Master Fund. Fifth Delta and the fund own 15,631,450 common shares, or 8.71% percent of the class of stock.
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| LSPR | Hot Stocks15:12 EST Larkspur Health Acquisition Corp trading resumes
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| LSPR | Hot Stocks15:02 EST Larkspur Health Acquisition Corp trading halted, volatility trading pause
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| ATA RLLY | Hot Stocks14:51 EST Americas Technology Acquisition, Rally Communitas terminate merger agreement - Americas Technology Acquisition Corp. announced late on Friday that ATA and Rally Communitas, a Mass Mobility as a Service company, have mutually agreed to terminate the previously announced agreement and plan of merger between ATA and Rally. Termination of the merger agreement has been approved by the board of directors of both ATA and Rally.
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| NBST | Hot Stocks14:06 EST Infinite Reality to go public via combination with Newbury Street Acquisition - Infinite Reality, which calls itself "the leader in delivering immersive virtual experiences," and Newbury Street Acquisition Corporation (NBST), a special purpose acquisition company, announced they have entered into a definitive business combination agreement. Upon completion of the proposed business combination, NBST will change its name to Infinite Reality, Inc., and the combined company's common stock, warrants and units are expected to be listed on the Nasdaq Stock Market. The proposed business combination is expected to provide up to $128M growth capital to Infinite Reality and is conditioned on minimum cash of $50M at closing. After payment of transaction expenses, the net proceeds will be used to continue to build out infrastructure, expand teams in Europe, Asia, and the United States, accelerate marketing of iR's products and services with a focus on sports and entertainment, music, broadcast, and brands, and to finance future acquisitions. In connection with the transaction, non-redeeming NBST stockholders and investors that subscribe for shares in a private placement to be consummated concurrent with the business combination will receive CVRs entitling holders to certain down-side price protection and a premium return, subject to trading prices of Pubco common stock during the 18-month period after the closing. The parties expect the transaction to be consummated during the first quarter of 2023. "We're thrilled to announce this business combination and pathway for Infinite Reality to enter the public market. We continue to empower brands to upend the traditional, static one-way viewership of events and online retail experiences. We're offering the next iteration of the internet with infinite potential for brands to connect with new audiences and deepen relationships with their committed fans by offering unique, engaging, and personalized social experiences, all while creating new opportunities for commercial monetization," said Infinite Reality CEO John Acunto.
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| NSRGY | Hot Stocks13:56 EST Fonterra and Nestle agree to sale of DPA Brazil joint venture - Fonterra and Nestle announced that they agreed to the sale of their Dairy Partners Americas, or DPA, Brazil joint venture to French dairy company Lactalis for BRL 700M, or approximately NZD$210M, subject to closing transaction adjustments. The deal is expected to be completed by mid-2023, subject to regulatory authority approvals. Reference Link
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| NLTX | Hot Stocks13:35 EST Neoleukin Therapeutics presents preclinical data on NEO-TRA1 at ASH - Neoleukin Therapeutics presented data on NEO-TRA1, a precision-tuned agonist of the IL-2 receptor beta and gamma subunits that is targeted to and selectively expands inhibitory T-regulatory cells. The data was disclosed on Monday as an oral presentation at the American Society of Hematology Annual Meeting. The presentation highlights two important features of Neoleukin's de novo protein technology: the ability to target de novo cytokine mimetics to specific cell types, i.e. T-regulatory cells; and precision-tuned de novo payloads that have minimal effects on non-targeted cells. By separating the targeting domain from the cytokine receptor agonist, Neoleukin scientists have created a potentially modular system for the cis-targeting of de novo proteins to specific immune cell subsets. In preclinical models, potent and selective expansion of Treg cells was demonstrated in vitro in human cells from healthy donors and from patients with systemic lupus erythematosus as well as in vivo in humanized mouse models.
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| PFE | Hot Stocks13:29 EST Pfizer sees revenue potential of mRNA vaccines $10B-$15B annually by 2030
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| PFE | Hot Stocks13:28 EST Pfizer sees $1B-$2B of potential annual revenue from UC drug Etrasimod - Sees potential worldwide revenues of more than $6B from migraine drug portfolio. Sees potential revenues of over $2B from the company's RSV vaccine candidate. Comments taken from slides being presented at the company's pipeline day.
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| CNSWF | Hot Stocks13:25 EST Constellation Software to acquire WideOrbit, plans Lumine spin out - Constellation Software and its subsidiary Lumine Group announced that they have entered into a binding agreement and plan of merger with WideOrbit Inc., a U.S.-based media vertical market software provider. Once the transaction is completed, WideOrbit will become a wholly owned subsidiary within Lumine Group and will operate as an autonomous business unit within the Lumine Group's portfolio of companies. In addition, Constellation announced that a preliminary prospectus has been filed in all provinces and territories of Canada in connection with the proposed distribution of the shares of Lumine Group Inc., which entity is expected to be spun out of Constellation and will operate as a separate publicly traded company. Under the proposed transaction structure, Constellation will remain the majority shareholder of Lumine Group and will distribute to the current Constellation shareholders, pro rata and by way of a dividend-in-kind, nominal value subordinate voting shares of Lumine Group. A record date for the distribution of the dividend-in-kind will be set at a later date. The spin out and listing are subject to the approval of the TSX Venture Exchange and acceptance of a final prospectus by the Canadian securities regulatory authorities.
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| WASH | Hot Stocks13:24 EST Washington Trust announces 2023 buyback program up to 5% of shares - Washington Trust Bancorp announced that its board adopted a stock repurchase program, which authorizes the repurchase of up to 850,000 shares, or approximately 5%, of its common stock. The 2023 stock repurchase program commences on January 1, 2023 and expires on December 31, 2023 and may be modified, suspended, or discontinued at any time. Washington Trust had approximately 17.2M shares outstanding as of November 30.
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| ARBK | Hot Stocks13:05 EST Argo Blockchain in 'advanced negotiations' to sell certain assets
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| ARBK | Hot Stocks13:04 EST Argo Blockchain says 'has not filed for bankruptcy at this time'
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| ARBK | Hot Stocks13:04 EST Argo Blockchain announces restoration of trading on London Stock Exchange - Argo Blockchain made the following announcement to the London Stock Exchange: "The company is at risk of having insufficient cash to support ongoing business operations within the next month. The company is in advanced negotiations with a third party to sell certain assets and engage in an equipment financing transaction that the company believes will strengthen its balance sheet and improve its liquidity. The Company is hopeful that it will be able to consummate the transaction outside of a voluntary Chapter 11 bankruptcy filing in the United States, although there is no assurance that the Company can avoid such a filing. The Company engaged McDermott Will & Emery LLP as legal advisers, Berkeley Research Group, LLC as financial advisers, and Stifel GMP and its affiliate, Miller Buckfire & Co., LLC, as investment bankers, to assist the Company with analysing these strategic options. As part of this process, certain draft materials were inadvertently published as a test page on the company's website. The inadvertently published materials, which implied that the company was filing for Chapter 11 bankruptcy, led to the suspension of trading of the company's securities on the London Stock Exchange and Nasdaq on Friday, 9 December 2022. Shareholders should note that the company has not filed for bankruptcy at this time. The company has requested that the UK Financial Conduct Authority restore the listing of its ordinary shares and that is expected to happen as soon as practicable."
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| ARBK | Hot Stocks13:03 EST Argo Blockchain says at risk of insufficient cash to support business
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| BAESY | Hot Stocks13:02 EST U.S. Navy awards BAE Systems $294M contract for USS Kearsarge modernization - BAE Systems has received a $294.7M contract from the U.S. Navy to drydock and perform more than 20 months of maintenance and modernization work on the amphibious assault ship USS Kearsarge. The contract includes options that, if exercised, would bring the cumulative value to $340.3M. Under the awarded contract, the maintenance availability of USS Kearsarge will begin in April. Starting in June, the 843-foot-long ship will be drydocked for nearly a year at BAE Systems' Norfolk shipyard. The shipyard will perform extensive hull, tank, and mechanical work, rehabilitate all crew and embarked Marine living compartments onboard, and inspect the ship's boilers. BAE Systems is expected to complete work aboard the 29-year-old ship in January 2025.
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| WMT... | Hot Stocks12:48 EST CVS, Walgreens in $10.7B opioid settlement with attorneys general - Oregon Attorney General Rosenblum, along with "many" attorneys general across the country, announced a national agreement with CVS Health (CVS) and Walgreens Boots Alliance (WBA) for the pharmacies' conduct in fueling the opioid epidemic. Under the agreements, CVS will pay $5B and Walgreens will pay $5.7B, totaling $10.7B. A certain number of states will need to sign onto the agreements for the full amount to be distributed, Rosenblum said in a statement. In addition to the financial settlement, CVS and Walgreens have agreed to court-ordered injunctive relief that requires the pharmacies to monitor, report, and share data about suspicious activity related to opioid prescriptions. The terms of these agreements will now go to the states for their review. Each state will have until the end of 2022 to join, after which the Walmart (WMT), Walgreens, and CVS agreements will go to local governments around the country for sign-on during Q1 of 2023. A sufficient percentage of states and local governments must join the settlements for them to go into effect, Rosenblum pointed out. Most of Walmart's amount will be paid during the first year; CVS's payments will be spread over 10 years; Walgreens' payments will be spread over 15 years. If there is sufficient sign-on, payments will begin during the second half of 2023, according to Rosenblum. Reference Link
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| NUWE | Hot Stocks12:02 EST Nuwellis Inc trading resumes
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| TAL | Hot Stocks12:01 EST TAL Education falls -15.7% - TAL Education is down -15.7%, or -$1.03 to $5.58.
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| UTI | Hot Stocks12:01 EST Universal Technical falls -16.3% - Universal Technical is down -16.3%, or -$1.17 to $5.99.
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| BAMR | Hot Stocks12:01 EST Brookfield Asset Management Reinsurance falls -21.3% - Brookfield Asset Management Reinsurance is down -21.3%, or -$9.18 to $34.00.
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| FXLV | Hot Stocks12:01 EST F45 Training rises 16.4% - F45 Training is up 16.4%, or 48c to $3.40.
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| MSC | Hot Stocks12:01 EST Studio City rises 20.4% - Studio City is up 20.4%, or 96c to $5.65.
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| WEBR | Hot Stocks12:00 EST Weber rises 23.3% - Weber is up 23.3%, or $1.52 to $8.02.
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| NUWE | Hot Stocks11:57 EST Nuwellis Inc trading halted, volatility trading pause
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| MYCOF | Hot Stocks11:41 EST Mydecine closes sale of Mindleap Health to PanGenomic - Mydecine Innovations Group closed the sale of all of the issued and outstanding shares of its wholly-owned subsidiary, Mindleap Health to PanGenomic Health. The sale of Mindleap is a significant step towards refocusing the Company's resources on its primary strategy of discovering and developing innovative pharmaceutical psychedelic substances to meet the unmet needs of millions of patients worldwide. PanGenomic acquired all of Mindleap's outstanding shares for a purchase price of C$3,600,000, payable by the issuance of units of PanGenomic at a price of C$0.20 per Unit. Each Unit was comprised of one Class A Common Share of PanGenomic and one share purchase warrant to purchase one additional Common Share at a price of C$0.30 per Unit Warrant Share until December 8, 2024. In support of the Transaction, the Company and PanGenomic entered into a transition services agreement whereby PanGenomic engaged Mydecine to assist in the transition, transfer, and integration of Mindleap's technologies into PanGenomic's technology platform for two months. In return for the Services, PanGenomic will pay to Mydecine a consulting fee of C$100,000, payable on January 8, 2023. Upon completion of the Transaction, Mydecine holds approximately 19.4% of the issued and outstanding Common Shares.
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| RHHBY | Hot Stocks11:39 EST Genentech presents data on glofitamab, mosunetuzumab potential at ASH 2022 - Genentech announced that updated clinical data for its CD20xCD3 T-cell engaging bispecific antibodies, including five oral presentations, were presented at the 64th American Society of Hematology Annual Meeting & Exposition, December 10-13, 2022. Updated results for the investigational bispecific glofitamab in people with relapsed or refractory large B-cell lymphoma suggest glofitamab has the potential to be the first off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pretreated aggressive lymphoma. These data will be presented at the meeting and simultaneously published online in the New England Journal of Medicine. Additionally, updated data for mosunetuzumab continued to demonstrate clinically meaningful outcomes in people with heavily pretreated follicular lymphoma. Mosunetuzumab is a fixed-duration treatment that can be administered in the outpatient setting, which could allow people the possibility of experiencing a lasting remission with a treatment-free period. Pivotal Phase II Glofitamab Data Presented at ASH 2022 and Published in NEJM: Updated data from the pivotal Phase II NP30179 study in people with R/R LBCL showed glofitamab given as a fixed course induced early and durable responses that were maintained beyond the end of treatment. Most patients who had achieved a complete response at the end of treatment experienced durable responses, with a median CR follow-up from end of treatment of 11.5 months. Twelve months after the end of treatment with glofitamab, 61% of patients maintained a CR, 92.6% remained progression-free, and only one patient experienced disease progression. Simultaneously, an earlier data cut from the Phase II NP30179 study in R/R diffuse large B-cell lymphoma was published online in NEJM. Data from this pivotal Phase II study have been submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration, are ongoing. Updated Pivotal Phase II Mosunetuzumab Data Presented at ASH 2022: An updated analysis from the pivotal Phase II GO29781 study of mosunetuzumab in people with R/R FL who had received two or more prior therapies showed 60.0% achieved a CR and 77.8% achieved an objective response at a median follow-up of 28.3 months. After 24 months of achieving a CR, 62.7% of patients remained in remission. Overall, 48.3% of patients remained progression-free. The median duration of response, median duration of CR, and median progression-free survival were not reached. Safety was consistent with the previous analysis of study data, with no new cytokine release syndrome events or Grade 3 or higher adverse events reported. CRS events were experienced by 44% of patients and were predominately low grade and during cycle one. Additional Mosunetuzumab and Glofitamab Data Presented at ASH 2022: Genentech continues to evaluate mosunetuzumab and glofitamab as part of its commitment to providing off-the-shelf therapies for people with lymphomas that can meet their diverse needs, including fixed-duration treatment options. Additional data presented at ASH 2022 include the following: A subcutaneous formulation of mosunetuzumab demonstrated comparable efficacy with the intravenous formulation and a manageable safety profile in people with R/R non-Hodgkin's lymphoma. The most common AEs were injection site reactions and CRS events, which were all Grade 1 or 2. These findings suggest that a SC formulation of mosunetuzumab may offer patients a treatment option that could reduce their time spent in treatment centers. Updated results from the Phase I/II G050554 study of mosunetuzumab monotherapy in elderly/unfit patients with previously untreated DLBCL and additional analyses from the Phase I/II G040516 study of mosunetuzumab in combination with Polivy in heavily pretreated people with DLBCL continued to show promising efficacy and manageable safety, highlighting the potential of mosunetuzumab in these patient populations.Results from the Phase I/II NP30179 study evaluating glofitamab as a monotherapy following pretreatment with obinutuzumab in patients with heavily pretreated R/R mantle cell lymphoma continued to show early, high and durable response rates in this difficult-to-treat disease. After a median follow-up of eight months, the overall response rate was 83.8%, with the majority of patients showing durable complete responses at the data cut off. The most common AE was CRS, with the majority low grade. Data from the safety and expansion cohorts of the Phase Ib NP40126 study evaluating glofitamab in combination with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated DLBCL showed, after a median follow-up of 8.5 months, a best ORR of 92.7% and a complete metabolic response rate of 72.7%. In the safety cohort, CRS events were all low grade, and serious AEs were reported in 18 patients. Both mosunetuzumab and glofitamab are being investigated as SC formulations and in Phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of continuing to address the diverse needs and preferences of people with blood cancers. This includes the confirmatory Phase III CELESTIMO study investigating mosunetuzumab plus lenalidomide as a chemotherapy-free option for patients with R/R FL; the Phase III SUNMO study investigating mosunetuzumab plus Polivy versus rituximab in combination with gemcitabine plus oxaliplatin in patients with R/R aggressive B-cell NHL who are ineligible for autologous stem cell transplant; and the Phase III STARGLO study evaluating glofitamab in combination with gemcitabine and oxaliplatin versus rituximab in combination with GemOx in patients with R/R DLBCL who are ineligible for ASCT.
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| IMGO | Hot Stocks11:34 EST Imago BioSciences presents data from Phase 2 study of bomedemstat in ET - Imago BioSciences presented data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with essential thrombocythemia who have failed at least one standard of care. The data were presented in an oral presentation session during the 64th American Society of Hematology Annual Meeting and Exposition taking place 10-13 December 2022. A Phase 2 data set with a cut-off date of 29 April 2022 was previously presented at the 30th European Hematology Association Annual Meeting and congress in June 2022. Updated Highlights: Of the 62 Patients treated with bomedemstat for more than 24 weeks: 100% achieved platelet count reduction to less than or equal to 400 x 109/L. 95% achieved platelet count reduction to less than or equal to 400 x 109/L in the absence of thromboembolic events. 89% of the 28 patients treated with bomedemstat for at least 48 weeks achieved a durable response by week 48, defined as platelet count of less than or equal to 400 x 109/L for greater than or equal to 12 weeks. Of the 12 patients with baseline Total Symptom Scores greater than 20:75% showed a decrease in TSS. 67% showed improvements greater than or equal to 10 points.Platelet response rate was 100% across all genotypes identified in the study. Further, 67% patients demonstrated a net decrease in mutation allele frequencies including both CALR and JAK2. 100% patients with baseline loss of heterozygosity and follow-up samples demonstrated a reduction in homozygous mutant granulocytes and mutant allele frequencies.Bomedemstat was generally well-tolerated with no safety signals identified per the Safety Advisory Board.The most common adverse events regardless of causality were dysgeusia, constipation, thrombocytopenia, arthralgia, fatigue, contusion and diarrhea. There were 38 reported serious adverse events, 7 of which were deemed drug-related by the investigator in 5% of patients. 20 patients have discontinued treatment, with 10 due to AEs, 1 death from aspiration pneumonia unrelated to bomedemstat, 7 due to withdrawal of consent, 1 due to investigator decision, and 1 due to disease progression.
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| PRTA | Hot Stocks11:32 EST Prothena presents data from phase 3 VITAL study - Prothena Corporation presented data from the completed phase 3 VITAL study demonstrating that in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis, a statistically significant survival benefit was observed in those treated with birtamimab at 9 months. The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in patients with Mayo Stage IV AL amyloidosis. The data were presented in an oral presentation at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, LA.Birtamimab is a potential best-in-class amyloid depleter treatment for AL amyloidosis. Based on the totality of the VITAL study data, Prothena has advanced birtamimab into the confirmatory Phase 3 AFFIRM-AL study in patients with Mayo Stage IV AL amyloidosis under a Special Protocol Assessment agreement with the U.S. FDA with a primary endpoint of all-cause mortality at pless than or equal to0.10. Confirmatory Phase 3 AFFIRM-AL topline data is expected in 2024. A post hoc analysis of patients with Mayo Stage IV AL amyloidosis showed a statistically significant survival benefit of 74 percent in patients treated with birtamimab versus a survival benefit of 49 percent in patients on placebo at 9 months. The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in Mayo Stage IV patients, reinforcing the strength of the survival data in these patients at high risk of early mortality. The sensitivity analysis was performed as part of the post hoc analysis of patients with Mayo Stage IV AL amyloidosis. After adjusting for baseline demographic, clinical, and laboratory variables, the adjusted hazard ratios ranged from 0.336 to 0.465, with no upper bounds of the 90% confidence interval crossing 1, indicating a consistent survival benefit with birtamimab at 9 months. Birtamimab also demonstrated statistically significant improvement over placebo in post hoc analyses of quality of life and cardiac function. Patients treated with birtamimab showed a mean difference of 4.65 in the SF-36v2 PCS over placebo at 9 months. Mayo Stage IV patients treated with birtamimab after 9 months demonstrated an increase of 15.22 meters in the 6-minute walk test, whereas patients treated with placebo had a decrease of 21.15 meters. Birtamimab was generally safe and well tolerated in the overall patient population and in Mayo Stage IV patients. The rates of treatment emergent adverse events were balanced between treatment arms. The rates of treatment-related TEAEs were similar or lower with birtamimab than in the placebo arm of both the overall population and in Mayo Stage IV patients. Consistent with AL amyloidosis, cardiac disorder was the most common class of fatal TEAEs. There were no fatal TEAEs that were considered treatment related.
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| VENA MLGO | Hot Stocks11:27 EST Venus Acquisition closes business combination, MicroAlgo to trade on Nasdaq - Venus Acquisition Corporation announced that, on December 9, 2022, the Company closed the previously announced business combination with VIYI Algorithm pursuant to which the Venus Merger Sub, a Cayman Islands exempted company incorporated for the purpose of effectuating the Business Combination merged with and into VIYI, with VIYI surviving the merger to become a wholly owned subsidiary of Venus. Venus is a publicly traded special purpose acquisition company or SPAC.As part of the transaction, the Company changed its name to "MicroAlgo Inc." As a result, the Company expects that its ordinary shares will begin trading on The Nasdaq Capital Market under the ticker symbol "MLGO", starting on or about December 13, 2022, and that its units and rights will cease trading on December 12, 2022. The Company was informed by Nasdaq that the warrants did not satisfy initial listing requirements and would be delisted from Nasdaq on or about December 21, 2022. The Company will remain listed and trading under its current name and trading symbol on December 12, 2022. In connection with the Business Combination, the Company's units, each of which is comprised of one Ordinary Share, one warrant to purchase one-half of one Ordinary Share and one right, have been separated into their component securities, and the 4,600,000 public rights have been converted into 460,000 Ordinary Shares. In addition, 225,000 rights held by Yolanda Management Corporation have been converted into 22,500 Ordinary Shares.
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| BAESY | Hot Stocks11:23 EST Slovakia signs $1.37B government-to-government deal for 152 CV90s - As part of a government-to-government agreement between Sweden and the Slovak Republic, the Ministry of Defence of the Slovak Republic has signed a $1.37B agreement for the delivery of 152 CV9035 infantry fighting vehicles from BAE Systems. The CV90s will be produced and delivered in several configurations with the full cooperation of Slovak industry including ZTS - SPECIAL as the main industry partner to BAE Systems. Other Slovak state-owned and private companies will take critical roles in producing the vehicles and supporting the program in the longer term.The Slovak Army will receive the newest iteration of the CV9035, known as the CV90MkIV, with the latest advanced capabilities and digital technology. The vehicle combines improved battlefield speeds and handling with an upgraded electronic architecture to support future growth and meet the needs of the evolving battlefield.
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| PBF | Hot Stocks11:14 EST PBF Energy announces $500M share repurchase program - PBF Energy announced that its board of directors has authorized the repurchase of up to $500M of PBF Class A common stock. "These repurchases may be made from time to time through various methods, including open market transactions, block trades, accelerated share repurchases, privately negotiated transactions or otherwise, certain of which may be effected through Rule 10b5-1 plans. The timing and number of shares repurchased will depend on a variety of factors, including price, capital availability, legal requirements and economic and market conditions. PBF is not obligated to purchase any shares under the repurchase program, and repurchases may be suspended or discontinued at any time without prior notice," the company noted.
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| STLA DTE | Hot Stocks11:03 EST Stellantis partners with DTE Energy to add 400MW of solar projects in Michigan - Stellantis (STLA) and DTE Energy (DTE) announced a clean energy commitment to add 400 megawatts of new solar projects in Michigan through DTE's MIGreenPower voluntary renewable energy program. With its participation in MIGreenPower, Stellantis said it will be able to attribute 100% of its electricity use at 70 southeast Michigan sites to solar by 2026, which will reduce the company's carbon emissions in North America by 50% and across its manufacturing facilities by 30%.
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| YELL CAH | Hot Stocks11:01 EST Yellow Corp appoints Annlea Rumfola as CIO - Yellow Corporation announces the appointment of Annlea Rumfola as its new Chief Information Officer. She will oversee all information technology teams, systems, processes and support functions at Yellow, reporting directly to CEO Darren Hawkins. Rumfola will step into the CIO role on Jan. 3, 2023. Current CIO Jason Ringgenberg is retiring after serving in that position since 2017. Rumfola brings an extensive background in technology leadership from Cardinal Health Inc., where she most recently served as senior vice president of information technology for the health care company's medical segment
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| ARQQ | Hot Stocks11:00 EST Arqit Quantum, Traxpay sign contract to deliver secure trade finance - Arqit Quantum signed a contract with Traxpay to deliver quantum-safe digital finance instruments, enabling supply chain actors to conduct business more efficiently and securely in the new digital trade era. Deployed directly into Traxpay's supply chain financing platform which has processed over EUR 65bn of supply chain finance assets to date, Arqit's TradeSecure service uses distributed ledger technology to provide customers with referenceable digital finance instruments, which are easier to manage than paper-based alternatives, unique, transferable and invariable. Arqit's symmetric key agreement software, QuantumCloud provides provable quantum-safe security for Traxpay's customers, protecting them from current and future cyber threats.
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| NKTR | Hot Stocks10:59 EST Nektar announces presentations on NKTR-255 at ASH annual meeting - Nektar Therapeutics announced two presentations of NKTR-255 at the 64th American Society of Hematology Annual Meeting. NKTR-255 is an investigational IL-15 receptor agonist designed to boost antitumor immunity by increasing the proliferation and survival of natural killer and memory CD8+ T cells, thereby enhancing the formation of long-term immunological memory, which may lead to sustained antitumor immune response. The study design of an upcoming Phase 2/3, randomized, double-blind, placebo-controlled, multicenter clinical trial of NKTR-255 following CD19-directed chimeric antigen receptor T cell therapy in patients with relapsed/refractory large B-cell lymphoma was presented by Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service, at Memorial Sloan Kettering Cancer Center on Sunday, December 11th. Pre-clinical studies demonstrate that NKTR-255 can potentiate the effects of CAR-T therapies and a number of early clinical studies are currently underway to evaluate the role of NKTR-255 following CAR-T cell treatment for different hematologic malignancies. Additionally, results from the ongoing Phase 1 study of NKTR-255 as a monotherapy and in combination with daratumumab in patients with R/R multiple myeloma or non-Hodgkin's lymphoma were presented by Krina Patel, M.D., Associate Professor, Department of Lymphoma-Myeloma, at the University of Texas MD Anderson Cancer Center on Monday, December 12th. The data showed that NKTR-255 resulted in an expansion and proliferation of NK cells following daratumumab's on-target depletion of CD38-expressing NK cells. Abstract 3335: "A Phase 2/3, Randomized, Double Blind, Placebo-Controlled, Multicenter Study of NKTR-255 Vs Placebo Following CD-19 Directed CAR-T Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma", Perales M., et al. Based on preclinical and clinical evidence, NKTR-255 has the potential to improve efficacy of currently approved cellular therapy by enhancing antitumor effect and durability of responses. The upcoming Phase 2/3 study will enroll eligible patients with R/R LBCL who have received an FDA-approved CAR-T cell product. Patients will receive NKTR-255 intravenously, starting approximately 14 days following CAR-T therapy, with continued dosing every 21 days. The primary objective of the Phase 2 portion of the study is to identify the dose of NKTR-255 for the Phase 3 portion of the study based on safety, tolerability, and complete response rate at month 6, the primary efficacy endpoint. Abstract 4652: "Safety, Tolerability, PK/PD and Preliminary Efficacy of NKTR-255, a Novel IL-15 Receptor Agonist, in Patients with Relapsed/Refractory Hematologic Malignancies", Patel K., et al. NKTR-255 was well tolerated in heavily pre-treated patients with hematologic malignancies in doses up to 12 undefined/kg and in combination with daratumumab in doses up to 9 undefined/kg. The majority of treatment-related adverse events were low-grade, transient, and easily managed. The maximum tolerated dose was not reached.No new safety signals or overlapping toxicities were observed with the doublet and dose escalation is ongoing. Early evidence of clinical activity was observed in this heavily pre-treated and highly refractory patient population with the doublet. Peak fold-changes of ~17-fold NK cell and ~2-fold in CD8+ T cell expansion were observed in the first 2 cycles with NKTR-255 monotherapy doses up to 12 undefined/kg. Sustained proliferative ability of NK and CD8+ T cells across multiple cycles indicated no evidence of tachyphylaxis. Preliminary data from patients previously treated with off-the-shelf allogenic CAR-T cells indicate that allo-CAR-T cells persisted with NKTR-255 monotherapy, suggesting no alloreactivity to off-the-shelf allo-CAR-T cells.With combination therapy, NK cell rescue was observed with sustained increases in NK and CD8+ T cells despite daratumumab's on-target depletion of CD38 expressing NK cells.
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| REGN | Hot Stocks10:55 EST Regeneron announces data from Phase 2 trial of linvoseltamab - Regeneron Pharmaceuticals announced initial data from a pivotal Phase 2 expansion cohort evaluating investigational linvoseltamab at the 200 mg dose recommended for further development in patients with heavily pre-treated, relapsed/refractory multiple myeloma. The results were part of a broader presentation of new and updated data from a Phase 1/2 trial and were shared at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, LA. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. As presented at ASH, out of 252 patients treated in the Phase 1/2 trial, 81% of patients were triple-refractory to existing therapeutic options, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. Additionally, 37% had bone marrow plasma cells greater than or equal to50%, and the median soluble BCMA was 0.43 mg/L, representing a patient population with a higher disease burden than those enrolled in similar trials. Of the 87 patients in the 200 mg cohort, 58 were evaluated for efficacy. With a median follow-up of 3 months efficacy results were as follows: 64% objective response rate, with 45% achieving a very good partial response or better, as determined by an independent review committee. Based on earlier results, responses may increase with longer follow-up. Median time to response was less than1 month. 79% probability of maintaining a response at 6 months, per Kaplan-Meier estimates. Among the 87 patients treated in the 200 mg cohort assessed for safety, adverse events occurred in 95% of patients, with 66% being greater than or equal toGrade 3. The most common AEs occurring in greater than or equal to20% of patients were cytokine release syndrome, fatigue, anemia, diarrhea, cough, headache and neutropenia. Discontinuations due to an AE occurred in 6% of patients. When CRS occurred, in 32 out of 87 patients, 23 of those patients experienced Grade 1, 8 experienced Grade 2, there was 1 transient Grade 3 case, and none were greater than or equal toGrade 4. Among the overall patient population across different dose levels, the median time to first CRS onset was 11 hours and all cases resolved, with a median time to resolution of 15 hours. Deaths due to AEs in the overall population were reported in 14 patients, including sepsis/bacterial infection, COVID-19 or other causes. None of the deaths were considered related to treatment per the treating physician.
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| CRIS | Hot Stocks10:51 EST Curis announces clinical data from TakeAim Leukemia Study of emavusertib - Curis announced positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib, a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. Patients in a targeted population are those with disease harboring U2AF1, SF3B1 or FLT3 mutations. The company also announced positive initial data of emavusertib in combination with venetoclax in patients with AML or hrMDS that enrolled in the combination phase of the TakeAim Leukemia study prior to the partial clinical hold placed in April 2022. As of October 12, 2022, the total monotherapy data to date represents 24 response evaluable patients with a targeted mutation and 34 response evaluable patients without a targeted mutation. This represents 11 additional patients treated in targeted monotherapy populations and 13 additional patients in the non-targeted monotherapy population. In addition to the monotherapy data, there are 4 patients with AML/hrMDS who have been treated with emavusertib in combination with venetoclax. In Expanded Data Set, Findings Support Earlier Data Presented in June 2021 and January 2022 Previous data presented by Curis highlighted preliminary efficacy data of emavusertib in R/R AML/MDS patients whose disease is characterized by spliceosome or FLT3 mutation. It is this genetically-defined subset of AML/MDS that is specifically targeted by emavusertib and which we believe, represents the patients most likely to benefit from treatment with emavusertib in monotherapy. Today's clinical data update provides an expanded data set for this genetically-defined patient population. In targeted AML patient monotherapy populations key findings included: Patients with a FLT3 mutation had a CR rate of 29%; In addition to the 2 patients who achieved CRs, a 3rd patient achieved MLFS, and a 4th patient with gilteritinib-refractory disease achieved near normalization of blast count and complete loss of detectable FLT3 clone Patients with a spliceosome mutation had CR/CRh rate of 22%. In targeted hrMDS patient monotherapy populations key findings included: ORR of 45%. All 5 responses achieved a marrow CR. In combination AML/hrMDS patient populations key findings included: ORR of 50%. Both responses achieved mCR. These data continue to confirm the earlier data that emavusertib provides favorable anti-cancer activity in AML and hrMDS patients with a spliceosome and/or FLT3 mutation. Further, anti-cancer activity in non-targeted patients as well as in combination with venetoclax suggest potential for incremental efficacy in combination with existing therapies. We are continuing to enroll patients at the 200mg dose level and plan to discuss with the U.S. Food and Drug Administration a recommended phase 2 dose in mid-2023.
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| PANW | Hot Stocks10:49 EST Palo Alto Networks, Red Canary expand partnership - Red Canary announced a new integration with Palo Alto Networks, adding Cortex XDR and broadening its detection coverage for mutual customers. This deepening of the partnership between the two companies builds on existing Red Canary integrations, including PAN-OS, Advanced Threat Prevention, and WildFire.
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| AFMD | Hot Stocks10:48 EST Affimed presents updated data from AFM28 - Affimed presented a poster highlighting new preclinical data for its Innate Cell Engager AFM28 targeting CD123 and CD16A at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, Louisiana. The data demonstrated the ability of AFM28 to effectively redirect allogeneic NK cells and induce depletion of CD123-positive leukemic blasts and leukemic stem cells in ex vivo patient samples, underscoring its potential as a novel therapeutic agent in AML. AFM28 is a novel ICE in development for treatment of patients with myeloid diseases that have undergone multiple prior treatments and have relapsed or are refractory to standard of care. It is designed to bind to natural killer cells and CD123-positive tumor cells to induce tumor cell killing. To date, the program has shown strong anti-tumor activity in vivo while maintaining a good safety profile.AML is a difficult-to-treat disease with low cure rates and significant toxicities associated with available therapies. There is an urgent need for new approaches that are effective, provide long-term, relapse-free survival and are better tolerated. AFM28 holds promise as a novel safe and effective therapeutic that could address the needs of underserved patients with AML. The poster presented at ASH featured detailed preclinical evaluations further characterizing AFM28 and its mechanisms of action in models of AML. The data confirmed a concentration-dependent, NK cell-mediated lysis of CD123-positive target cells in different tumor lines, irrespective of low CD123 expression or mutational status. In addition, high CD64 expression, which negatively affects antibody-dependent cellular cytotoxicity of conventional and Fc-enhanced anti-CD123 antibodies, did not affect AFM28 efficacy. A critical factor for long-term remission in AML patients is the efficient and safe depletion of leukemic blasts and corresponding stem cells. In ex vivo AML and MDS bone marrow samples, AFM28 induced the depletion of CD123-positive leukemia stem cells and leukemic progenitor cells while sparing healthy cells, suggesting the ability to induce deep, anti-tumor responses without irreversible bone marrow suppression. The ICE also showed inhibition of tumor growth in murine AML models, underscoring the anti-tumor activity of the program. Affimed remains on track to initiate clinical development of AFM28 with a first-in-human phase 1 monotherapy trial in adult patients with R/R AML in the first half of 2023. In addition, Affimed plans to investigate AFM28 in combination with allogeneic NK cell therapy after a safe starting dose has been determined.
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| CRSP | Hot Stocks10:46 EST Crispr Therapeutics provides update on ongoing Phase 1 CARBON trial - CRISPR Therapeutics provided an update for both Part A and Part B of the Company's ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR T cell therapy targeting CD19+ B-cell malignancies. Part A data, presented at ASH, showed the potential for CTX110 to achieve long-term durable complete remissions with a positively differentiated safety profile in heavily pre-treated patients, and emerging data from Part B showed an encouraging efficacy profile with several patients in ongoing CR beyond six months. The Phase 1 CARBON trial is an open-label, multicenter clinical trial evaluating the safety and efficacy of CTX110 in adult patients with relapsed or refractory CD19+ B-cell malignancies who have received at least two prior lines of therapy. To date, enrollment has been focused on patients with the most aggressive disease presentations, including Diffuse Large B-cell Lymphoma not otherwise specified, high-grade double- or triple-hit lymphomas, transformed follicular lymphoma, and grade 3B follicular lymphoma. In Part A of the trial, patients were infused with a single dose of CTX110 following three days of a standard lymphodepletion regimen consisting of fludarabine and cyclophosphamide. Patients received CTX110 at doses ranging from Dose Level to DL4, with an option to re-dose CTX110 based on clinical benefit. In Part B of the trial, patients received CTX110 at DL4 following standard lymphodepletion, as well as a consolidation dose of CTX110 at the same dose level between four and eight weeks after the initial dose for patients that demonstrate clinical benefit. The primary endpoints include safety as measured by the incidence of dose limiting toxicities and overall response rate. Key secondary endpoints include complete response rate, duration of response and overall survival. PART A: Data presented at ASH show the potential for single infusions of CTX110 to achieve long-term durable complete remissions with a positively differentiated safety profile. In a heavily pre-treated patient population with relapsed or refractory LBCL, CTX110 at DLgreater than or equal to3 resulted in an ORR of 67% and CR rate of 41%. Three patients remain in ongoing CR two years after treatment, and two additional patients remain in CR past one year. No DLTs, no Graft versus Host Disease of any grade, and no Grade greater than or equal to3 cytokine release syndrome events were observed.These data formed the basis for Regenerative Medicine Advanced Therapy designation by the FDA for CTX110, granted in November 2021. PART B: Emerging data from Part B shows an encouraging efficacy profile with several patients in ongoing CR beyond six months. Clear evidence of the benefits of consolidation dosing was observed, with deepening of CRs and conversions of stable disease and partial response to ongoing CRs after the second dose. Safety profile remained consistent with Part A, confirming the tolerability of the consolidation regimen. Peak expansion and overall pharmacokinetics of CTX110 were comparable between the initial and consolidation doses. The Company plans to present additional Part B data at a future medical meeting. Following discussions with regulatory agencies, the Company has initiated a single-arm, potentially registrational trial of CTX110, which incorporates consolidation dosing at DL4 and standard lymphodepletion. Dosing in this trial is expected to begin in early 2023 using drug product manufactured with a commercial-ready process and specifications.
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| IMGO | Hot Stocks10:43 EST Imago BioSciences presents data from ongoing Phase 2 study of bomedemstat - Imago BioSciences presented positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with advanced myelofibrosis. The data were presented in a poster presentation session during the 64th American Society of Hematology Annual Meeting and Exposition taking place 10-13 December 2022. A Phase 2 data set with a cut-off date of 29 April 2022 was previously presented at the 30th European Hematology Association Annual Meeting and congress in June 2022 Updated Highlights: Of evaluable patients at 24 weeks: 65% showed a decrease in Total Symptom Score. 19% showed a greater than or equal to 50% decrease in TSS. 66% showed spleen volume reductions from baseline. 28% showed a greater than or equal to 20% spleen volume reduction. The majority of patients had a decrease in mutant allele frequencies including driver mutations and high molecular risk mutations/ 90% of transfusion-independent patients had stable or improved hemoglobin at Week 12. 85% of patients had an improved or stable bone marrow fibrosis score post-baseline. No new mutations or transformations to acute myeloid leukemia while on treatment, even in patients with a high-risk of progression. Bomedemstat was generally safe and well-tolerated in patients with myelofibrosis. The most common non-hematologic adverse event related to bomedemstat was dysgeusia, which occurred in 33% of patients and led to discontinuation of the study in 1 patient. There were 44 patients who reported a total of 86 serious adverse events, 16% of which were deemed drug-related by the investigator.
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| KYMR | Hot Stocks10:40 EST Kymera Therapeutics presents on potential of STAT3 degraders - Kymera Therapeutics announced that preclinical data from collaborations for its STAT3 and IRAKIMiD degraders was presented at the American Society of Hematology Annual Meeting, taking place from December 10 - 13, 2022 in New Orleans, Louisiana. The first presentation, "Leveraging Pre-Clinical Animal Model of CTCL to Explore Therapeutic Potential of a Novel STAT3 Degrader," conveys the results of a study conducted in collaboration with the NYU School of Medicine using a STAT3-dependent model of CTCL that shares many key features of human disease. Cutaneous T cell lymphoma is a type of mature T cell lymphoma characterized by the accumulation of malignant T cells in the skin with upregulation of the STAT3 signaling pathway as a key driver of disease pathogenesis. The model was used to evaluate the therapeutic potential of one of Kymera's potent and selective STAT3 heterobifunctional degraders for targeting this difficult-to-treat hematologic malignancy. A single intravenous infusion of a STAT3 degrader led to substantial reduction in STAT3 levels in lymph node T cells, circulating T cells, and skin-resident T cells. Chronic weekly dosing on a 4 weeks on/1 week off schedule resulted in the dramatic amelioration of disease and prevented development of characteristic skin pathology. These data provide a rationale for selective STAT3 degradation as a therapeutic strategy for T cell malignancies such as CTCL that are associated with constitutive activation of STAT3 signaling. Kymera's lead STAT3 degrader, KT-333, is currently being evaluated in a Phase 1 clinical trial in liquid and solid tumors, including CTCL. The second presentation, "Precision Targeting of MYD88 Mutant DLBCL Using the Novel Combination of IRAKIMiDs and BCL2 Inhibition," was a research collaboration with the Department of Medicine, Lymphoma Service, at Memorial Sloan Kettering Cancer Center. Kymera has previously shown that IRAKIMiD degraders targeting IRAK4 and the IMiD substrates Ikaros and Aiolos have profound antitumor activity in CDX and PDX mouse models of MYD88-mutant DLBCL, where both the NF-kB and IRF4 pathways are upregulated by oncogenic MYD88 mutations. As BCL-2 upregulation has been seen in conjunction with NF-kB activation, the activity of BCL-2 inhibition combined with IRAKIMiDs was assessed in MYD88-mutant and -wild type DLBCL. Strong synergistic inhibition of cell growth and induction of apoptosis in vitro was seen with nanomolar concentrations of an IRAKIMiD combined with the BCL-2 inhibitor venetoclax in MYD88-mutant DLBCL cell lines. Weaker synergy with the combination was seen in wild-type MYD88 DLBCL. These data show the potential for IRAKIMiD/BCL-2 inhibitor combinations in MYD88-mutant DLBCL. Kymera's lead IRAKIMiD compound, KT-413, is currently being evaluated in a Phase 1 clinical trial in B cell lymphoma, including MYD88-mutant DLBCL.
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| CRVS | Hot Stocks10:39 EST Corvus Pharmaceuticals presents updated data from CPI-818 Phase 1/1b trial - Corvus Pharmaceuticals announced updated results from its Phase 1/1b trial of CPI-818, the Company's ITK inhibitor, which demonstrated its anti-tumor activity in patients with T cell lymphoma and its therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases. The data will be presented today in a poster at the 64th American Society of Hematology Annual Meeting & Exposition, which is taking place in-person and virtually from December 10 to 13, 2022. CPI-818 is being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of September 2, 2022, 43 patients were enrolled in the trial across four escalating dosing cohorts: 100, 200, 400 and 600 mg, each being administered twice per day. The 200 mg dose was found to provide plasma drug concentrations that optimally affect T cell differentiation in vitro and correspondingly was found to lead to the most frequent and durable tumor responses in vivo. Accordingly, Corvus identified it as the optimal dose and additional patients are being enrolled in a 200 mg dose cohort of the clinical trial. The Phase 1/1b clinical trial endpoints are safety, pharmacokinetics, immunologic effects and tumor response. T Cell Lymphoma Interim Data Highlights: 13 patients were enrolled in the 200 mg cohort and 11 were evaluable for response. Overall objective responses were seen in 4 of 11 patients. Enrolled patients were heavily pretreated receiving a median of 3 prior therapies. In this group, there was one complete response lasting 25 months in a patient with peripheral T cell lymphoma; one nodal CR lasting 19 months in a patient with cutaneous T cell lymphoma; and two partial responses ongoing at six and eight months follow up, respectively, in patients with PTCL and anaplastic large cell lymphoma. An additional patient in the 600 mg cohort also had a PR. No dose limiting toxicities were observed, and a maximally tolerated dose was not reached at doses as high as 600 mg twice per day. All of the foregoing data was as of September 2, 2022. Immunologic Effects Interim Data Highlights: As of September 2, 2022, the 200 mg optimal dose was shown to induce Th1 skewing and both Th2 and Th17 blockade based on peripheral blood samples from several patients: In one patient that had a significant reduction of a large tumor on the abdominal wall, a blood sample analysis demonstrated an increase in blood Th1, a decrease in blood Th17, and a reduction of eosinophil count and IL-5 consistent with Th1 skewing and Th2 blockade. Tumor samples in this patient were also analyzed and showed an increase in terminally differentiated T effector memory cells, which are T cells that have responded to an antigen and are able to mediate effector functions, such as the destruction of tumor cells. In four patients, the change in Th1 and CD8+ TEMRA cells was serially measured over time. The PR and SD patients showed an increase in both Th1 and CD8+ TEMRA cells. Of note, SD and PD patients were lymphopenic at baseline with absolute lymphocyte counts less than1,000, highlighting the need for a minimal level of immune competence. In vitro data demonstrated that CPI-818 induced Th1 skewing and Th2 blockade in a dose-dependent manner that supported the selection of the 200 mg dose. This includes an analysis of peripheral blood samples from 12 healthy volunteers that were stimulated in the presence of various concentrations of CPI-818 and other studies that showed that CPI-818 inhibited Th2 cytokine production from normal CD4+ and Sezary cells. Other in vitro studies showed that CPI-818 inhibited the production of interleukin 4, 5 and 13 cytokines produced by Th2 cells.Increase in infiltration of normal CD8+ T cells in the tumor and inhibition of tumor growth. The findings of the human and preclinical studies suggest that CPI-818 enhances anti-tumor immunity representing a potentially novel approach to immunotherapy. Separate from the ASH presentation, Corvus recently initiated a CPI-818 study in companion dogs with naturally occurring, refractory atopic dermatitis. Early results from this study demonstrated CPI-818's potential activity in this disease with five out of five treated dogs responding to therapy within 14 days.
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| ALXO | Hot Stocks10:37 EST ALX Oncology announces initial data from ASPEN-05 study - ALX Oncology Holdings announced the presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory or newly diagnosed acute myeloid leukemia. The new results, shared in a poster at the 64th American Society of Hematology Annual Meeting, show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks or 60 mg/kg once every 4 weeks together with standard dosing of azacitidine and venetoclax. Evorpacept in combination with azacitidine and venetoclax was generally well tolerated with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W. In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response.In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response 1 CR with incomplete hematologic recovery, and 1 morphologic leukemia free state .
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| KROS | Hot Stocks10:35 EST Keros Therapeutics presents clinical data from KER-050, KER-047 programs - Keros Therapeutics presented additional data from its ongoing Phase 2 clinical trial of KER-050 in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes as well as initial data from its ongoing Phase 2 clinical trial of KER-050 in patients with myelofibrosis and from its ongoing Phase 2 clinical trial of KER-047 in patients with iron-refractory iron deficiency anemia, at the 64th American Society of Hematology Annual Meeting and Exposition, held in person and virtually December 10 through 13, 2022. In addition, Keros presented preclinical data showing the potential of a research form of KER-050 to treat anemia and bone loss in an animal model of MDS, as well as preclinical data evaluating the treatment effect of activin receptor-like kinase 2 inhibition combined with RKER-050 in a mouse model of anemia of inflammation. "We are pleased to present clinical and preclinical data from our lead hematological programs at ASH this year. In our ongoing Phase 2 clinical trial in MDS, we observed a sustained response with longer-term treatment with KER-050 across all transfusion burdens. Data from our ongoing Phase 2 trial in MF support the potential for KER-050 to treat multiple cytopenias as either a monotherapy or in combination with ruxolitinib," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "In addition, clinical data from one IRIDA patient in our Phase 2 clinical trial of KER-047 was suggestive of iron redistribution consistent with KER-047's mechanism of action."
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| CNHI | Hot Stocks10:33 EST CNH Industrial opens new technical center in Detroit - CNH Industrial announced during its Tech Day in Phoenix, Arizona, USA, that it has opened a new technical center in the Detroit Metro area of Michigan, USA. Designed to support our growing innovation in electrification, the center will enhance CNH Industrial's technology capabilities. This is facilitated by its proximity to a nationwide hub for electrification OEMs and suppliers. This new site will complement and partner with the Company's existing electrification site in San Matteo, Modena, Italy. Together, they will further our leading position in alternative propulsion - built on over 15 years of R&D experience and commercially available products.
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| NWS | Hot Stocks10:32 EST News Corp. appoints Emma Tucker as Editor-in-Chief of The Wall Street Journal - Emma Tucker has been named the next Editor-in-Chief of The Wall Street Journal and Dow Jones Newswires, succeeding Matt Murray, who will take on new projects in a senior role at News Corp, reporting to Chief Executive Robert Thomson.Ms. Tucker will assume her new position February 1, 2023, with Mr. Murray assisting her in the transition until March 1, 2023, when he will begin his new News Corp role.
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| XNCR | Hot Stocks10:31 EST Xencor presents data from Phase 1 study of plamotamab - Xencor announced additional clinical data from expansion cohorts in its Phase 1 study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with relapsed or refractory non-Hodgkin lymphomas. Data will be presented by Krish Patel, M.D., Director of the Lymphoma Program at Swedish Cancer Institute, in a poster session today from 6:00 p.m. to 8:00 p.m. CST at the 64th American Society of Hematology Annual Meeting in New Orleans, Louisiana. At data cut off on August 24, 2022, 44 patients with relapsed or refractory non-Hodgkin lymphoma had been enrolled before June 30, 2022 and received the recommended dose. Patients had a median age of 69 years and had received a median of 4 prior therapies. At baseline, 86% had advanced stage III or IV disease. Additionally, 50% of patients received CAR-T as a prior therapy. The primary disease at enrollment for these patients was diffuse large B-cell lymphoma, high-grade B-cell lymphoma, follicular lymphoma, and other lymphoma. The safety profile of plamotamab was consistent with previous results. The most common Grade 3 or 4 treatment-emergent adverse events across all patients were neutropenia, anemia and lymphopenia. Grade 3 immune effector cell-associated neurotoxicity syndrome was observed in one patient. AEs leading to plamotamab discontinuation occurred in nine patients, including four patients who discontinued due to COVID-19. Cytokine release syndrome, the most common AE, was observed in 70.5% of patients, and no patients experienced Grade 3 or 4 CRS. The efficacy analysis included both evaluable and intent-to-treat patient populations. Responses were assessed based on the Lugano Classification. In the efficacy evaluable population of patients with DLBCL or HGBCL, the overall response rate was 52.0%, and the complete response rate was 24.0%. For patients who received prior CAR-T therapy, the ORR was 50.0%, and the CR rate was 25.0%. In the ITT population, the ORR was 43.8%, and the complete response rate was 18.8%. The median duration of response for both populations was 126 days. In the efficacy evaluable population of patients with FL, the ORR was 87.5%, and the CR rate was 50.0%. In the ITT population, the ORR was 80.0%, and the CR rate was 40.0% . The mDOR for both populations had not been reached. An analysis of the plamotamab exposure-response relationship from the dose-escalation portion of the Phase 1 study examined IL-6 levels, CRS incidence, high-grade AEs and overall response. First-dose CRS was related to maximum plamotamab concentration. The probability of CRS with step-up dosing, however, was better modeled using the magnitude of the step-up increment, as measured by the ratio of Cmax after dosing to the concentration prior to that dosing. Once the target dose was reached, there was no relationship of exposure to high-grade CRS. This analysis indicates the potential for a wide therapeutic window at the target dose and provides guidance for improving dosing regimens in future clinical studies of plamotamab.
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| JNJ | Hot Stocks10:29 EST Janssen announces new analyses from Phase 3 MAIA study of Darzalex - The Janssen Pharmaceutical Companies of Johnson & Johnson announced new analyses from the Phase 3 MAIA study of Darzalex in combination with lenalidomide and dexamethasone, evaluating progression-free survival, or PFS, minimal residual disease, or MRD, negativity and overall response rate, or ORR, at a median follow-up of 64.5 months, and overall survival, or OS, at a median follow-up of 73.6 months in newly diagnosed, transplant-ineligible patients with multiple myeloma, regardless of patients' age and across clinically important subgroups, as well as health-related quality of life among frail TIE patients. These findings, presented in oral and poster presentations at the American Society of Hematology 2022 Annual Meeting, "strengthen previous data from the MAIA study across clinically relevant study endpoints and patient populations," the company stated.
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| GILD | Hot Stocks10:28 EST Kite announces three-year follow-up data from Yescarta therapy - Kite announced three-year follow-up data from the pivotal ZUMA-5 study for Yescarta in relapsed or refractory indolent non-Hodgkin lymphoma, showing continued response in 52% of all enrolled patients, and prolonged duration of progression-free survival in the Phase 2 study, presented at the 2022 American Society of Hematology Annual Meeting & Exposition. In addition, two-year follow-up data from the ZUMA-1 safety cohort evaluating use of prophylactic corticosteroids in patients with r/r large B-cell lymphoma were also presented. ZUMA-5 is a Phase 2, multi-center, single-arm study of Yescarta in patients with iNHL including follicular lymphoma and marginal zone lymphoma. Yescarta received accelerated approval from the U.S. Food and Drug Administration for the treatment of adult patients with r/r FL after two or more lines of systemic therapy in March 2021 and was approved in the European Union for the treatment of adult patients with r/r FL after three or more lines of therapy earlier this year. Yescarta is not approved anywhere in the world for MZL. 3-Year Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: In the ZUMA-5 study, Yescarta demonstrated continued durable responses in all patients with a median follow-up of 40.5 months.At the time of data cut-off, the overall response rate was 90% and the CR rate was 75% among all patients. Patients with FL had an ORR of 94% and patients with MZL had an ORR of 77%. Among all patients, median duration of response was 38.6 months, median DoR was not reached in patients with a CR, and median progression-free survival was 40.2 months. Compared to findings from the study's two-year analysis, both ORR and CR rates were similar; medians for PFS had increased in MZL and remained unchanged in FL. Since the two-year analysis, no new safety signals were observed and 10 additional patients died due to the following reasons: progression, adverse events and other causes. Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma: 2-Year Follow-Up of ZUMA-1 Cohort 6L A new analysis of the ZUMA-1 safety management cohort of patients with r/r LBCL evaluating the longer-term impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab showed that the toxicity management strategy demonstrated improved long-term safety without compromising durability of response or survival in patients treated with Yescarta. Patients in the cohort received dexamethasone 10 mg orally on the day of Yescarta infusion and each of the two following days. At the time of data cut-off, the median follow-up was 26.9 months (range, 24.0-30.1). The ORR was 95% (80% CR), which was consistent with results at the one-year analysis. Median DoR was 25.9 months (95% CI; 7.8-not estimable) and median PFS was 26.8 months (95% CI; 8.7-not estimable). No Grade greater than or equal to3 cytokine release syndrome (CRS) was observed. Grade greater than or equal to3 neurologic events increased to 18% at two years. The median time to onset of any grade CRS was five days with a median duration of four days. Two new neurologic events were observed (one Grade 2 dementia unrelated to Yescarta, one Yescarta-related leukoencephalopathy that was fatal). Median time to onset of any grade neurologic event was unchanged from the one-year analysis (6 days), and the median duration was similar (19.0 days vs 18.5 days, respectively). All patients in the cohort had treatment-emergent adverse events (TEAEs), including Grade greater than or equal to3 events. The most common Grade greater than or equal to3 TEAEs were neutropenia (80%), leukopenia (40%) and thrombocytopenia (28%).
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| GILD | Hot Stocks10:24 EST Kite announces findings from followup of ZUMA-2, ZUMA-3 studies - Kite, a Gilead Company, announced findings from follow-up analyses of two pivotal studies of the CAR T-cell therapy Tecartus. A comparison of two-year follow-up from ZUMA-3 and SCHOLAR-3, a retrospective historical control study, evaluating Tecartus versus standard of care in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia, was presented in a poster session at the 2022 American Society of Hematology Annual Meeting & Exposition on December 10 and simultaneously published in the Journal of Hematology & Oncology. An additional exploratory analysis on patient and product characteristics associated with long-term response from the three-year follow-up of the Phase 2 ZUMA-2 study of Tecartus in patients with R/R mantle cell lymphoma was also presented in a poster session on December 12. Finally, a comparison analysis of ZUMA-2 and SCHOLAR-2, a retrospective historical control study, evaluating Tecartus vs. SOC in adult patients with R/R MCL, was presented in a poster session on December 12. Outcomes From the Historical Control Study SCHOLAR-3 Contextualizing Updated ZUMA-3 Results of Brexucabtagene Autoleucel in Adult Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. A propensity score matching analysis comparing follow-up from the ZUMA-3 study to matched patients from the SCHOLAR-3 external control cohort of historical clinical trials, balanced for patient characteristics demonstrated that Tecartus had superior overall survival versus SOC regardless of prior therapies In the historical clinical trials, median OS was less than six months versus greater than25 months among matched patients in ZUMA-3. In those patients who were previously naive to blinatumomab and inotuzumab, comparisons for complete remission and CR with incomplete hematological recovery at 24 weeks were also conducted. CR/CRi rates among those treated with Tecartus in ZUMA-3 were more than two times those treated with SOC Assessment of Durable Responses After Brexucabtagene Autoleucel in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell Lymphoma: A separate exploratory analysis of ZUMA-2 was designed to identify factors associated with long-term response to Tecartus in adults with R/R MCL, comparing patients who remained in ongoing response at 24 months and those who had relapsed. Patients had received a median of three prior therapies, including ibrutinib as last prior therapy and acalabrutinib as last prior therapy, with a median time from last prior therapy of 63.0 and 64.5 months, respectively. A smaller proportion of ongoing responders compared with relapsed responders received bridging therapy and prior platinum therapy. Similar proportions of patients in each group had received prior bendamustine therapy, prior proteosome inhibitor therap, and prior autologous stem cell transplant . At baseline, a greater proportion of ongoing responders had an ECOG score of 0 compared to relapsed responders and the incidence of high-risk features was similar between the two groups. Levels of CAR T-cells were approximately double in ongoing versus relapsed responders. A Comparison of Overall Survival with Brexucabtagene Autoleucel CAR T-Cell Therapy and Standard of Care in Patients with Relapsed/Refractory Mantle Cell Lymphoma Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor/ In a separate presentation, results from an indirect treatment comparison study assessing individual patient data from ZUMA-2 and the retrospective, observational, SCHOLAR-2 study, further support long-term efficacy of Tecartus in adults with R/R MCL. The study investigated the comparative efficacy of brexucabtagene autoleucel versus SOC in patients with R/R MCL who had previously been treated with Bruton Tyrosine Kinase Inhibitor therapy using three different statistical methods to adjust for imbalances between the non-randomized studied populations. These data suggested improved OS for patients treated with brexucabtagene autoleucel versus SOC, in which the median OS was 46.6 months versus 14.2, HR 0.38, inverse probability weighting adjusted, respectively.
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| SGEN | Hot Stocks10:19 EST Seagen announces results from Phase 2 trial of ADCETRIS - Seagen announced results from two parts of a phase 2 trial evaluating ADCETRIS in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine for the frontline treatment of patients with classical Hodgkin lymphoma. Part B of the trial evaluated patients with advanced-stage disease and was presented as an oral presentation, and Part C evaluated patients with early-stage disease and was presented as a poster at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans. Results demonstrated a complete response rate of 88% and an overall response rate of 93% in patients with advanced-stage disease and a CR rate of 92% and an ORR of 95% in patients with early-stage disease. The data showed that the combination was well-tolerated, with no new safety signals observed. Part B Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Advanced Stage Classic Hodgkin Lymphoma: Part B of SGN35-027 is evaluating the novel ADCETRIS combination in 57 patients with advanced-stage cHL. Results showed: An 88% CR rate and 93% ORR at the end of treatment.The estimated 12-month progression-free survival rate was 95%. The most frequently reported treatment-related treatment-emergent adverse events occurring in more than 40% of patients were nausea at 65%, fatigue at 47% and peripheral sensory neuropathy at 44%. Peripheral sensory neuropathy was primarily low grade, and no patients discontinued due to peripheral sensory neuropathy. Part C Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Early-Stage Classic Hodgkin Lymphoma. Part C of SGN35-027 is evaluating the novel ADCETRIS combination in 125 patients with early-stage cHL. Of 125 patients in the study, 76 were included at the time of efficacy assessment. Results showed: A 92% CR rate and a 95% ORR at end of treatment. Follow up is ongoing and PFS results are not yet available. The most frequently reported treatment-related TEAEs occurring in more than 30% of patients were nausea at 68%, peripheral sensory neuropathy at 42%, and fatigue at 38%/ Peripheral sensory neuropathy was primarily low grade, and no patients discontinued due to peripheral sensory neuropathy
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| RCKT | Hot Stocks10:15 EST Rocket Pharmaceuticals presents clinical data from LV-based gene therapy program - Rocket Pharmaceuticals announces positive clinical data from its lentiviral (LV)-based gene therapy programs at the 64th American Society of Hematology Annual Meeting, taking place in New Orleans, Louisiana, from December 10-13. Lentiviral-mediated Gene Therapy for Patients with Fanconi Anemia: : Updated Results from Global RP-L102 Clinical Trials The poster presentation includes positive updated data from the ongoing Phase 2 pivotal trial of RP-L102, Rocket's ex vivo lentiviral gene therapy candidate for Fanconi Anemia. RP-L102 conferred phenotypic correction in at least six of 10 evaluable patients with greater than or equal to12 months of follow-up as demonstrated by increased resistance to mitomycin-C in bone marrow-derived colony forming cells, concomitant genetic correction and hematologic stabilization. A seventh patient has displayed evidence of progressively increasing genetic correction as demonstrated by peripheral blood and BM vector copy numbers, with recent development of MMC resistance and indicators of hematologic stability after 36 months of follow-up. The primary endpoint has been achieved, based on a trial protocol in which statistical and clinical significance requires a minimum of five patients to attain increased MMC resistance at least 10% above baseline at two or more timepoints and concomitant evidence of genetic correction and clinical stabilization. The safety profile of RP-L102 has been highly favorable, and the treatment, administered without any cytotoxic conditioning, has been well tolerated. No signs of bone marrow dysplasia, clonal dominance or insertional mutagenesis related to RP-L102 have been observed. As previously disclosed, one patient experienced a Grade 2 transient infusion-related reaction, which resolved; one patient with confirmed engraftment developed a T-cell lymphoblastic lymphoma that was conclusively determined by the investigator, sponsor and the independent data monitoring committee to be related to FA ) and unrelated to RP-L102 gene therapy. Based on the positive efficacy and safety data from the Phase 2 pivotal FA trial, Rocket anticipates regulatory filing in the second half of 2023. Lentiviral-mediated Gene Therapy for Adults and Children with Severe Pyruvate Kinase Deficiency: Results from an Ongoing Global Phase 1 Study The poster presentation includes positive updated data from two adult patients with significant anemia who were treated with RP-L301, Rocket's ex vivo lentiviral gene therapy candidate for Pyruvate Kinase Deficiency. At 24 months post-infusion, both patients have robust and sustained efficacy demonstrated by normalized hemoglobin, improved hemolysis parameters, independence from red blood cell transfusions and improved quality of life both reported anecdotally and as documented via formal quality of life assessments. The safety profile appears highly favorable, with no RP-L301-related serious adverse events through 24 months post-infusion in both adult patients. Insertion site analyses in peripheral blood and bone marrow in both adult patients up to 12 months post-RP-L301 demonstrated highly polyclonal patterns and there has been no evidence of insertional mutagenesis. Adult and pediatric enrollment is completed in the Phase 1 study. Phase 2 pivotal trial initiation is anticipated in 2023. Interim Results from an Ongoing Phase 1/2 Study of Lentiviral-mediated Ex-vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I: The poster presentation includes previously disclosed top-line data at three to 24 months of follow-up after RP-L201 infusion for all patients and overall survival data for seven patients at 12 months or longer after infusion. RP-L201 is Rocket's ex vivo lentiviral gene therapy candidate for severe Leukocyte Adhesion Deficiency-I. Observed 100% overall survival at 12 months post-infusion via Kaplan Meier estimate and a statistically significant reduction in all hospitalizations, infection- and inflammatory-related hospitalizations and prolonged hospitalizations for all nine LAD-I patients with three to 24 months of available follow-up. Data also shows evidence of resolution of LAD-I-related skin rash and restoration of wound repair capabilities. The safety profile of RP-L201 has been highly favorable in all patients with no RP-L201-related serious adverse events to date. Adverse events related to other study procedures, including busulfan conditioning, have been previously disclosed and consistent with the safety profiles of those agents and procedures. Based on the positive efficacy and safety data from the Phase 2 pivotal LAD-I trial, Rocket has initiated discussions with the FDA and anticipates regulatory filing in the first half of 2023.
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| ATRA | Hot Stocks10:12 EST Atara presents updated clinical data from Phase 3 trial of tab-cel - Atara Biotherapeutics announced updated interim analysis and safety results from its Phase 3 multicenter ALLELE study investigating tabelecleucel for the treatment of relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease following solid organ transplant or hematopoietic cell transplant. The Phase 3 ALLELE study findings, along with updated efficacy and safety data from two single-center, open-label studies as well as a multicenter expanded access program investigating tab-cel including patients with Epstein-Barr virus positive leiomyosarcomas, were featured among four poster presentations at the 64th American Society of Hematology Annual Meeting taking place December 10-13, 2022, in New Orleans. In the ongoing Phase 3 ALLELE study, 43 patients - 14 HCT recipients and 29 SOT recipients - were treated with tab-cel and were included in the analysis. Patients received a median of 2 cycles of tab-cel. The median age of evaluable patients for both SOT and HCT was 48.5 years who had received a median of 1 prior systemic treatments. Responses per clinical and radiographic assessment were measured by independent oncologic response adjudication assessment. Results as of November 2021 data cutoff showed: An objective response rate of 51.2% was observed for both HCT and SOT groups, 51.7% for patients following SOT and 50.0% for HCT patients with a best overall response of Complete Response or Partial Response. The median time to response in all patients was 1.0 month and median duration of response in 22 responders was 23.0 months, with 12/22 responders having a DOR greater than6 months. Median overall survival of 18.4 months in all patients, 16.4 months in SOT and not yet reached in HCT. One-year survival rates were 61.1%, 56.2% in SOT and 70.1% in HCT. Patients responding to tab-cel had longer one-year survival compared to the non-responders, with a one-year survival rate of 84.4% versus 34.8% for non-responders. In addition, Atara presented updated efficacy and safety data investigating the potential of tab-cel in patients with EBV+ LMS who have received at least one therapy. EBV+ LMS is a rare, aggressive, and potentially fatal solid tumor that responds poorly to radiation and chemotherapy. Among 18 patient-treatments, median age was 8.9 years and 44.4% of patients were male Results showed: A clinical benefit rate of 77.8%, and ORR of 22.2% was observed. Median follow-up for all patients was 18.9 months. The estimated median OS was 77.4 months and the median progression-free survival was 12.5 months. Median DOR was 6.2 months with a one-year DOR rate of 37.5%. The one-year survival rate was 86.7% and the estimated two-year survival rate was 78.0%. In both the ALLELE and LMS studies, tab-cel was well tolerated and the safety profile consistent with previous data. There was no evidence of tumor flare reaction, infusion reactions, cytokine release syndrome, transmission of infectious diseases, and no events of graft versus host disease or organ rejection related to tab-cel. In separate posters, Atara also presented the methodology of using T-cell receptor beta sequencing to identify allogeneic cell product clones post-infusion and data confirming the absence of clinical manifestation of immunogenicity following tab-cel administration in patients enrolled in the ALLELE study.
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| TROW | Hot Stocks10:10 EST T. Rowe Price reports preliminary month-end AUM $1.34T - T. Rowe Price Group reported preliminary month-end assets under management of $1.34T as of November 30, 2022. Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $0.7B in November 2022 and $1.4B for the quarter-to-date period ended November 30, 2022. This brings total client transfers for the year-to-date period ended November 30, 2022, to $11.7B. These client transfers include $0.5B, $1.1B, and $8.2B, respectively, transferred to the target date retirement trusts during the November, quarter-to-date, and year-to-date periods.
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| AUTL | Hot Stocks10:04 EST Autolus Therapeutics to present clinical data updates at ASH meeting - Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of three posters with updates from three Phase 1 clinical trials to be presented at the American Society of Hematology Annual Meeting, December 10-13, 2022. Posters to be presented: Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell Malignancies. Summary: In the B-ALL cohort, 7 out of 20 patients were observed to be in ongoing Complete Remission at median follow up of 36 months post-AUTO1 without the need for additional anti-leukemia therapy. Ongoing long-term remissions appear to be associated with CAR-T persistence, which was also observed in these 7 patients at their last follow-up. One patient with a subsequent stem cell transplant also achieved long term remission but lost CAR T persistence after SCT. In the B-cell non-Hodgkin lymphoma/chronic lymphocytic leukemia cohorts, AUTO1 continues to display a favorable tolerability profile with no immune effector cell-associated neurotoxicity syndrome or Grade greater than or equal to 3 cytokine release syndrome across different indications. Of 25 patients with NHL/CLL evaluable for efficacy, the best overall response rate was 23/25. AUTO1 was observed to be well-tolerated and active in diffuse large B-cell lymphoma, with 7 of 8 patients in ongoing CR at last follow-up. In CLL, 4 of 5 treated patients achieved undetectable minimal residual disease in the bone marrow, ongoing at last follow-up. While no relapses were seen in DLBCL patients, late CD19+ relapses were seen in follicular lymphoma, and ongoing CAR-T persistence appears to be important. Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL: Summary: AUTO1/22 demonstrated a strong level of activity with 83% MRD negative complete remissions and a favorable tolerability profile in a very challenging patient population. AUTO1/22 showed excellent expansion, with a median 7.5 months duration of persistence of CD22 CAR. No antigen negative relapse was seen in responding patients. At a median follow up of 8.7 months, five of 10 responding patients were in MRD negative complete response with two after further therapy for early loss of CAR T persistence. Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR T-Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma: Summary: Having shown proof of concept at EHA in June 2022, AUTO4 treatment for peripheral T-cell Lymphoma continues to be observed to be well tolerated with no dose-limiting toxicities. Ongoing responses at 9- and 12-months post-dosing at the highest dose tested are encouraging, and suggests a potential clinical benefit for patients. No CAR T cell expansion was observed in peripheral blood, but CAR T cells were detected in an on-treatment lymph node biopsy. Optimization of the AUTO4 manufacturing process has been performed, resulting in a product candidate with a more naive and central memory phenotype. The study is ongoing, with additional patients due to be treated to define the recommended Phase 2 dose.
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| TAL | Hot Stocks10:00 EST TAL Education falls -14.2% - TAL Education is down -14.2%, or -94c to $5.67.
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| BAMR | Hot Stocks10:00 EST Brookfield Asset Management Reinsurance falls -18.1% - Brookfield Asset Management Reinsurance is down -18.1%, or -$7.82 to $35.36.
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| AMAM | Hot Stocks10:00 EST Ambrx Biopharma falls -26.2% - Ambrx Biopharma is down -26.2%, or -$1.19 to $3.35.
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| BVH | Hot Stocks10:00 EST Bluegreen Vacations rises 12.0% - Bluegreen Vacations is up 12.0%, or $2.61 to $24.35.
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| MSC | Hot Stocks10:00 EST Studio City rises 18.5% - Studio City is up 18.5%, or 87c to $5.56.
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| WEBR | Hot Stocks10:00 EST Weber rises 23.3% - Weber is up 23.3%, or $1.52 to $8.02.
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| UTI | Hot Stocks09:47 EST Universal Technical falls -10.6% - Universal Technical is down -10.6%, or -76c to $6.39.
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| BAMR | Hot Stocks09:47 EST Brookfield Asset Management Reinsurance falls -16.6% - Brookfield Asset Management Reinsurance is down -16.6%, or -$7.18 to $36.00.
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| AMAM | Hot Stocks09:47 EST Ambrx Biopharma falls -26.7% - Ambrx Biopharma is down -26.7%, or -$1.21 to $3.33.
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| MSC | Hot Stocks09:47 EST Studio City rises 10.2% - Studio City is up 10.2%, or 48c to $5.17.
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| BVH | Hot Stocks09:47 EST Bluegreen Vacations rises 11.0% - Bluegreen Vacations is up 11.0%, or $2.39 to $24.13.
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| WEBR | Hot Stocks09:47 EST Weber rises 23.1% - Weber is up 23.1%, or $1.50 to $8.00.
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| UTI | Hot Stocks09:40 EST Universal Technical trading resumes
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| JNPR DTEGY | Hot Stocks09:39 EST Juniper selected as preferred technology partner for Deutsche Telekom's SD-X - Juniper Networks (JNPR) announced that it has been selected by Deutsche Telekom (DTEGY) as the first network technology partner for Magenta Business Networks SD-X. By leveraging the Juniper AI-driven Enterprise solution, DT's innovative new universal managed services platform will power exceptional user experiences with simplified zero touch deployments, proactive self-driving automation, connected security and unique client-to-cloud insight.
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| KURA | Hot Stocks09:37 EST Kura Oncology trading resumes
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| KURA | Hot Stocks09:32 EST Kura Oncology trading halted, volatility trading pause
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| UTI | Hot Stocks09:32 EST Universal Technical trading halted, volatility trading pause
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| FBMS | Hot Stocks09:32 EST First Bancshares receives regulatory approval for Heritage merger - First Bancshares and Heritage Southeast Bancorporation announced First Bancshares has received regulatory approval from the Board of Governors of the Federal Reserve System to complete its previously announced merger with Heritage pursuant to the agreement and plan of merger, dated July 27 by and between First Bancshares and Heritage. First Bancshares has also received a non-objection letter from the Mississippi Department of Banking and Consumer Finance in connection with the transaction. Completion of the merger remains subject to a 15-day waiting period and the satisfaction or waiver of other customary closing conditions, including the approval of the shareholders of each of First Bancshares and HSBI. Assuming such conditions are satisfied, the closing is expected to occur as soon as practicable in early January 2023. Upon completion of the transaction, the combined company is expected to have approximately $8B in assets, $7B in deposits, $5B in loans, and over 100 branches across five states in the Southeast.
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| SCTL | Hot Stocks09:30 EST Societal CDMO announces pricing of $35.6M concurrent public offerings - Societal CDMO announced that it has priced its concurrent underwritten public offerings of 27,841,737 shares of its common stock at a price to the public of $1.10 per common share and (ii) 450,000 shares of its Series A convertible preferred stock, which will be convertible into 4,500,000 shares of its common stock, at a price to the public of $11.0 per Series A share. The gross proceeds of the offerings are expected to be approximately $35.6 million, prior to deducting the underwriting discounts and estimated offering expenses. The offerings are expected to close on or about December 14, 2022, subject to customary closing conditions. Societal intends to use the net proceeds from the proposed offerings for the repayment of its outstanding debt facility with Athyrium and associated costs to satisfy closing conditions for a capital structure refinancing, including a sale-leaseback transaction in connection with its facility in Gainesville, Georgia and a new 3-year Term A Loan debt facility with Royal Bank of Canada. Societal intends to use the net proceeds from the proposed offerings, together with proceeds from the new Term A Loan and the sale-leaseback transaction, to repay in full and retire the outstanding debt facility with Athyrium, with any remaining proceeds to be used for general corporate and working capital purposes. RBC Capital Markets is acting as sole book-running manager for the offerings.
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| VENA | Hot Stocks09:29 EST Venus Acquisition Corp trading halted, news pending
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| DSX | Hot Stocks09:29 EST Diana Shipping announces direct continuation of time charter contract - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has extended the time charter contract with SwissMarine Pte Ltd., Singapore, for one of its Post-Panamax dry bulk vessels, the m/v Alcmene. The gross charter rate is US$13,000 per day, minus a 5% commission paid to third parties, for a period until minimum January 10, 2024 up to maximum March 25, 2024. The new charter period is expected to commence on December 27, 2022. The "Alcmene" is a 93,193 dwt Post-Panamax dry bulk vessel built in 2010. The employment of "Alcmene" is anticipated to generate approximately US$4.86 million of gross revenue for the minimum scheduled period of the time charter.
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| PRTC | Hot Stocks09:24 EST PureTech Health presents new data on clinical potential of LYT-200 - PureTech Health shared new data supporting the clinical potential of LYT-200, a fully human monoclonal antibody, or mAb, designed to inhibit the activity of galectin-9, as a therapeutic agent for the treatment of leukemia. The data were shared in a scientific poster presented at the American Society of Hematology, or ASH, 64th Annual Meeting. LYT-200 is a therapeutic candidate targeting galectin-9, which is expressed by tumors and immune cells and plays a key role in cancer treatment resistance. It is also in development as a treatment for a range of cancer indications with otherwise poor survival rates. The ASH poster evaluates galectin-9 expression and the effects of LYT-200 in multiple types of leukemia. Compared to healthy human peripheral blood mononuclear cells, where galectin-9 surface expression was low or absent, galectin-9 was highly expressed on the surface of all human blood cancer cells tested. Notably, surface expression of galectin-9 often exceeded that of the known inhibitory checkpoint proteins TIM-3 and PD-1. In all models used, LYT-200 demonstrated significant anti-tumor activity and in addition to its established effects on the immune system in solid tumor models, it also notably induced direct apoptosis or cell death across all leukemia cell types. In a model assessing DNA damage in AML cells, LYT-200 significantly outperformed an anti-TIM3 antibody and had effects that were comparable to Venetoclax, an approved therapeutic for AML. The effects were greatest when both compounds were combined. The in vitro efficacy of LYT-200 against the leukemia subtypes also extended to in vivo survival benefit in both immunocompromised and immunocompetent patient-derived xenograft mouse models. In these models, LYT-200 outperformed chemotherapy and produced the greatest effect in combination. Collectively, these new data support galectin-9 as a strong potential therapeutic target for a range of cancers. Based on this and other preclinical data generated with LYT-200 in blood cancers, PureTech has initiated a clinical trial to evaluate LYT-200 as a single agent for the treatment of AML with results expected in 2023. PureTech has also completed the bi-monthly and weekly, monotherapy dose escalation portion of the Phase 1 program assessing the safety and tolerability of escalating doses of LYT-200 as a potential treatment of metastatic solid tumors. No dose-limiting toxicities were reported, and the full results will be presented in an upcoming scientific forum. The combination part of the Phase 1 trial in certain metastatic solid tumors with LYT-200 in combination with tislelizumab is expected to begin in the first quarter of 2023.
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| ATA | Hot Stocks09:21 EST Americas Technology Acquisition Corp trading halted, news pending
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| CLPT | Hot Stocks09:18 EST ClearPoint Neuro announces first patient enrolled in trial using Prism system - ClearPoint Neuro announced enrollment of the first patient in a Glioblastoma clinical trial using the ClearPoint PrismNeuro Laser Therapy System at Skundefinedne University Hospital in Lund, Sweden. The Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions study, sponsored by Clinical Laserthermia Systems ABis a single-center, single-arm, prospective clinical trial evaluating the safety and feasibility of using the minimally invasive MR-guided laser therapy system to ablate tumor in up to five Glioblastoma patients. The SUS Lund team is also currently utilizing the ClearPoint Neuro Navigation platform for standard of care procedures, including tumor biopsy and guiding implantation of deep brain stimulation electrodes to target. ClearPoint Neuro has exclusive global rights to commercialize the ClearPoint Prism Neuro Laser Therapy System from CLS for neuro applications. The system comprises a clinical solution combining the ClearPoint navigation platform, the laser technology from CLS, and a thermal ablation monitoring software called Thermoguide from Image Guided Therapy. In September of this year, CLS received FDA clearance for the ClearPoint Prism Neuro Laser Therapy System. Data from this trial will be utilized by CLS to secure CE Mark in Europe.
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| RCEL | Hot Stocks09:17 EST Avita Medical submits PMA supplement application for RECELL System - AVITA Medical announced the submission of a Premarket Approval supplement application to the U.S. Food and Drug Administration for the company's RECELL System. The supplement, if approved, will expand the indication of RECELL to include soft tissue repair.This PMA supplement includes the recently released results of the pivotal trial for soft tissue repair. The study met both co-primary endpoints, demonstrating that RECELL is statistically significant in donor sparing and statistically non-inferior in healing outcomes. For purposes of the clinical study, soft tissue injuries included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease. The RECELL System earned FDA Breakthrough Device designation for its proposed soft tissue repair indication. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. The standard FDA review timeline for label expansion through a PMA supplement is 180 days. This PMA supplement application follows the original PMA approval of the RECELL System in September 2018.
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| GMGI | Hot Stocks09:15 EST Golden Matrix enters distribution agreement with Elray Resources - Golden Matrix Group entered into an Exclusive Distribution agreement with Elray Resources Inc. wherein it will have the exclusive rights to supply all gaming content to Elray Resources' clients. Elray Resources, trading as Elray Gaming, will launch its B2B Online Crypto Casino systems and technology together with content provided by Golden Matrix that will be utilized by Crypto Casino gaming operators.
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| ALBT | Hot Stocks09:14 EST Avalon proposes new board composition, discontinues China operations - Avalon GloboCare reminds investors to vote in the upcoming annual meeting, which includes a new proposed Board composition to reflect its continued U.S. focus and planned acquisition of Laboratory Services MSO, LLC. On November 14, as part of its 10Q filing with the Securities and Exchange Commission, the Company disclosed its decision to cease all operations in the People's Republic of China with the exception of a small administrative office and a non-operating, patent holding entity. The upcoming 2022 Annual Meeting of Stockholders will be held on December 29, 2022, at 11:00 a.m. Eastern Time. Avalon's stockholders at the close of business on the record date of November 15, 2022 are encouraged to vote their shares as soon as possible before 9 AM Eastern Time on December 28, 2022. Stockholders can exercise their votes online, via telephone or by mail. The proposals are as follows: To elect the six director nominees named in the Proxy Statement to hold office until the next annual meeting of stockholders and until their successors are duly elected and qualified; To ratify the appointment of Marcum LLP as the Company's independent auditors for the fiscal year ending December 31, 2022; and To act on such other matters as may properly come before the meeting or any adjournment thereof.
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| NNDM | Hot Stocks09:11 EST Nano Dimension announces purchase order from European army - Nano Dimension received a purchase order from a European army, for a DragonFly IV, an Additive Manufacturing Electronics 3D-printer.
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| IPG | Hot Stocks09:10 EST Interpublic Group's Huge launches Huge Moves platform - Interpublic Group creative growth acceleration company Huge announced the launch of Huge Moves, a digital news platform and magazine. The company said, "Created for today's most influential business leaders, Huge Moves sets a new standard for branded content and operates with complete editorial independence from Huge's core business. It is led by editor-in-chief Jennifer Leigh Parker, an award-winning journalist with deep expertise in enterprise reporting from her previous positions at NBC Universal, Bloomberg Media, and Surface Magazine. The inaugural issue features bylines from a seasoned team of journalists who have contributed to top-tier publications including The New York Times, The Wall Street Journal, Financial Times, and Monocle Magazine."
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| ESALY BIIB | Hot Stocks09:10 EST Frontage partners with Eisai, Biogen to complete the Clarity AD study - Frontage's Bioanalytical team partnered with Eisai (ESALY) / Biogen (BIIB) to support the PK and PD biomarker bioanalysis of lecanemab in their investigational global phase 3 study in US and China. Recently Eisai/Biogen publicly shared the favorable results of the lecanemab Clarity AD study which Eisai presented on November 29, 2022, at the Clinical Trials on Alzheimer's Disease Congress, and published the findings in NEJM. The Frontage team developed and validated the LC-MS-based PK method back in 2010 and provided bioanalytical support to this program from clinical Phase 1 to the late phase trial. Frontage's scientific team also provided biomarker analysis for this Phase 3 study and met the very aggressive timelines of data lock. "Here at Frontage, we also celebrated this news because it's a powerful reminder of the reason we are in this field-to work towards combating disease and positively improving the lives of others. We are very proud to have worked closely with our Eisai partners to support the bioanalysis of lecanemab (BAN2401) in this large global phase 3 study. We are extremely proud to be a part of the team and hope to contribute to the unmet medical needs of patients with Alzheimer's disease," announces John Lin, Frontage's EVP and Global Head, Bioanalytical and Biologics Services.
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| GNUS | Hot Stocks09:09 EST Genius Brands, Blue Origin, SMAC to produce 'Blue Origin Space Rangers' series - Genius Brands, Blue Origin, and SMAC Productions announced plans to develop and produce Blue Origin Space Rangers, an epic animated space adventure series for kids and families, designed to inspire the next generation for the benefit of Earth. The series will star a diverse group of global youth and include appearances by Michael Strahan and Blue Origin founder Jeff Bezos. Mainframe Studios, an affiliate of Genius Brands, will produce the animation.
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| ALSMY | Hot Stocks09:08 EST Alstom signs development agreement with Actasys - Actasys announced they have entered into a development agreement with Alstom to implement their innovative, energy-efficient thermal management devices into Alstom train control and monitoring systems for functionality enhancement and oversight assurance. Relevant systems include robust standard electronic modules and modern communications technologies that Alstom provides as scalable solutions to its customers. Of the cooperation, Actasys CEO Miles Flamenbaum noted, "Joining forces with Alstom to protect the performance of their train control and monitoring system is a natural synergy for Actasys. Our thermal management devices resolve a critical need for the sensitive electric-powered technologies Alstom develops, which will play a significant role in the sustainable transportation and mobility strategies of the future."
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| ISUN | Hot Stocks09:08 EST iSun wins $3.1M new solar contract in Vermont - iSun announced that it was awarded a $3.1M contract to implement solar energy solutions in Middlebury, Vermont. New award of 6.5 MW will add to iSun's already completed 257.1 MW of projects in Vermont $3.1M new contract highlights iSun's continued leadership in advancing the implementation of solar energy "We are very pleased by our continued progress in securing awards for solar projects throughout New England, with the latest win in Middlebury, Vermont," said Jeffrey Peck, Chairman and Chief Executive Officer of iSun. "This demonstrates the continued strong customer demand for solar energy in our markets, and the success of our team in cultivating long-term customer relationships for iSun. The transition to clean energy remains the most important initiative of our generation and we are proud to assist more communities in achieving alternative energy solutions."
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| OSCR | Hot Stocks09:08 EST Oscar Health to temporarily stop accepting new members in the state of Florida - Oscar Health announced that based on strong open enrollment performance to date, it will temporarily stop accepting new members in the state of Florida, beginning December 13 at 12:00 a.m. EST. Individuals seeking Oscar coverage in Florida can continue to enroll without limitation until that time. Current Oscar members in Florida who are seeking plan renewal for 2023 will not be impacted. They can renew their plan for 2023 throughout the remainder of open enrollment through the exchange or their broker. Any new Oscar member in Florida that has enrolled in Oscar for 2023 prior to December 13 at 12:00 a.m. EST will not be impacted. Oscar remains steadfast in the Florida market and intends to continue to provide coverage throughout 2023 and beyond. As disclosed in Oscar's Q3 Form 10-Q, the company proactively engaged regulators, as a result of the changing market dynamics following market exits by certain carriers, regarding options to manage its membership growth. Prior to open enrollment, the company requested that regulators limit its membership growth in Florida so that total membership across all markets would be within its previously announced target range of 1M members, +/-10%. This limit will allow the company's projected membership not to exceed the company's targets for 2023 and maintain its strong financial position.
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| AIM | Hot Stocks09:06 EST AIM ImmunoTech appoints Christopher McAleer as scientific officer - AIM ImmunoTech announced the promotion of Christopher McAleer, Ph.D., from Deputy Scientific Officer to Scientific Officer.
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| CELC | Hot Stocks09:05 EST Celcuity closes $100M private placement - Celcuity announced the closing of its private placement, resulting in gross proceeds of approximately $100 million, before deducting placement agent fees and other expenses. The closing follows dosage of the first patient in Celcuity's Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib, Celcuity's lead therapeutic candidate. As a result of the closing, Celcuity will be eligible to draw on a $20 million tranche of a term loan under the terms of a $75 million debt facility, as amended in August this year. The proceeds from the private placement, combined with the debt facility and the company's current cash, cash equivalents and marketable securities, are expected to be sufficient to fund the company's current operating plan through 2025. Celcuity intends to use the net proceeds from the private placement, together with its existing cash and investments, for working capital and general corporate purposes. The private placement was led by Venrock Healthcare Capital Partners with participation from Commodore Capital, New Enterprise Associates, RA Capital Management, Soleus Capital and Brian Sullivan, the company's Chief Executive Officer and Co-Founder. Pursuant to a Securities Purchase Agreement dated May 15, 2022, investors purchased shares of the company's common stock and preferred stock at a price per share of $5.75. For each share of common stock and each 1/10 of a share of preferred stock purchased, investors received a warrant exercisable for 0.40 shares of common stock. The exercise price of the warrants is at a 40% premium to the price paid by investors for the initial shares of common stock purchased in the private placement. Subject to certain limitations such as beneficial ownership, the preferred stock and warrants are convertible into common stock at the holder's election. Jefferies LLC acted as the sole placement agent for the private placement.
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| AJG | Hot Stocks09:04 EST Arthur J. Gallagher acquires Mahowald Insurance - Arthur J. Gallagher & Co. announced the acquisition of Mahowald Insurance. Terms of the transaction were not disclosed. "Mahowald has an outstanding reputation as a fourth-generation broker whose health care market expertise will enhance our capabilities in the region," said J. Patrick Gallagher, Jr., Chairman, President and CEO. "I am very pleased to welcome Mahowald to Gallagher."
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| BTCY | Hot Stocks09:04 EST Biotricity files 501(k) submission for new form factor of Biotres device - Biotricity announced that it made a 510(k) submission to the U.S. Food and Drug Administration for a new form factor of its Biotres Cardiac Monitoring Device, a three lead device for ECG and arrhythmia monitoring that is intended for lower risk patients. Dr. Waqaas Al-Siddiq, Biotricity Founder and CEO commented, "We believe this variation of Biotres is an important step to having an expanded product portfolio with maximum variety for the $5B holter monitoring market."
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| WULF | Hot Stocks09:04 EST TeraWulf increases expected Q1 self mining has rate - TeraWulf announced that it has successfully restructured its previously announced purchase agreement with Bitmain Technologies, enabling the company to significantly expand its self-mining capacity and fully utilize 160 MW of its available mining capacity expected in Q1 2023. The company also announced that it has raised new capital to repay the convertible promissory note with YA II PN, in full and expects to simultaneously issue a notice to Yorkville to terminate the accompanying standby equity purchase agreement, or SEPA. In connection with the recent modifications to the company's purchase agreement with Bitmain, the parties have agreed to cancel TeraWulf's December batch of approximately 3,000 S19 XP Pro bitcoin mining machines and, together with the application of remaining unused deposits with Bitmain, replace that batch with approximately 14,000 S19j Pro miners for delivery in Q1 2023 at no additional cost to the company. With the incremental delivery of 8,200 miners, the company is increasing its estimated Q1 2023 self-mining target to 44,450 owned miners deployed from its prior estimate of 36,250 owned miners. Additionally, the revised Bitmain agreement should enable the company to fully utilize its 110 MW of mining capacity at the Lake Mariner facility and 50 MW of net mining capacity at the Nautilus Cryptomine facility, both of which are expected to be fully energized in Q1 2023. The company also announced that it has raised approximately $10M of new capital comprised of a $6.7M registered direct offering of common stock in addition to the previous issuance of $3.4M of convertible promissory notes to some of its largest shareholders in a transaction exempt from registration under the Securities Act of 1933, as amended. The company intends to use the aggregate net proceeds to repay the Advance with Yorkville and simultaneously issue a notice to Yorkville to terminate the accompanying SEPA entered into on June 2, and for other general corporate purposes.
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| FXLV | Hot Stocks09:03 EST F45 Training announces new partnership with BioSteel Sports - BioSteel Sports Nutrition and global fitness franchisor F45 Training announced a new partnership naming BioSteel the exclusive hydration partner for F45 fitness studios globally. Through the partnership, BioSteel will introduce its Clean. Healthy. Hydration. products to F45 members directly in-studio, where a zero-sugar hydration routine can help get the most out of a workout. "Our goal at F45 is to change people's lives with effective, fun and community-driven workouts that allow people to have fun and feel great, and we wanted to find a hydration partner who shared our commitment to providing high-quality fitness," said Brian Killingsworth, Chief Marketing Officer at F45. "With its commitment to providing the most trusted sports hydration products to pro-athletes, next generation of athletes and anyone who needs to stay hydrated to perform their best, BioSteel is the perfect partner for us, and we are excited for F45 studios to feature BioSteel products to the F45 member community. We believe BioSteel hydration products will help F45 members reach their fullest potential."
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| RCRT | Hot Stocks09:02 EST Recruiter.com partners with Multiplier - Recruiter.com Group announced a partnership and client relationship with Multiplier, a global employment platform designed to make international employment, payroll, compliance, and benefits an easy and risk-free process.
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| MFC | Hot Stocks09:02 EST Manulife Financial announces pledge to 1t.org - Manulife announced a pledge to 1t.org to accelerate and scale nature-based solutions in an effort to mitigate climate change. Through its partnership with the World Economic Forum's Trillion Trees initiative, Manulife is making the commitment to accelerate a sustainable future with tangible results by 2027. Efforts will strive to accelerate the pace of innovation around amplifying the carbon removal benefits of forests while aiming to solve investor needs and will take shape in the form of a partnership to share knowledge, tools, and experience, and support of local communities, nature, and biodiversity. "As a global life insurer and asset manager, and one of the world's largest timberland and farmland investment managers, we understand the connection between our environment and human health. We are well-positioned to provide and manage investments in nature-based solutions to advance climate change mitigation and are thrilled to build on our partnership with the World Economic Forum to do just that," said Sarah Chapman, Chief Sustainability Officer, Manulife.
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| APGI | Hot Stocks09:01 EST American Power Group reports 2022 revenue $3.5M vs. $2.7M last year - Chuck Coppa, APG's CEO/CFO stated, "Unaudited net revenue for fiscal year ended September 30, 2022, increased by $848,000 or 32 percent to $3,531,000 as compared to $2,683,000 for the fiscal year ended September 30, 2021. Our gross margin improved to 48 percent as compared to last year's 39 percent primarily due to increased revenue and a $130,000 reduction in non-cash capitalized software amortization during fiscal 2022. Our penetration into the oil/gas fracking market over the past several years has been the primary revenue driver with the fiscal 2022 revenue increase attributable to follow-on orders from our lead dealer/installer. We currently have $4+ million of outstanding stationary conversion quotes spread among several of our dealers/installers. Our unaudited net income after income taxes was $289,000 for the fiscal year ended September 30, 2022 as compared to an unaudited net loss after taxes of $302,000 for the fiscal year ended September 30, 2021. The results for fiscal year ended September 30, 2022 and 2021, include other income of $158,000 and $154,000, respectively, associated with the forgiveness of our Small Business Administration's Paycheck Protection Program loans.We continue our efforts to strengthen our balance sheet and have reduced our overall corporate debt over the past 24 months by approximately $6.7 million, including $2.0 million of long-term debt and the conversion of approximately $4.7 million of convertible debt and accrued interest, in the aggregate, at $0.25 per share. We anticipate filing our Fiscal 2022 Annual Report with the OTC Markets prior to the end of December 2022 and do not anticipate any material changes in our results as noted above."
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| APVO | Hot Stocks09:00 EST Aptevo Therapeutics announces data from Phase 1b trial of APVO436 - Aptevo Therapeutics announced that APVO436, in combination with venetoclax and azacitidine, achieved a 100% clinical benefit rate in venetoclax treatment naive AML patients. The data, which was presented in a poster session at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans, also showed that APVO436, when given in combination with this standard-of-care regimen, was observed to be generally safe and well tolerated. Aptevo plans to initiate a Phase 2 trial in the second half of 2023 to further evaluate APVO436 in combination with venetoclax and azacitidine among frontline and relapsed/refractory AML patients who are venetoclax treatment naive. In the Phase 1b trial cohort 2, a total of 16 response-evaluable patients received the combination therapy of venetoclax and azacitidine with APVO436 and 75% experienced clinical benefit. 100% of patients in this cohort who had not received venetoclax previously, experienced clinical benefit; a favorable outcome with respect to a variety of response categories including CR, CRi and MLFS. The combination of venetoclax and azacitidine with APVO436 in venetoclax treatment naive response-evaluable patients in cohort 2 outperformed a composite benchmark across all clinical benefit categories. Aptevo's ongoing Phase 1b expansion trial in both combination and monotherapy, will enroll adult patients with AML, at different disease stages, into five different cohorts of up to approximately 18 patients each. Current results are being reported for combination cohorts 1 and 2, and monotherapy cohorts 3 and 5. Trial enrollment for cohort 3 is ongoing while enrollment for cohorts 1 and 2 has finished. Additional data and observations include the following: Clinical activity was observed in both monotherapy and combination cohorts; Monotherapy activity observed in cohort 3; APVO436 Safety: APVO436 has been observed to be generally well tolerated in both combination therapy and monotherapy; CRS was observed in fewer than one-quarter of patients within the safety population and in most cases was mild or moderate and was manageable in the clinic; Side effects were generally manageable and resolved while patients remained on treatment
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| SPCB | Hot Stocks08:58 EST SuperCom regains compliance with Nasdaq minimum bid price requirement - SuperCom announced that it has received notice from The Nasdaq Stock Market that the Company has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2). On December 13, 2021, Nasdaq notified the Company that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market. On December 8, 2022, Nasdaq determined that for the last 10 consecutive business days, from November 23rd through December 7, 2022, the closing bid price of the Company's common stock has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2), and Nasdaq considers this matter now closed.
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| HGBL | Hot Stocks08:58 EST Heritage Global raises FY23 net operating income view to over $10M - Heritage Global announced that it is raising its target for full year net operating income to exceed $10M, increasing its previously stated target of $9M. Heritage Global's CEO Ross Dove commented, "2022 has been a record year for us as a resurgence in consumer spending has driven increased volumes and provided significant traction on both the brokerage and the lending sides of our business. Likewise, our Industrial Assets segment has benefited from strong demand and a robust auction calendar. As we move through the final weeks of 2022, we are optimistic about the market dynamics and opportunities we're seeing, and as a result we are raising our target for full year 2022 net operating income to exceed $10.0 million, which substantially surpasses our best prior annual results of $6.1 million, achieved in 2020. We are energized by our operational execution to date in 2022 and look forward to a strong close to the year."
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| MGAM | Hot Stocks08:57 EST Mobile Global Esports board approves $1M share repurchase program - Mobile Global Esports announced that its Board of Directors has approved a share repurchase program with authorization to purchase from time to time at the direction of the Board, up to $1 million of its common stock. The Share Buyback shall be for the purpose of repurchasing up to $1,000,000 of the Company's common stock traded on the NASDAQ Stock Exchange under the MGAM, pursuant to SEC Rule l0b-18.
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| MEG | Hot Stocks08:56 EST Montrose Environmental acquires Huco Consulting, terms undisclosed - Montrose Environmental announced the acquisition of Huco Consulting. Huco's leadership team, including co-founders Ron Huijsman and Sameer Vyas, will join Montrose's Advisory and Specialty Services business, led by senior VP Mark Hall. Terms of the transaction were not disclosed. Founded in 2008, Huco is a team of EHS & ESG data management system consultants based in North America.
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| MDGIF | Hot Stocks08:56 EST Media and Games Invest to relocate registered office to Sweden - As communicated by way of press release on 1 November 2022, the extraordinary general meeting of the Company has resolved to relocate the Company's registered office from Malta to Sweden. No actions are required from MGI's shareholders in connection with the relocation. All MGI shares will be automatically converted from Maltese to Swedish shares in connection with MGI becoming a Swedish company. Each shareholder will hold the same amount of shares in MGI after the relocation as such shareholder held before the relocation. MGI's shares will continue to be listed on Nasdaq First North Premier Growth Market and the Scale segment of the Frankfurt Stock Exchange however with a new Swedish ISIN SE0018538068. The relocation is expected to be registered by the Swedish Companies Registration Offic on 2 January 2023, following which Euroclear Sweden AB will be the Company's new central securities depository. The anticipated timing of certain corporate actions in connection therewith is set out below. The information and time table set out in this press release are presented solely for information purposes, and as noted above, no actions are required by any shareholders. Friday 30 December 2022: The last day of trading of the Company's shares with the existing Maltese ISIN and the settlement date for trades in the Maltese ISIN. Monday 2 January 2023: Registration of the relocation with the Swedish Companies Registration Office and the first day of trading of the Company's shares with the new Swedish ISIN. Tuesday 3 January 2023: Settlement date for trades of the Company's shares carried out on 30 December 2022 and the record date for automated change from Maltese ISIN to Swedish ISIN. Wednesday 4 January 2023: Swedish ISIN will be credited to shareholders' securities accounts and the Maltese ISIN will be debited from shareholders' securities accounts and settlement date for trades carried out on Monday 2 January 2023. The time table set out above is preliminary and may change due to factors outside the Company's control .
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| RSI | Hot Stocks08:54 EST Rush Street Interactive opens two new offices in Bogota, Medellin - Rush Street Interactive has opened two new offices in Bogota and Medellin to support RSI's continued expansion of its Latin America presence and the growth of the RushBet brand. In the heart of Bogota, RSI has opened a new 8,000-square-foot office to serve as the headquarters for its Latin America operations team.
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| SQFT | Hot Stocks08:54 EST Presidio Property Trust announces Denver lease - Presidio Property Trust announced that it has entered into a lease agreement with Axia Energy II, LLC to occupy 9,928 square feet at its Shea Center II office building in Highlands Ranch, Colorado.
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| GOOD | Hot Stocks08:54 EST Gladstone Commercial board authorizes $20M share repurchase program - Gladstone Commercial announced that its board of directors has authorized a share repurchase program for up to $20,000,000 of each of the Company's 6.625% Series E Cumulative Redeemable Preferred Stock and 6.00% Series G Cumulative Redeemable Preferred Stock. The repurchases are intended to be implemented through open market transactions on U.S. exchanges or in privately negotiated transactions, in accordance with applicable securities laws, and any market purchases will be made during applicable trading window periods or pursuant to any applicable Rule 10b5-1 trading plans. The timing, prices, and sizes of repurchases will depend upon prevailing market prices, general economic and market conditions and other considerations. The authorization expires December 6, 2023 and the repurchase program may be suspended or discontinued at any time and does not obligate the Company to acquire any particular amount of stock.
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| XSHLF | Hot Stocks08:52 EST XS Financial announces $30M upsized capex facility for PharmaCann - XS Financial announced that it has upsized its lease facility with PharmaCann up to $30M.
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| BY | Hot Stocks08:51 EST Byline Bancorp announces new 1.25M share repurchase program - Byline Bancorp announced that its Board of Directors has approved a new stock repurchase program that authorizes the Company to repurchase up to 1.25M shares of the Company's outstanding common stock. The shares authorized to be repurchased represent approximately 3.3% of the Company's currently outstanding common stock. The new program will be effective January 1, 2023 and be in effect until December 31, 2023. Under its existing stock repurchase program expiring on December 31 Byline has purchased 2,139,262 shares of the 2.5M total shares authorized for repurchase.
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| XFOR | Hot Stocks08:51 EST X4 Pharmaceuticals presents on Mavorixafor at ASH 2022 - X4 Pharmaceuticals provided a summary of its chronic neutropenia-related presentations at this year's annual meeting of the American Society of Hematology, taking place December 10-13, 2022 in New Orleans. In an oral presentation entitled "Mavorixafor for Patients With Chronic Neutropenic Disorders: Results From a Phase 1b, Open-Label, Multicenter Study," Julia T. Warren, M.D., Ph.D., Hematologist at Children's Hospital of Philadelphia and Assistant Professor of Pediatrics at the Perlman School of Medicine at the University of Pennsylvania, presented positive data from a Phase 1b clinical trial evaluating the ability of X4's lead clinical candidate, mavorixafor, to increase absolute neutrophil count in people with idiopathic, cyclic, or congenital chronic neutropenia as monotherapy or concurrently with injectable granulocyte colony-stimulating factor. Data analyses continue to show that a single dose of oral mavorixafor effected meaningful increases in ANC across all participants, regardless of disease etiology or use of G-CSF. Mavorixafor was well tolerated overall in the trial. The Phase 1b clinical trial has now been amended and a Phase 2 trial is being initiated by X4 to assess the durability, safety, and tolerability of the chronic use of once-daily, oral mavorixafor in a larger chronic neutropenia patient population. Poster #2407, entitled "Prevalence of Chronic Neutropenic Disorders in the United States: A Retrospective Analysis of a Large Claims Database," estimated that in 2021, between 37,000-48,000 people in the United States were living with a diagnosis of idiopathic, cyclic, or congenital neutropenia. The study was a retrospective analysis designed to project the prevalence of chronic neutropenia disorders based on U.S. claims data for people with a diagnosis code for neutropenia during the calendar years 2018, 2019, and 2021. People diagnosed with chronic idiopathic, cyclic, or congenital neutropenia were identified using the earliest relevant diagnosis claim based on International Classification of Disease 10th Revision, Clinical Modification codes in the calendar year of interest. Poster #3575, entitled "Patient and Health Care Professional Perspectives on Quality of Life and Unmet Needs of People With Chronic Neutropenia: A Survey-Based Assessment," highlighted responses of 100 patients/caregivers and 10 healthcare professionals to a survey on the experiences of people living with chronic neutropenia. Survey results demonstrate the considerable impact of chronic neutropenic disorders on the lives of people diagnosed. Results also describe the potential burdens related to the existing treatment paradigm, injectable G-CSF, and its limitations to improving physical health and quality of life. While patients/caregivers cited fatigue as the most impactful symptom and fatigue reduction as a priority treatment need, HCPs ranked fewer and/or less frequent severe infections requiring hospitalization, how medication is administered, and fewer and/or less frequent long-term side effects as the priority treatment needs.
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| FEMY | Hot Stocks08:49 EST Femasys holds promotional launch of FemCerv - Femasys reported that it held a promotional launch of its diagnostic product, FemCerv, the first endocervical tissue sampler designed to improve tissue quality and quantity at the annual meeting of AAGL, where the product was very well received by gynecologic physicians and surgeons. The annual AAGL meeting gathers laparoscopic surgeons worldwide dedicated to the research and advancement of minimally invasive gynecologic procedures. "During our recent market launch and presentation of FemCerv at AAGL, a major medical meeting of gynecologic surgeons and other related specialists, we were extremely encouraged by the interest expressed related to the product," said Kathy Lee-Sepsick, CEO. "Gynecologic specialists acknowledged the novelty of FemCerv, an endocervical curette that obtains a virtually pain free comprehensive tissue sample when evaluating for cervical cancer. The current process relies on antiquated tools that can be painful and result in an inadequate or contaminated sample, which may lead to unnecessary invasive procedures. We were also extremely pleased to hear positive feedback from gynecologic specialists about FemVue, our first of its kind commercially available diagnostic product for infertility that enables ultrasound evaluation of the fallopian tubes. FemVue works in conjunction with our other approved product, FemCath, a selective catheter, which is expected to be commercially available later this month. By the end of this year, we will offer three commercially available products in our portfolio in addition to our leading clinical development programs, FemaSeed and FemBloc. Our goal is to elevate care and expand options for women with our suite of innovative products like FemVue, FemCerv, and FemCath that may provide meaningful additional incremental revenue in the near-term, while we complete the clinical development programs for FemaSeed and FemBloc."
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| MNTV | Hot Stocks08:49 EST Momentive hires Rich Sullivan as CFO - Momentive announced that Rich Sullivan will join its leadership team effective as chief financial officer. In his new role, Sullivan will oversee all aspects of the company's finance function, including financial strategy, planning and analysis, accounting, tax, treasury, and investor relations.
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| KBNT | Hot Stocks08:48 EST Kubient receives patent for KAI solution - Kubient announced that the United States Patent and Trademark Office had issued its patent for the Company's proprietary ad fraud identification and prevention technology, Kubient Artificial intelligence. The patent provides Kubient with intellectual property protection for KAI from now until 2040.
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| NBN | Hot Stocks08:47 EST Northeast Bank announces commencement of at-the-market offering - Northeast Bank announced that it has entered into an equity distribution agreement with Piper Sandler & Co. for the offer and sale from time to time of shares of its voting common stock having an aggregate offering price of up to $50,000,000.00 in an at-the-market offering. All of the Shares to be sold in the offering will be offered by the Bank. The Bank intends to use the net proceeds from the offering for general corporate purposes, including the support of additional growth. The Shares will be offered through Piper Sandler, as the distribution agent. Sales of the Shares, if any, will be made from time to time in negotiated transactions at market prices prevailing at the time of a sale or at negotiated prices, or as otherwise agreed with Piper Sandler, and, as a result, sale prices may vary. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.
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| QLGN | Hot Stocks08:46 EST Qualigen Therapeutics regains compliance with Nasdaq minimum bid price rule - Qualigen Therapeutics announces that it has received written notice from the Listing Qualifications Department of the Nasdaq Stock Market informing the Company that it has regained compliance with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The letter noted that as a result of the closing bid price of the Company's common stock having been at least $1.00 per share for a minimum of 10 consecutive business days, the Company has regained compliance with Listing Rule 5550(a)(2) and the matter is now closed.
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| HBIO | Hot Stocks08:45 EST Harvard Bioscience CFO Michael Rossi resigns - Harvard Bioscience announced the resignation of Michael Rossi, the Company's CFO and treasurer, effective December 31, 2022. The Company has appointed Jennifer Cote, the Company's vice president of global finance, as its interim CFO and treasurer, effective upon Mr. Rossi's resignation. Mr. Rossi will remain with the Company through May 10, 2023 to provide transition assistance. The Company has initiated a search for a permanent replacement.
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| VZ | Hot Stocks08:43 EST Verizon Public Sector collaborates with Veterans Health Administration's NCCHI - Verizon Public Sector has been collaborating with the Veterans Health Administration's National Center for Collaborative Healthcare Innovation and the Veterans Affairs Palo Alto Health Care System in the development and testing of 5G MEC and drones designed to improve safety and efficiency.From the curation of advanced sensor-enabled drones, to technical integrations, and FAA-compliant pilot training, early work has validated the potential to enhance operations including safety, security and physical infrastructure monitoring. As part of the overall safety initiative, Verizon and VHA are also evaluating the technologies' ability to improve search and rescue performance in situations such as patient elopement.
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| WAVD | Hot Stocks08:42 EST WaveDancer launches new website showcasing Maverix - WaveDancer announced that the Company launched a new website showcasing their commercial, permissioned blockchain-enabled supply chain management platform, Maverix. Organizations are looking to incorporate blockchain into their business transformation efforts for several reasons. Unlike traditional databases, blockchain data can never be reversed or altered. Every piece of data on the blockchain can be visible to all stakeholders, making it a very transparent and trustworthy system.
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| AN | Hot Stocks08:41 EST AutoNation to expand after-sales business with acquisition of RepairSmith - AutoNation announced it has entered into an agreement to acquire RepairSmith, a full-service mobile solution for automotive repair and maintenance, headquartered in Los Angeles, CA with a significant operational footprint in the southern and western United States. The acquisition of RepairSmith will provide AutoNation's After-Sales business with another channel to provide service to existing Customer base and introduce additional vehicle owners who have purchased vehicles outside the AutoNation dealer network. RepairSmith offers Customers the convenience of services and repairs at their home, workplace, or on-site for fleet vehicles. AutoNation will also utilize RepairSmith as a resource for reconditioning and internal services to increase our speed to frontline readiness and expedite vehicle delivery to Customers. The transaction, pursuant to which AutoNation will acquire RepairSmith for $190 million, is expected to close in the first quarter of 2023, subject to customary closing conditions and regulatory approvals.
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| AMTB | Hot Stocks08:41 EST Amerant Bancorp appoints Erin Knight to board of directors - Amerant Bancorp announced the appointment of Erin Knight to its Board of Directors, effective December 15, 2022. Knight is President of Miami-based Monument Capital Management, an A-Rod Corp company.
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| BSFC | Hot Stocks08:40 EST Blue Star Foods' Taste of BC Aquafarms submits aquaculture license application - Blue Star Foods announced that its subsidiary, Taste of BC Aquafarms, submitted an application for an aquaculture license to the Department of Fisheries and Oceans. Taste of BC Aquafarms is seeking approval for a land-based recirculatory aquaculture system salmon farm. The proposed facility in Campbell River, BC will annually produce 1500 metric tons of head on gutted Steelhead Salmon which is equivalent to 13 million meals of sustainably raised salmon. The cutting-edge facility will use Taste of BC's module based recirculating aquaculture system. Construction is anticipated to commence Q2 2023 with an investment of approximately $35 million.
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| NWL | Hot Stocks08:40 EST Newell Brands appoints Mark Erceg as CFO - Newell Brands announced the appointment of Mark Erceg as Chief Financial Officer, effective January 9. Mr. Erceg will succeed Chris Peterson in that capacity and will become a member of the company's Leadership Team. Chris Peterson will fully transition into his role as President, Newell Brands and continue to report to Ravi Saligram, Chief Executive Officer. Mr. Erceg will be based in Atlanta and will report to Chris Peterson. Erceg is a seasoned executive, who brings 30 years of global financial and operational experience to Newell Brands. Most recently he served as Executive Vice President and Chief Financial Officer at Cerner Corporation. Prior to that, Mr. Erceg held CFO positions at Tiffany & Company, Canadian Pacific Railway and Masonite International Corporation. He began his career at Procter & Gamble, where he spent more than 18 years in a variety of roles of increasing responsibility.
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| LWLG | Hot Stocks08:40 EST Lightwave Logic announces issuance of U.S. patent for polymer modulators - Lightwave Logic announced the issuance of a U.S. patent, the application of which was announced in June 2022, on a new invention that will enable simplified foundry-level packaging of polymer modulators using chip scale techniques which can be applied at wafer level, critical for high-volume manufacturing applications. This patent issuance - entitled "Hybrid electro-optic polymer modulator with atomic layer deposition sealant layer" with patent number US 11,506,918 B2 - allows Lightwave Logic's proprietary polymers to be sealed to moisture and atmospheric gases in a very low temperature and quasi-hermetic environment through the use of a chip-scale packaging approach that can be applied in parallel at wafer level and that eliminates the need for a separate hermetic enclosure or "gold box." Dr. Michael Lebby, Chief Executive Officer of Lightwave Logic, commented: "With the issuance of this exciting new patent and our recent acquisition of low temperature ALD processes, we continue to innovate our miniaturized packaging techniques using ALD to align with and surpass customer expectations. Both this patent as well as our recent low temperature ALD processes address the accelerating trend in photonics towards chip scale packaging, similar to what has been used in the silicon electronics industry. Further, the potential future impact of this invention on our foundry partners and associated back-end process development kits has the potential to be a critical feature of our next-generation polymer platform. The timing of this invention coincides well with our work with silicon foundries."
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| GRIL | Hot Stocks08:38 EST Muscle Maker says Sadot posts $54.19M revenue in first 30 days - Muscle Maker announced its new wholly owned subsidiary, Sadot, generated $54.19 million in revenue for the month of November, its first month of operation and management by AGGIA. For the month of November, Sadot completed 26 commodity shipping transactions in seven different countries consisting of various commodities such as food oils, white wheat and soybean meal. On November 18th, Muscle Maker filed a Form 8K with the Securities and Exchange Commission and issued a corresponding press release announcing a new subsidiary, Sadot, and a material agreement between Sadot and AGGIA. AGGIA will manage the day-to-day operations of Sadot, focusing on shipping, trading, sourcing, farming and production of physical commodities. The agreement could eventually lead to a change in the makeup of the Muscle Maker board of directors and result in a significant issuance of common stock to AGGIA. This is a pay for performance agreement where AGGIA can earn shares of Muscle Maker common stock based solely on net income generated. Shares earned are calculated using net income generated divided by a premium share price of $1.5625 per share. AGGIA could earn up to 14,424,275 shares of common stock by generating $22,537,929 of net income into Sadot.
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| IMAX | Hot Stocks08:38 EST Imax names Manwaring as Chief Executive Officer - IMAX China Holding and IMAX Corporation named Daniel Manwaring as Chief Executive Officer of IMAX China, effective January 9, 2023. He succeeds interim CEO Jiande Chen, who will return to his full-time role as Vice Chairman of IMAX China. Manwaring joins IMAX from Creative Artists Agency, where he most recently led CAA China's Motion Picture Group.
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| SMMF | Hot Stocks08:37 EST Summit Financial Group to acquire PSB Holding Corp for $35.00 per share - Summit Financial Group and PSB Holding Corp. announce the signing of a definitive merger agreement between Summit and PSB. Subject to the terms of the merger agreement, PSB shareholders will receive 1.2347 shares of Summit common stock for each outstanding share of PSB common stock. Based upon the 20-day average closing price of $28.35 per share of Summit's common stock through December 8, 2022, this equates to $35.00 per PSB common share and an aggregate transaction value of approximately $53.9 million. As of September 30, 2022, the combined company would have had approximate total assets of $4.5 billion, gross loans of $3.5 billion and deposits of $3.6 billion. The transaction has been approved by each company's board of directors and is expected to close in the second quarter of 2023, pending regulatory approvals and the approval of PSB's shareholders. Following consummation of the merger, PSB's bank subsidiary, Provident State Bank, Inc., will be merged with Summit's bank subsidiary, Summit Community Bank, Inc.
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| DK DKL | Hot Stocks08:36 EST Delek US, Delek Logistics name Zuklic VP of IR, Market Intelligence - Delek US Holdings (DK) and Delek Logistics Partners (DKL) announced that Rosy Zuklic has joined as Vice President, VP, of Investor Relations, IR, and Market Intelligence. In her position, Zuklic will focus on articulating Delek's investment story and managing its strategic relationships with key stakeholders among institutional investors and research analysts. She will be transitioning into the role through the end of the year and assume full engagement with stakeholders at the beginning of 2023. Zuklic joins Delek with more than twenty-five years of experience in the oil and gas industry.
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| BKYI SNX | Hot Stocks08:35 EST BIO-key, TD Synnex partner for identity-bound biometric MFA solutions - BIO-key International, Inc. (BKYI) announced a new partnership with TD SYNNEX Public Sector, part of TD SYNNEX (SNX). The partnership will enable BIO-key to introduce its PortalGuard IAM solution and IBB to government agencies at the federal, state and local levels. With the distribution support provided by TD SYNNEX Public Sector, BIO-key is offering the industry's most secure identity and access management solutions to U.S. public sector organizations, government agencies and contractors.
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| RBB | Hot Stocks08:35 EST RBB Bancorp hires Gary Fan as Chief Administrative Officer - RBB Bancorp and its subsidiary Royal Business Bank , a leading financial institution focused on serving the Asian-American community, is pleased to announce that Gary Fan has joined the Bank as Executive Vice President and Chief Administrative Officer. In this new role, Mr. Fan will oversee marketing and wealth management, and he is expected to manage operations in the New York and Chicago markets. He will also be focused on leading bank-wide initiatives including mergers and acquisitions, digital banking, new products and services, Fintech, and specialty banking.
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| FNB UBNC | Hot Stocks08:34 EST F.N.B. Corporation completes acquisition of UB Bancorp - F.N.B. Corporation (FNB) announced that it successfully completed its acquisition of Greenville, North Carolina-based UB Bancorp (UBNC), including its wholly-owned banking subsidiary, Union Bank. As a result of the acquisition of Union, FNB has nearly $44B in total assets, $29B in total loans and $35B in total deposits on a proforma basis. This merger further increases FNB's presence in North Carolina, moving its proforma deposit market share to ninth in the state,1 and also adds low-cost granular deposits which continue to be value accretive in the current economic environment. "The Union Bank acquisition leverages FNB's current investments in the fast-growing North Carolina markets which now have more than 110 FNB branches and over 300 ATMs while also providing a favorable deposit mix," said Vincent Delie, Jr., Chairman, President and Chief Executive Officer of F.N.B. Corporation. "We are excited to welcome Union Bank's customers and introduce them to a more expansive suite of products and services, such as Insurance, Wealth Management, Private Banking, Treasury Management, Mortgage Banking and Capital Markets and Debt Capital Markets capabilities."
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| FREE | Hot Stocks08:33 EST Whole Earth Brands CEO Albert Manzone steps down - Whole Earth Brands announced that CEO Albert Manzone will step down as CEO and member of the Whole Earth Brands Board of Directors to pursue other business opportunities, effective January 1, 2023. The Board has appointed Michael Franklin to serve as the Company's Interim CEO, effective January 1, 2023. Mr. Franklin currently serves on the Company's Board of Directors. After January 1, 2023, Mr. Manzone will assist the Company and Mr. Franklin in the orderly transition through February 28, 2023. In addition to serving on the Whole Earth Brands Board of Directors since August 2022, Mr. Franklin is currently a Partner at Mariposa Capital.
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| ASTI | Hot Stocks08:33 EST Ascent Solar Technologies hires Paul Warley Jr. as CFO - Ascent Solar Technologies has hired Paul Warley Jr. as its next chief financial officer CFO. Warley comes to Ascent Solar with significant experience in corporate turnarounds, restructuring, cross-border trade and capital advisory.
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| K | Hot Stocks08:33 EST Kellogg announces share repurchase authorization of up to $1.5B - Kellogg announced that its Board of Directors has approved a share repurchase authorization of up to $1.5B, under which the Company may buy back Kellogg shares at its discretion from January 1, 2023, through December 31, 2025. The Company uses buybacks as a way to offset dilution from options exercises and other stock grants, as well as to opportunistically return cash to share owners. Its previous $1.5 billion authorization expires on December 31, 2022.
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| CSLLY ARCT | Hot Stocks08:32 EST CSL announces closing of global collaboration with Arcturus Therapeutics - CSL Limited (CSLLY) announced that its subsidiary, CSL Seqirus, finalized its global collaboration and license agreement with Arcturus Therapeutics (ARCT). The agreement grants access to Arcturus Therapeutics' late-stage self-amplifying mRNA, sa-mRNA, vaccine platform technology, which recently reported results from a large COVID-19 Phase III vaccine efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favorable safety and tolerability profile. The agreement was announced last month and under the terms of the agreement, Arcturus Therapeutics will receive an upfront payment of $200M and will be eligible to receive further payments dependent upon the achievement of certain development and commercial milestones along with royalties/profit sharing on future product sales. "This agreement provides CSL with an opportunity to strengthen and accelerate our goals for the next generation of mRNA vaccines and underscores our commitment to pursuing new and innovative ways of protecting public health," said CSL Chief Operating Officer Paul McKenzie. "This is a significant leap forward with a demonstrated platform that will allow us to further explore influenza-adjacent therapies." Under the agreement, CSL will have the exclusive license to Arcturus' next generation mRNA technology in the fields of influenza, COVID-19 and other respiratory viral diseases, and a non-exclusive license in the multi-pathogen pandemic preparedness field with the right to turn exclusive.
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| RIOCF | Hot Stocks08:31 EST RioCan REIT establishes automatic securities purchase plan - RioCan Real Estate Investment Trust announced that it has established an automatic securities purchase plan in connection with its previously announced normal course issuer bid applicable to its outstanding trust units. The ASPP is intended to allow for the purchase of Units under the NCIB at times when RioCan would ordinarily not be permitted to purchase Units due to regulatory restrictions and customary self-imposed blackout periods. Pursuant to the ASPP, purchases will be made by RioCan's designated broker based on pre-established purchasing parameters, in accordance with the rules of the Toronto Stock Exchange, applicable securities laws and the terms of the ASPP. The ASPP has been pre-cleared by the TSX and will be implemented effective today.
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| ARQT | Hot Stocks08:30 EST Arcutis Biotherapeutics says INTEGUMENT-2 trial met primary, secondary endpoints - Arcutis Biotherapeutics announced topline results from its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 inhibitor, in adults and children 6 years and older with mild to moderate atopic dermatitis. The study met its primary endpoint, with 28.9% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment - Atopic Dermatitis score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline at Week 4, compared to 12.0% of individuals treated with vehicle. Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, including 42.0% of individuals treated with roflumilast cream 0.15% achieving a 75% improvement in Eczema Area and Severity Index at Week 4 compared to 19.7% treated with vehicle. In an additional secondary endpoint, the study evaluated reduction in itch in individuals 12 years of age and older, with 30.2% of individuals treated with roflumilast cream achieving a 4-point reduction in Worst Itch Numeric Scale at Week 4. Roflumilast cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate severity. Overall, incidence of adverse events were low, with no adverse event occurring in more than 3.5% of subjects in either arm. The most frequent adverse events in the roflumilast arm included headache, nausea, vomiting, diarrhea, and upper respiratory tract infection. Over 90% of patients who were randomized to roflumilast cream in the study completed the full four weeks, and there were few discontinuations due to adverse events.
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| CRBU | Hot Stocks08:28 EST Caribou Biosciences reports CB-010 ANTLER Phase 1 trial progress - Caribou Biosciences reported new 12-month clinical data from cohort 1 in the ongoing ANTLER Phase 1 trial, which show long-term durability following a single infusion of CB-010 at the initial dose level 1. Cohort 1 results show: 6 of 6 patients achieved a complete response as best response; 3 of 6 patients maintained a durable CR at 6 months; 2 of 6 patients maintain a long-term CR at the 12 month scan and remain on the trial; 18 months is the longest CR maintained to date in ANTLER, achieved by the first patient dosed with CB-010; CB-010 was generally well tolerated with adverse events consistent with autologous or allogeneic anti-CD19 CAR-T cell therapies; Based on promising initial data, the U.S. Food and Drug Administration granted CB-010 both Regenerative Medicine Advanced Therapy and Fast Track designations. In addition, Caribou has observed an encouraging safety profile for CB-010 at dose level 2 with no dose-limiting toxicities in the 3 patients treated and is currently enrolling patients at dose level 3. Caribou expects to provide an ANTLER trial update in 2023. ANTLER is a Phase 1, open-label, multicenter clinical trial evaluating the safety and efficacy of the company's lead allogeneic cell therapy, CB-010, in patients with r/r B-NHL. The trial includes Part A, a 3+3 dose escalation phase designed to evaluate safety of CB-010 at multiple dose levels and establish the recommended Phase 2 dose, and Part B, a dose expansion phase with the primary objective to determine tumor response after a single dose of CB-010. As permitted by the protocol, backfilling patients has begun at doses deemed well tolerated to increase the understanding of CB-010's safety profile and antitumor activity and provide additional data for establishing a recommended Phase 2 dose.
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| XWEL | Hot Stocks08:25 EST Xwell expects to generate $25M in incremental revenue by 2025 - XWELL issued a Letter to Shareholders from Scott Milford, XWELL's CEO, which read in part, " As CEO, I am writing you today to share an update on the efforts we're making to prepare our business for sustainable profitability in the near-term and thereafter. I am acutely aware of the Company's current valuation-which we believe is undervalued, and we are focused on creating and maximizing long-term shareholder value while providing innovative wellness products and services to our customers. To that end, I will share the strategies and tactics we intend to execute toward achieving our collective goals and objectives...In total, our efforts have saved the business $5.4 million on an annualized basis and are expected to generate approximately $25 million in incremental revenue by 2025. We're moving forward as a leaner, more focused business and believe these efforts along with a continued focus on leveraging additional revenue opportunities will result in a sustainable and profitable business and one that is on the path to deliver $100 million in revenue by 2026. Wellness is a $1.5 trillion industry, and we fully intend to take advantage of the continued growth of this sector as we pivot our business. Once again, we will not hesitate to take the necessary steps and make the tough decisions for the continued growth of our business. We will continue to invest our available capital on revenue and profit accretive efforts. And while we recognize that our efforts in 2023 require capital investment, we are thoughtful in our approach to how each dollar is being utilized. You have my commitment and that of the Company's management that our hands are firmly on the wheel steering the business toward improved growth and sustainable profitability."
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| GSK | Hot Stocks08:24 EST GSK announces new global headquarters in central London - GSK announced that its new global headquarters will be in central London. The company will move to the new headquarters in 2024 from its current location in Brentford, West London. The site, which is under construction and scheduled for completion next year, was selected by the company following a comprehensive search of potential new HQ sites across London. Emma Walmsley, CEO, GSK said: "Our new headquarters represents an important next step for GSK. As a global biopharma company, we are proud to call London our home and look forward to the opportunities for even closer collaboration with the city's world-class science, academic and healthcare institutions."
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| BKR | Hot Stocks08:23 EST Baker Hughes added to the Nasdaq-100 Index - Baker Hughes "announced it has been added to the Nasdaq-100(R) Index, the top 100 largest domestic and international non-financial companies on The Nasdaq based on market capitalization. Nasdaq announced the inclusion on Friday, Dec. 9, which will become effective prior to market open on Monday, Dec. 19."
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| VIVO | Hot Stocks08:21 EST Meridian Bioscience announces anticipated closing date of pending merger - Meridian Bioscience announced that it has entered into a side letter with the buyer, setting the closing date of Meridian's pending merger for January 31, 2023. As previously disclosed, on July 7, 2022, Meridian, entered into an Agreement and Plan of Merger with SD Biosensor, Columbus Holding Company, and Madeira Acquisition, a direct wholly owned subsidiary of Parent. On December 9, 2022, Meridian and the Parent Parties, entered into a letter agreement, modifying the Merger Agreement. In the Letter Agreement, Meridian and the Parent Parties agreed that all of the conditions to the Parent Parties' obligations to complete the Merger set forth in the Merger Agreement are satisfied, provided that the Company is required to comply with certain covenants in the Merger Agreement through the completion of the Merger. Meridian and the Parent Parties also agreed to consummate the Merger on January 31, 2023 and to waive their right to terminate the Merger Agreement if the Merger has not been consummated by 11:59 p.m. Eastern Time on January 6, 2023. In agreeing to consummate the Merger on January 31, 2023, the board of directors of Meridian determined that it is in the best interest of Meridian's shareholders to provide the Parent Parties additional time to consummate the Merger in order to finalize their financing.
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| DARE | Hot Stocks08:20 EST Dare Bioscience announces new DARE-PDM1 development program - Dare Bioscience announced a new development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug, in a novel way. Dare's new investigational product, DARE-PDM1, will deliver diclofenac vaginally via the Company's proprietary hydrogel technology. A Phase 1 study of DARE-PDM1 is targeted for 2023. Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product. Following clinical development, Dare intends to leverage the existing safety and efficacy data for diclofenac to utilize the U.S. Food and Drug Administration's 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the U.S. "Calendar 2022 has been an incredibly successful year for our portfolio in terms of: 1) expanding our portfolio with additional differentiated product candidates that we believe further our leadership as an accelerator of innovative products in women's health; 2) securing a global commercialization collaboration for our first FDA-approved product, XACIATO vaginal gel, 2%, a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older, which is the second commercial collaboration agreement for our portfolio; and 3) demonstrating clinical success and advancing regulatory and clinical development to enable important 2023 milestones," said Sabrina Martucci Johnson, President and CEO of Dare Bioscience.
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| SMLR | Hot Stocks08:19 EST Semler Scientific announces an up to $5M investment in Monarch Medical - Semler Scientific announced an up to $5M investment in privately-held Monarch Medical Technologies through the purchase of a senior secured convertible promissory note. Repayment of the note is secured by a first priority interest in all of Monarch's assets. Monarch is a digital health company whose proprietary EndoTool Glucose Management System offers a technology-enabled approach to inpatient glycemic management. "We are excited to add a second company in the diabetes management space to our network," said Doug Murphy-Chutorian, M.D., chief executive officer of Semler Scientific. "We believe Monarch has a superior software solution to address customers' concerns about nursing shortages and new CMS quality measures for hypoglycemia and hyperglycemia in the inpatient setting."
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| BMEA | Hot Stocks08:18 EST Biomea Fusion presents preclinical data on BMF-500 at ASH meeting - Biomea Fusion presented preclinical data or BMF-500, an investigational covalent FLT3 inhibitor, at the 64th American Society of Hematology Annual Meeting. BMF-500, a novel, orally bioavailable, highly potent and selective covalent small molecule inhibitor of FLT3, was discovered and developed in-house at Biomea using the company's proprietary FUSION System and designed to have a therapeutic profile to allow for combinations with standard of care and/or novel targeted agents like BMF-219, Biomea's investigational covalent menin inhibitor. The company is on track to submit an investigational new drug application for BMF-500 in the first half of 2023 and, subject to successful IND clearance, plans to initiate clinical trials evaluating BMF-500 as a single agent and in novel combinations shortly thereafter. The data presented at the ASH conference showed that in FLT3-driven AML cell lines, three-hour exposure to BMF-500 produced complete phospho-FLT3 inhibition, which was maintained following washout of the compound. The commercially available reversible FLT3 inhibitor gilteritinib required 16 times higher concentration than BMF-500 and continuous exposure for 96 hours to produce the same effect. The covalent small molecule inhibitor BMF-500 exhibited potent inhibition of FLT3 receptor kinase and marked cell killing in FLT3-ITD AML cell lines, as demonstrated by IC90s at physiologically relevant doses. In addition, the kinase profile of BMF-500 revealed high target selectivity and selective cytotoxicity profile against a panel of non-target cancer cell lines suggesting the potential for minimal off-target liabilities. As part of the poster presentation, Biomea also presented the results of two preclinical animal xenograft models in which BMF-500 demonstrated antitumor activity with sustained tumor regression and improved survival while being well tolerated, with body weight maintenance across treatment groups.
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| DBCCF | Hot Stocks08:18 EST Decibel Cannabis announces results of general meeting of shareholders - Decibel Cannabis Company announces the results of its annual general meeting of shareholders held on December 9, 2022. Decibel's shareholders approved all matters submitted by the Company for consideration at the Meeting. At the Meeting, Decibel's shareholders: (i) fixed the number of directors of the Company to be elected at the Meeting at five directors; (ii) elected each of Shawn Dym, Manjit Minhas, Nadia Vattovaz, Jakob Ripshtein, and Paul Wilson to serve as directors of the Company; and (iii) appointed KPMG LLP, Chartered Professional Accountants, as the Company's auditors and authorized their remuneration, as such, be fixed by the board of directors. Subsequent to the Meeting, Dym has been appointed and agreed to serve as the Company's Chairman, and each of Nadia Vattovaz and Jakob Ripshtein have been appointed and agreed to serve, respectively, as chair of the Company's Audit Committee and of its Governance, Compensation and Nominating Committee.
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| VRE | Hot Stocks08:17 EST Veris Residential releases letter sent to Kushner Companies - Veris Residential announced that its Board of Directors is releasing a letter it sent to Kushner Companies in the spirit of transparency and to ensure that all Veris Residential shareholders have equal access to important information regarding the Company. In its letter, the Board details its unanimous rejection of each of Kushner Companies' latest unsolicited proposals to acquire Veris Residential, as well as a go-forward process to facilitate constructive dialogue between Veris Residential and Kushner Companies. The Board also reiterates its willingness to evaluate any proposals from any interested buyers that will maximize the value of Veris Residential's shares to the benefit of all Veris Residential shareholders.
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| IMMX | Hot Stocks08:17 EST Immix Biopharma releases, ships scaled-up batches of IMX-110 - Immix Biopharma announced that it has completed release testing and shipped Good Manufacturing Practice process manufactured batches of IMX-110 for clinical trial patient dosing. IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 clinical trials: IMX-110 monotherapy and combination IMX-110 + BeiGene/Novartis anti-PD-1 tislelizumab clinical trial in advanced solid tumors.
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| CLNN | Hot Stocks08:16 EST Clene closes $5M debt facility from State of Maryland - Clene announced the closing of a $5 million debt facility with the Maryland Department of Housing and Community Development. The State Small Business Credit Initiative program within DHCD sourced the funds for the Loan from the U.S. Department of Treasury. All conditions related to the Loan were satisfied by Clene. The Loan bears interest at a rate of 6% per annum and has a maturity date 60 months from the first day of the second full month following the date the Loan closes.
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| ACMR | Hot Stocks08:15 EST ACM Research introduces Ultra Pmax PECVD tool - ACM Research announced the introduction of its Ultra Pmax Plasma-Enhanced Chemical Vapor Deposition tool, marking ACM's entry into another major new product category. ACM expects to ship its first PECVD evaluation tool to a China-based customer in the next few weeks.
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| INSE PDYPY | Hot Stocks08:14 EST Inspired Entertainment signs long-term agreement with Paddy Power - Inspired Entertainment (INSE) announced a new exclusive long-term contract with Paddy Power, a UK-based bookmaker that owns and operates over 350 betting shops in the UK and is a central brand within Flutter Entertainment (PDYPY). As part of this agreement, Inspired will exclusively provide Paddy Power with fully integrated managed services for its entire UK estate of approximately 1,400 terminals, including installation, remote and field technology support, as well as content and platform deployment. "Paddy Power does an exceptional job operating its UK betting shop estate, which tends to contain premium locations, and we are thrilled to partner with such a premier provider," said Brooks Pierce, President and Chief Operating Officer of Inspired. "We have a great relationship with Paddy Power and this agreement, including the provision of our new Vantage terminal, improves their product offering and drives revenue growth, while also reducing operational costs. This is a prime example of how the transformation of our footprint in the UK from a hardware-centric capital-intensive business model to a managed services, content and platform, asset-light model can be mutually beneficial for the evolution of the industry."
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| ACLS | Hot Stocks08:13 EST Axcelis announces multiple shipment of Purion Dragon high current implanters - Axcelis Technologies announced multiple shipments of the Purion Dragon high current implanter, including a follow-on order and a new customer evaluation to semiconductor manufacturers in Asia for advanced memory and advanced logic device development and device fabrication. The systems shipped in the fourth quarter of 2022. Executive Vice President, Marketing and Applications, Greg Redinbo, commented, "We're pleased to support our existing customer's fab capacity expansion and are also excited about our new customer evaluation focused on R&D for advanced logic nodes. The Purion Dragon was developed to address chipmakers' most challenging ion implantation applications by delivering the highest levels of process control with significant productivity gains for high current applications. The Purion Dragon features a revolutionary high current implanter architecture, featuring innovative orthogonal beam optics, providing industry leading process control capability, designed to address critical implant steps for advanced memory and logic applications."
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| PVCT | Hot Stocks08:12 EST Provectus decides not to undertake reverse stock split - Provectus decided to not undertake the reverse stock split and authorized share reduction, which Provectus stockholders approved at the Company's 2022 Annual Meeting of Stockholders, by the approved date of December 31, 2022. Ed Pershing, Chair of Provectus' Board said, "The Board assessed the prospective factors that it reasonably believed would be necessary to support the potential successful follow-through from undertaking a reverse stock split, and that could also potentially mitigate negative capital markets behavior. The Board ultimately concluded that it would be in the best interests of the Company's stockholders to not undertake the reverse stock split and authorized share reduction at this time. The Board expects to seek the same authority from the stockholders to undertake these same measures in 2023 at either a special meeting or the annual meeting of Provectus stockholders."
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| MRK | Hot Stocks08:12 EST PharmAbcine announces collaboration agreement with Merck - PharmAbcine announced that the Company has entered into a clinical collaboration agreement with MSD, Merck & Co., Inc., Rahway, NJ., to initiate a Phase I combination trial of PMC-309, a novel anti-VISTA antibody, in combination with KEYTRUDA, MSD's anti-PD-1 therapy. Under the terms of the agreement, PharmAbcine will sponsor a Phase I study in Australia to evaluate the safety and clinical efficacy of the combination therapy for the treatment of multiple advanced solid tumors, and MSD will supply KEYTRUDA. "We are excited to announce another pipeline combination project in collaboration with MSD besides olinvacimab, our lead anti-VEGFR2 antibody, undergoing a Phase II study in combination with KEYTRUDA in mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "In preclinical studies, PMC-309 demonstrated significantly enhanced tumor growth reduction when used with an anti-PD-1 drug in in vivo mouse model compared to both monotherapies of PMC-309 and an anti-PD-1 drug. We look forward to the opportunity to investigate this approach in a clinical setting."
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| ATNM | Hot Stocks08:10 EST Actinium highlights overall survival rates in its Actimab-A CLAG-M trial - Actinium Pharmaceuticals highlighted high rates of Complete Remission and rates of measurable residual disease negativity with improved overall survival in its Actimab-A CLAG-M combination trial in high-risk patients with relapsed or refractory acute myeloid leukemia. These data were detailed in an oral presentation at the 64th Annual ASH Meeting & Symposium being held December 10-13, 2022 in New Orleans, Louisiana. The trial enrolled patients with intermediate and adverse cytogenetics including over 50% with a TP53 mutation and significant prior treatment with a median of 2 lines of therapy and over 57% having prior Venetoclax based therapy. The addition of Actimab-A to CLAG-M was well tolerated with expected toxicities. Dr. Avinash Desai, Actinium's Chief Medical Officer, commented, "As a first-in-class targeted radiotherapy, Actimab-A represents a novel treatment for patients with relapsed or refractory AML. Its differentiated mechanism of action attacks leukemia cells with a radioactive payload that the cancer cells have never been exposed to, which we believe is driving improved outcomes in these heavily pretreated and adverse cytogenetic patients. The high rates and deep remissions evidenced by the 75% measurable residual disease negativity are exciting and support the hypothesis of this combination. We are thrilled to show improved survival, especially in the TP53 mutant and Venetoclax treated patients who have dismal outcomes with expected survival of less than 3 months and few, if any, treatment options. With enrollment of this study complete, we look forward to leveraging the strong survival, MRD negativity and complete remission results to rapidly establish an efficient development and regulatory strategy."
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| NRGV | Hot Stocks08:09 EST NV Energy awards Energy Vault energy storage solution project, no terms - Energy Vault announced that NV Energy, Nevada's largest public utility, has awarded the Company with a project for the deployment of a short duration energy storage solution. The Battery Energy Storage System BESS one of the largest in Nevada, is expected to start construction in Q2 2023 with commercial operation expected by the end of 2023. The 220MW/440MWh grid-tied BESS will be deployed at a site located near Las Vegas. The 2-hour energy storage system is designed to store and dispatch excess renewable energy, including wind and solar power. The BESS will be charged and discharged on a daily basis and designed to dispatch stored renewable energy at peak consumption hours to help meet the high demand during Nevada's peak load hours.
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| CRBU | Hot Stocks08:09 EST Caribou Biosciences selects ROR1 as target for CB-020 - Caribou Biosciences announced target selection for CB-020, an induced pluripotent stem cell derived allogeneic anti-ROR 1 CAR-NK cell therapy. Preclinical data on the selection of the CB-020 CAR construct and armoring strategies for Caribou's CAR-NK cell platform will be presented today at the 12th American Association for Cancer Research and Japanese Cancer Association Joint Conference. iPSC-derived NK cells innately exhibit potent antitumor activity against solid tumors. CB-020 is being engineered using Caribou's Cas12a chRDNA genome-editing technology to express a ROR1-specific CAR, which can enhance the innate NK cell antitumor activity by increasing specificity and function. ROR1 is a cell signaling receptor that is overexpressed on the surface of several solid tumor types and has been shown to drive tumor cell growth, survival, and metastasis. Preclinical data to be presented at AACR-JCA show that a single dose of iPSC-derived anti-ROR1 CAR-NK cells, administered in a tumor xenograft model, significantly reduced tumor burden compared to iPSC-derived NK cells without an anti-ROR1 CAR. Multiple armoring strategies are being developed for Caribou's CAR-NK cell platform to enhance tumor targeting, allogeneic CAR-NK cell survival, and persistence of antitumor activity. Results from the company's preclinical studies suggest iPSC-derived NK cells with a knockout of CBLB, a ubiquitin ligase that negatively regulates NK cell function, results in reduced tumor burden and increased overall survival in an in vivo solid tumor xenograft model, compared to unedited iPSC-derived NK cells. Additionally, results show that iPSC-derived NK cells were not killed by donor-derived T cells and NK cells when harboring a knockout of B2M and an insertion of a BM2-HLA-E fusion protein. This strategy may induce more potent NK activity and help prevent CAR-NK cells from killing each other, which is a common problem with NK cell therapies. In addition, results from iPSC-derived NK cells with an insertion of membrane-bound IL-15/IL-15RA fusion protein, which is shown to enhance NK cell antitumor activity, demonstrated high cytotoxicity against tumor cells compared to unedited iPSC-derived NK cells. Together, these preclinical data demonstrate Caribou's genome-editing technology has the potential to be used to implement a variety of armoring strategies in iPSC-derived CAR-NK cells to address many of the challenges associated with treating solid tumors.
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| ADCT | Hot Stocks08:08 EST Freenome presents research on its multiomics platform - Freenome presented research on Saturday at the American Society of Hematology Annual Meeting in New Orleans. Freenome's multiomics platform allows researchers to look across multiple levels of biology to form a comprehensive analysis of signals. Freenome and ADC Therapeutics have been applying this platform to investigate biological signatures associated with response to loncastuximab tesirine, a CD-19-directed antibody drug conjugate developed by ADC Therapeutics that is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after greater than or equal to2 prior lines of therapy. The initial results are part of a larger ongoing collaboration between the companies. The findings presented at ASH show promise in identifying biomarkers associated with response to lonca and also suggested mechanisms of resistance seen in non-responders, which may inform future drug combination research. In addition, the researchers demonstrated that they could combine the cfDNA profiling results with data from routine clinical testing to make better predictions of patient-specific response.
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| VRTX | Hot Stocks08:07 EST FDA clears Vertex IND application for VX-522 to treat CF - Vertex Pharmaceutical announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug IND application for VX-522, a messenger ribonucleic acid mRNA therapy targeted at treating the underlying cause of cystic fibrosis, CF, lung disease for the approximately 5,000 people with CF who cannot benefit from a cystic fibrosis transmembrane conductance regulator CFTR modulator. Vertex plans to initiate a single ascending dose clinical trial for VX-522 in people with CF in the coming weeks. "This partnership brings together Vertex's scientific expertise and decades of experience in developing cystic fibrosis medicines with Moderna's proven leadership in mRNA technologies," said Moderna Chief Executive Officer Stephane Bancel. "Moderna's development of a proprietary inhalable lipid nanoparticle to deliver a functional cystic fibrosis treatment to the lungs could lead to a transformational medical achievement. We are excited by the progress that has been made with the upcoming advancement of VX-522 to the clinic and look forward to our ongoing collaboration to develop treatments for the underlying cause of cystic fibrosis."
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| RGLS | Hot Stocks08:06 EST Regulus announces resignation of board member - Regulus Therapeutics announced that Simos Simeonidis, Ph.D., member of the Board of Directors, has stepped down from the Board, due to the time requirements of his recent appointment as co-Chief Executive Officer and co-Chief Investment Officer at Ally Bridge Group. His resignation was effective December 6, 2022.
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| ENPH | Hot Stocks08:06 EST Enphase Energy expands IQ8 microinveter deployments in Florida - Enphase Energy announced that installers of Enphase products in Florida have seen growing deployments of Enphase Energy Systems powered by IQ8 Microinverters. Residential solar deployments in Florida have grown substantially over the last several years and are expected to reach more than 500 MW by the end of 2022, according to the most recent U.S. Solar Market Insight report from Wood Mackenzie and the Solar Energy Industries Association. Additionally, deployments of residential battery capacity in Florida are expected to grow more than four-fold by the end of 2026, according to the most recent U.S. Energy Storage Monitor report from the Energy Storage Association and Wood Mackenzie.
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| CNI | Hot Stocks08:05 EST CN named to Dow Jones Sustainability World Index - CN announced that it has once again been recognized as a global leader in sustainability through inclusion in Dow Jones Sustainability Indices. Inclusion in the DJSI World Index is reserved for a select group of companies and is based on performance across a variety of sustainability criteria including economic performance, environmental stewardship, social responsibility, and corporate governance.
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| BRAG MGM | Hot Stocks08:04 EST Bragg Gaming launches content, technology with MGM Resorts - Bragg Gaming (BRAG) announced that it has launched its new content and technology with BetMGM (MGM) in Michigan, furthering the company's North American expansion. The company's new content and technology is now live with six iGaming operators across three North American markets. New proprietary content such as Egyptian Magic from Bragg's Atomic Slot Lab studio as well as new exclusive titles from the company's partner studios is now available to BetMGM's customers in the Great Lakes state, following the launch of Bragg's new Remote Games Server technology with the operator.
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| BDTX | Hot Stocks08:04 EST Black Diamond Therapeutics announces spinout of Launchpad Therapeutics - Black Diamond Therapeutics announced the formation of Launchpad Therapeutics, an antibody-focused precision oncology company, together with a $30 million Series A investment by founding investors, Versant Ventures and New Enterprise Associates. In connection with the transaction, Black Diamond contributed undisclosed early discovery-stage antibody programs and granted Launchpad a license to use Black Diamond's Mutation-Allostery-Pharmacology Drug Discovery Engine to discover, develop and commercialize large molecule therapeutics. In exchange, Black Diamond received a minority ownership stake in Launchpad. Launchpad's antibody pipeline will be enabled by Black Diamond's custom-built cloud-based computational MAP Drug Discovery Engine, with a focus on oncogenicity prediction, biological validation, conformation-based drug design and antibody discovery. Launchpad will focus on the development of an initial set of early-stage antibody programs.
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| LNTH | Hot Stocks08:03 EST Lantheus grants rights for use of microbubbles to SonoThera - Lantheus Holdings announced a strategic collaboration with SonoThera. Under the agreement, Lantheus' microbubbles will be used in combination with SonoThera's ultrasound-guided, nonviral, gene therapy platform and treatments. SonoThera plans to combine its nonviral vector gene therapy delivery technology with Lantheus' microbubble in several applications. Microbubble ultrasound enhancing agents have the potential to dramatically improve gene therapy treatments by enhancing the delivery of genetic payloads to tissue. The physical response of microbubbles in an ultrasound field can transiently disrupt biological barriers such as the vasculature and cell membranes, enhancing genetic payload permeability into tissue.
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| ZS | Hot Stocks08:02 EST Women's Tennis Association selects Zscaler Zero Trust Exchange - Zscaler announced the Women's Tennis Association has selected the Zscaler Zero Trust Exchange to protect its users, data, and infrastructure as they move away from legacy castle-and-moat security built on firewalls and VPNs to a cloud-first Zero Trust architecture. As part of this transition, the world leader in women's professional sports will be leveraging Zscaler's platform powered by the world's largest security cloud to secure its hybrid and work-from-anywhere business model.
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| ARWYF | Hot Stocks07:57 EST ARway launches augmented reality wayfinding pilot - ARway Corporation has spatially mapped a 400,000 sq ft mall for a pilot project that is underway, showcasing the Company's breakthrough augmented reality indoor wayfinding solution. If the Pilot is successful it's anticipated that the ARway solution will be rolled out to over a dozen additional malls controlled by this same company.The goals of the pilot are to: Provide a 'digital concierge' to visitors with AR navigation to shops and amenities; Develop a programmatic AR ad service for brands and tenants. Monetize the malls 'air space' with AR banners and promotions, exclusive offers and AR gamification. Collect analytics data, test visitor behaviour and adoption. Develop a robust implementation plan across other shopping malls and stores. ARway's is engaged in a number of substantial pilot project discussions which are expected to be announced shortly. These pilot programs span several countries across the globe and include multiple industries; retail, university campuses, museums, and airports, showcasing ARway's wide range of applications.
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| WT | Hot Stocks07:53 EST WisdomTree reports over $10B of year-to-date net inflows - WisdomTree released monthly metrics for November 2022, including assets under management and flow data by asset class. Key Highlights: WisdomTree amid a nine-quarter net inflow streak; $10 billion of year-to-date net inflows translates into a 14% annualized year-to-date organic growth rate. WisdomTree generated $1.1 billion of net inflows in November with organic growth in 7 of its 8 major product categories and had record-ending global AUM of over $80 billion. U.S. Equity products have generated net inflows in 29 of the prior 30 months, including $283 million in November 2022, a 15% organic growth rate in the period. WisdomTree Prime is currently in its early access phase and available to select users from its waitlist of over 6,500 people.
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| DAKT | Hot Stocks07:51 EST Daktronics: Conditions raise doubt 'over ability to continue as a going concern' - The company said, "In light of the substantial doubt in our ability to continue as a going concern and our related evaluation of the income tax implications of reaching this conclusion, we expect to conclude that the Company's disclosure controls and procedures and internal control over financial reporting were not effective as a result of material weaknesses. Our going concern policy did not contemplate evaluating the income tax implications of reaching a substantial doubt going concern conclusion. In addition, the material weaknesses relate to the untimely internal communication to support the functioning of internal controls and the resulting accounting for income taxes. The Company continues to evaluate its disclosure controls and procedures and internal controls over financial reporting, and its ultimate conclusions on these topics may differ from what the Company currently anticipates."
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| DAKT | Hot Stocks07:49 EST Daktronics implements liquidity enhancement program - CEO Reece Kurtenbach continued, "Our business continues to adapt and recover from the enduring implications of the pandemic. Supply chain disruptions have started to ease and we expect our inventory levels to peak in the third quarter and begin to decline to more normalized levels as order backlog is fulfilled and we reduce purchases. Our teams are focused on improving our cash flow and enhancing our liquidity, which includes: Cash generation focus through proactively completing and fulfilling orders in our $463.1 million backlog, through: Productivity improvements from previous investments in factory capacity expansion and capital equipment and hiring only critical production and service personnel to increase output; Operating margin improvement through pricing actions, product mix adjustments, and prudent management of operating expenses; Re-engineering designs for supply chain resiliency; 'Normalizing' inventory levels as supply chain challenges continue to ease; Aggressive management of working capital; Concentrating capital investments on maximizing asset returns; Obtaining additional sources of liquidity, with the consent of our lead banking partner. In our 54 year history, we have not been faced with the perfect storm that the last two years represent beginning with the immediate implications of the economy shutting down in the spring of 2020, followed by the sudden rebound in activity while supply chains were delayed, snarled and often closed. These times have stressed our liquidity beyond levels that we have ever seen, and our financial resources have not been sufficiently flexible. Our immediate priority is to restore our balance sheet to historical levels of liquidity. We are pursuing avenues to strengthen our financing flexibility by adding liquidity and diversifying our funding sources. Additionally, since last year at this time, we have successfully increased prices and have focused our selling and fulfillment resources on the most profitable opportunities and turning away price-driven business. We have taken steps with the specific goal of improving profitability and cash flow over the coming quarters and beyond as our backlog increasingly contains orders booked using current pricing methodologies. We continue to improve the stability and consistency in our operations to provide increased production and output during these dynamic times of volatile supply chain and tight labor market conditions. These actions include carefully matching our production schedules, inventory, and labor to demand fulfillment. Our completed and planned capital investments will also increase our capacity as we enhance our automation capabilities. As supply chains continue to ease, we are further conserving cash by reducing inventory purchases and lowering inventory levels. We are prudently managing operating costs. We will continue to actively monitor market and supply conditions, adjusting pricing and operations accordingly."
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| NOTV | Hot Stocks07:48 EST Inotiv: Q1 earnings, liquidity could be impacted by Cambodian NHPs - The company said earlier that it has not delivered any Cambodian NHPs held by it in the U.S. since November 16, 2022. If the company is not able to resume such deliveries before the end of the quarter, its sales, earnings and liquidity in the first fiscal quarter ended December 31, 2022, will be negatively impacted. The company is cooperating with the relevant regulators in this matter, and is attempting to obtain additional clarity on the application of the Supplier's issues to the NHPs that the company holds in the U.S., as well as the impacts on the broader industry, research markets, and government agencies which use these research models in the U.S.
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| MICT TMNA | Hot Stocks07:45 EST Tingo launches global commodity platform, export business - MICT, Inc. announced that its wholly- owned subsidiary, Tingo Mobile has launched its global commodity platform and export business in partnership with the Dubai Multi Commodities Centre. Through Tingo Mobile's strong relationships and trade deals with numerous farming co-operatives and associations in Nigeria and Ghana, including with the All Farmers' Association of Nigeria, the Group has secured access to significant quantities of agricultural produce for export, including wheat, millet, cassava, ginger, cashew nuts, cocoa and cotton. In addition to the considerable benefits that Tingo Mobile's members already gain from its Agri-FinTech platforms and products, enabling them to increase crop production yields and reduce post-harvest losses, the DMCC commodity platform is expected to deliver significant further value as members are given direct access to export markets and higher commodity prices. In addition to the launch, the Group has secured its first export contract of many expected over the coming weeks and months, which has a sales value of approximately $65 million. With a considerable number of commodities agreements expected through the DMCC, the total value of export sales is expected to exceed more than one billion dollars in 2023, with continued significant year-on-year growth expected.
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| GTBP FATE | Hot Stocks07:44 EST GT Biopharma, Fate present preclinical data on dual antigen targeting approach - GT Biopharma, Inc. (GTBP) announced the presentation of new preclinical data at the American Society of Hematology's 64th Annual Meeting. The presentation highlights the potential of a novel dual antigen targeting approach for the treatment of acute myeloid leukemia by combining GT Biopharma's Tri-specific Killer Engager with the induced pluripotent stem cell product platform of Fate Therapeutics, Inc. (FATE). The poster presentation titled, "A Novel Dual-Antigen Targeting Approach Enables Off-the-Shelf CAR NK Cells to Effectively Recognize and Eliminate the Heterogeneous Population Associated with AML," showcases the phenotypic and functional properties of multiplexed-engineered, iPSC-derived NK cells incorporating four functional modalities: a chimeric antigen receptor targeting the alpha3 domain of MICA/B; a high-affinity, non-cleavable CD16 Fc receptor; an IL-15 fusion receptor; and a knock-out of CD38. In preclinical models, alpha3 MICA/B iNK cells demonstrated potent anti-leukemic activity against AML cell lines, and the kinetics of cytotoxicity were enhanced in combination with an anti-CD33 TriKE. Conclusions: alpha3 MICA/B iNK cells exhibited antigen-specific activation in vitro as measured by interferon-gamma production and CD107a degranulation across a broad range of solid tumor cell lines. alpha3 MICA/B iNK cells demonstrated robust cytotoxicity in vitro against an array of AML cell lines, including those with proteolytic cleavage of the alpha1 and alpha2 domains of MICA/B, which is a known mechanism of tumor escape from NK cell cytotoxicity. The kinetics of cytotoxicity were enhanced in combination with GTB-3650, a second-generation anti-CD33 TriKE. An analysis of bone marrow aspirates from patients with AML showed high expression of the alpha3 domain, and low expression of the alpha1 and alpha2 domains, of MICA/B, suggesting that the combination of alpha3 MICA/B iNK cells with GTB-3650 may represent a unique dual-antigen targeting approach to improve anti-leukemic activity in patients with AML.
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| LUMO | Hot Stocks07:42 EST Lumos Pharma hosts KOLs on Phase 2 data of LUM-201 - Lumos Pharma hosted two key opinion leaders in the field of pediatric endocrinology on December 6th to review the Company's interim data from two Phase 2 trials evaluating oral LUM-201 in moderate idiopathic Pediatric Growth Hormone Deficiency. Andrew Dauber, MD, MMSc, Chief of Endocrinology, Children's National Hospital, and Fernando Cassorla, MD, Chief of Pediatric Endocrinology, University of Chile, discussed recently released and new interim data from two ongoing OraGrowtH trials. Highlights from Dr. Andrew Dauber's Discussion of Interim Phase 2 OraGrowtH210 Results: LUM-201, an oral growth hormone secretagogue, has a unique mechanism of action, targeting specific receptors on the pituitary and hypothalamus to stimulate the natural pulsatile secretion of growth hormone for moderate idiopathic PGHD patients with an intact pituitary-hypothalamic axis Reviewed the Interim Phase 2 OraGrowtH210 data announced on November 14, 2022. Reiterated that the annualized growth of 8.6 cm/year at 6 months on 1.6 mg/kg/day of LUM-201 met expectations of 8.3-8.5 cm/year annualized growth at 12 months on therapy established across multiple large datasets of moderate idiopathic PGHD patients on daily rhGH. Outsized growth in the trial's control arm of 10 subjects was likely due to imbalances of baseline characteristics in that arm compared to the 31 subjects across the LUM-201 arms and would likely resolve at full enrollment of 80 subjects in the Phase 2 trial and would not likely be repeated in a large Phase 3 trial. Safety and tolerability for LUM-201 appear comparable to rhGH in this study period. Highlights from Dr. Fernando Cassorla's Discussion of Interim PK/PD OraGrowtH212 Results New data: A stimulation dose of 0.8 mg/kg LUM-201 produces a substantial growth hormone response; New data: LUM-201 at 1.6 and 3.2 mg/kg/day produced a substantial increase in height velocity at 6 months versus baseline for all 10 subjects evaluated in the interim analysis of the OraGrowtH212 Trial; New data: Substantial increases in growth hormone area under the curve and IGF-1 levels at 6 months on both doses of LUM-201 compared to baseline were also observed; New baseline data showing age and Height SDS values for OraGrowtH212 was presented which suggest that the 3.2 mg cohort was somewhat more growth hormone deficient than the 1.6 mg cohort, likely explaining the seemingly faster growth seen in the 3.2 mg/kg/day LUM-201 cohort. Drawing from their experience in the clinic, Dr. Dauber and Dr. Cassorla noted the compliance issues with the injectable growth hormone, the only current treatment option for PGHD, supporting the potential for an oral therapeutic like LUM-201 to potentially improve compliance for their moderate idiopathic PGHD patients. Both doctors commented that there were also a number of patients currently not receiving treatment for PGHD because of their aversion to injections. Dr. Dauber and Dr. Cassorla acknowledged that it was likely that an oral therapeutic like LUM-201 would appeal to this latter population, potentially expanding the market for PGHD therapies.
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| MRMD | Hot Stocks07:39 EST Marimed chairman, CEO Robert Fireman passes away - MariMed announced with deep sadness that Chairman, CEO and co-founder Robert Fireman died unexpectedly on December 11, 2022. The Company will provide further information on succession once the Board has had an opportunity to determine the best path forward. Fireman served as CEO of MariMed since 2017 and a member of its Board of Directors since the company's formation.
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| OGN | Hot Stocks07:39 EST Organon announces Kirke Weaver appointed General Counsel - Organon announced that Kirke Weaver has been appointed General Counsel and Corporate Secretary, and will continue as a member of Organon's executive leadership team, effective January 1 . Mr. Weaver was named as the interim head of the Office of General Counsel and Corporate Secretary in July.
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| JUSHF | Hot Stocks07:38 EST Jushi Holdings announces second closing of debt financing - Jushi Holdings announced the second closing of its previously announced private offering of 12% second lien notes and detached warrants to purchase the Company's subordinate voting shares at an exercise price of US$2.086. To date, Jushi has closed on an additional US$3 million for a total of US$72 million in gross cash proceeds, and issued US$72 million aggregate principal amount of Notes and approximately 17 million of warrants to investors in the Notes. The Notes will mature on December 7, 2026, will bear interest of 12.0% per annum, payable in cash quarterly, and will be guaranteed by certain of the Company's direct and indirect domestic subsidiaries and secured by second priority liens on certain assets of the Company and certain of the Company's direct and indirect domestic subsidiaries. In connection with the Offering, the purchasers of the Notes also received four-year Warrants at 50% coverage with an expiry date of December 7, 2026, at an exercise price per share equal to US$2.086. Entities affiliated with Jim Cacioppo, Jushi's Chief Executive Officer, Chairman and Founder, subscribed for US$3.0 million of the Notes, and Denis Arsenault, a significant stockholder of the Company, subscribed for US$14.4 million of the Notes. None of the aforementioned subscribers were involved in pricing or setting the terms of the Offering. Jushi entered into an equipment lease financing facility with XS Financial together with a related equipment funding commitment of up to US$10 million valid through August 2, 2023 subject to the terms and conditions of such facility agreement. Within that commitment and pursuant to such facility agreement, the Company expects to conduct approximately US$2.0 million in sale-leasebacks of certain Company-owned equipment, subject to customary closing conditions. Further, the Company also plans to draw down an additional US$1.9 million on an Arlington, Virginia real estate mortgage facility in the first quarter of 2023.
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| BVXV | Hot Stocks07:37 EST BiondVax regains Nasdaq compliance - BiondVax Pharmaceuticals announces the receipt of formal notifications from the Nasdaq Stock Market that the Company has regained compliance with Nasdaq listing rules regarding minimum stockholders' equity and minimum bid price. The Company previously reported on Sept. 30, 2022, and Nov. 2, 2022, receipt of the respective non-compliance notifications. Nasdaq indicated they have determined, based on the Company's Form 6-K dated Nov. 30, 2022, reporting third-quarter financial results, that the Company once again complies with Listing Rule 5550(b)(1) regarding minimum $2.5 million stockholders' equity. Similarly, Nasdaq communicated to BiondVax that since the minimum bid price has now closed over $1.00 per share for the past ten trading days, the Company once again complies with Listing Rule 5550(a)(2). Thus, Nasdaq has confirmed the Company now complies with Nasdaq Listing Rules and considers the abovementioned non-compliance matters to be closed.
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| SYRS | Hot Stocks07:37 EST Syros trial of tamibarotene/combo for patients supports ongoing evaluation - Syros Pharmaceuticals announced a peer-reviewed publication of results from its completed biomarker-directed Phase 2 trial of tamibarotene in combination with azacitidine in newly diagnosed patients with acute myeloid leukemia who are not eligible for standard intensive chemotherapy. These findings support Syros' ongoing evaluation of tamibarotene for the treatment of AML and myelodysplastic syndrome patients with RARA overexpression. The paper, titled "Targeting RARA Overexpression with Tamibarotene, a Potent and Selective RARa Agonist, is a Novel Approach in AML," was published online in Blood Advances on December 7, 2022 at https://doi.org/10.1182/bloodadvances.2022008806. "We are excited to see a high CR rate and a rapid onset of response in newly diagnosed unfit AML patients with RARA overexpression treated with a combination of tamibarotene plus azacitidine. The biomarker test successfully identified AML patients positive for RARA overexpression who were enriched for response to tamibarotene and azacitidine relative to those patients who were negative for RARA overexpression. This observation further demonstrates that the activity of tamibarotene is dependent on the biology of RARA overexpression. In addition, the combination was generally well tolerated and provides the potential for a novel targeted treatment approach for patients with AML," said Stephane de Botton, M.
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| ORTX | Hot Stocks07:36 EST Orchard Therapeutics announces early results from PoC study of OTL-201 - Orchard Therapeutics announced early clinical findings, including the first neurocognitive results, from its ongoing proof-of-concept study of OTL-201, an investigational hematopoietic stem cell gene therapy being developed for the treatment of mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome type A. The data are being featured as part of an oral presentation at the ongoing 64th American Society of Hematology Annual Meeting & Exposition in New Orleans.The oral presentation at ASH 2022 will showcase the first neurocognitive data for all five patients enrolled in the trial and extend upon previously presented biochemical results. Trial patients were 6 to 24 months of age at the time of administration of OTL-201, and the preliminary results are based on a median follow-up of 1.5 years. Specifically, the biochemical results show the following in all patients: Engraftment is sustained to date, with supraphysiological levels of N-sulphoglucosamine sulphohydrolase enzyme measurable in leukocytes 38- to 91-fold above median normal range at one-month post-treatment. Supraphysiological SGSH levels were also rapidly detected in CD15+ cells, CD3+ cells, and plasma and have been maintained through the last follow-up visit for each patient. SGSH levels in cerebrospinal fluid were within or above normal range by 6-months post-treatment and at the most recent follow-up. Abnormal heparan sulfate levels at baseline were rapidly reduced post-treatment in urine, plasma, as well as CSF, and has continued to be maintained at these levels in all evaluated patients. Early neurocognitive outcomes also indicate that: Since receiving the investigational gene therapy, four out of five patients showed gain of cognitive skills in line with development in healthy children compared to natural history of MPS-IIIA. A marked improvement compared with natural history of the disease was observed in one patient at 18 months of follow up. Three additional patients are currently within the normal development quotient range at 9 to 18 months post-treatment but require longer follow-up to assess outcomes. Gain of cognitive skills is assessed in this study through evidence of speech acquisition, continence and complex play requiring concentration. Treatment with OTL-201 was generally well-tolerated in the initial study population. Of the six serious adverse events reported to date, four were thought to be due to conditioning or leukapheresis and one was related to background disease. One patient had delayed platelet engraftment until day 52 post-treatment likely due to Cytomegalovirus infection around the time of infusion. The lentiviral vector integration profile was consistent with other lentiviral-based HSC gene therapy studies and there has been no indication of insertional oncogenesis and no evidence of clonal dominance due to integration into oncogenes in samples analyzed to date. Five patients aged 6 to 24 months, with a rapidly progressive MPS-IIIA phenotype confirmed by an independent metabolic disease expert, were administered investigational OTL-201 as part of this ongoing PoC trial, sponsored by The University of Manchester, conducted at Royal Manchester Children's Hospital, and funded by Orchard Therapeutics. Primary study objectives include safety, tolerability and peripheral expression of SGSH in total leukocytes at 12 months. Secondary study objectives include overall survival and neurocognition as measured by the Bayley Scales of Infant and Toddler Development or the Kaufman Assessment Battery for Children. The OTL-201 program and this investigator-led clinical trial follow over a decade of development and pre-clinical work by Brian Bigger, Ph.D., professor of cell and gene therapy at UoM. Patients enrolled in the ongoing PoC trial will be followed for a minimum of three years during which time the study investigators will continue to report additional biochemical and clinical outcomes. The OTL-201 program in MPS-IIIA presents multiple development and commercial synergies with Orchard's other neurometabolic programs, and the condition represents a significant medical need given there are no approved therapies and treatment with allogeneic HSC transplant has not been shown to be effective for MPS-IIIA patients.
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| IDEX | Hot Stocks07:35 EST Ideanomics' Energica enters Japanese, Australian markets - Ideanomics announces that its subsidiary Energica has started selling its high-performance electric motorcycles in Japan and Australia. The first batch of motorbikes will arrive in both countries in Q1 2023. Energica electric motorcycles will be sold in Japan, Australia and New Zealand. The first orders arrive in the first quarter of 2023. "Japan is a key market for us. Energica's presence in Japan was sealed in August at the eight-hour Suzuka Circuit where our bikes were acclaimed for their performance during the numerous test laps at this prestigious and world-renowned endurance race," says Livia Cevolini, Energica Motor Company CEO. "Our partnership with Estar & Co., Ltd. in January 2020 has also improved our efforts in developing our Asia-Pacific network." In Australia, Australian Electric Motor Co. has partnered with Energica to offer a premium selection of electric motorcycles in Australia and New Zealand. Last year, motorcycle sales in these two countries hit a 15-year high with more than 100,000 new units sold, which makes these markets lucrative for further EV expansion. Energica has a proven track record of supplying motorcycles to customers across the ASEAN region. Recently, the company partnered with UTOMOCORP to deliver 88 EsseEsse9+ bikes to the Indonesian National Police. Additionally, Ideanomics subsidiary Treeletrik is providing after-sales support to Energica for the ASEAN region and has begun collaborating with Energica on joint sales and marketing strategies. In Europe and Asia Pacific, Energica has added 12 new sales points since the beginning of the fourth quarter totaling 130 Energica dealers and importers worldwide. Year to date, Energica has sold 78% more motorcycles compared to the same time last year. Additionally, Energica already has a substantial backlog of orders for its newest product offering - the Green Tourer Experia.
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| INAB | Hot Stocks07:33 EST In8bio announces new data from ongoing Phase 1 trial of INB-100 - IN8bio announced updated results from the ongoing Phase 1 trial evaluating INB-100, an allogeneic, gamma-delta T cell therapy, in patients with hematologic malignancies undergoing haploidentical stem cell transplantation. The data, featured in a poster presentation at the American Society of Hematology 2022 Annual Meeting and Exposition, demonstrate the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia and other hematologic malignancies. The poster presented at ASH included efficacy and safety data from Cohort 1 of the ongoing study as of the data cutoff of November 11, 2022. As of December 9, 2022, four patients have received the first dose level of INB-100 and remain on study and in remission. Three DL1 patients with at least approximately 18 months and one patient with 3.5 months of follow-up all remain in morphologic complete remission; two patients have remained progression free for more than two years, at 31.9 months and 29.5 months respectively, and a third for nearly a year and a half at 17.8 months. A fourth DL1 patient remains relapse free in CR at 3.5 months and continues to be monitored. Immune system reconstitution through the first 100-days post-treatment demonstrates continued normal function, including observed elevations in T cells, B cells, and gamma-delta T cells. No DLTs, treatment-related greater than or equal to grade 3 adverse events or cytokine release syndrome have been observed. Steroid-responsive cutaneous acute Grade 1/2 graft-versus-host disease has been observed in all patients, with one patient experiencing Grade 2 intestinal GvHD. The most common AEs were constipation, cytomegalovirus reactivation, emesis, fatigue, and hypomagnesaemia, the majority of which were Grade 1/2. Two patients have been enrolled and dosed in Cohort 2, evaluating INB-100 at a dose level of 3 x 106 cells/kg. The Company expects to share additional clinical updates from the Phase 1 study of INB-100 in 2Q 2023.
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| WPC | Hot Stocks07:33 EST W.P. Carey announces Stheeman appointed to board of directors - W. P. Carey announced the appointment of Elisabeth Stheeman to its Board of Directors, effective immediately. Stheeman will serve as a member of both the Investment and Nominating & Corporate Governance Committees. Stheeman is an external member of the Bank of England's Financial Policy Committee and the Bank of England's Financial Market Infrastructure Board. She is also the non-executive chair of Edinburgh Investment Trust.
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| ITMZF | Hot Stocks07:32 EST React Gaming settles remaining obligations to acquire LOOT.BET - React Gaming Group entered into a debt settlement and release agreement dated December 9, 2022, to settle the debts and obligations outstanding in connection with the previously announced acquisition of Livestream Gaming, parent company of LOOT.BET. Under the terms of the share purchase agreement between React Gaming and the vendors of Livestream entered into in respect of the acquisition of Livestream, the Corporation agreed to issue a $4,000,000 secured vendor take back note in favour of the Vendors bearing 12% interest from the date of any default. Pursuant to the terms of the Debt Settlement agreement, the parties have agreed to settle the amounts outstanding under the Note and release each other from their respective obligations under the SPA in consideration that Corporation has agreed to pay the Vendors $200,000, upon the sale of any assets of the Corporation, or the closing of a future financing, and by no later than April 9, 2023. .
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| MESA | Hot Stocks07:30 EST Mesa Air to file Form 12b-25, delay release of Q4, 2022 results - Mesa Air Group announced that it will file a Form 12b-25, Notification of Late Filing, with the U.S. Securities and Exchange Commission with regard to its annual report on Form 10-K for the fiscal year ended September 30, 2022. Form 12b-25 will allow the Company an additional fifteen calendar days to file the 2022 10-K, which is due on December 14, 2022. In accordance with today's announcement, the Company is canceling its previously announced earnings release and call scheduled for after market close on December 12. The Company expects to file the 2022 10-K as soon as practicable and no later than the December 29, 2022 deadline in compliance with Rule 12b-25. As soon as the filing date is confirmed, the Company will announce the updated timing for the release of its 2022 fourth quarter and full year financial results and conference call.
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| KTTA | Hot Stocks07:29 EST Pasithea Therapeutics enters settlement agreement with the Camac Group - Pasithea Therapeutics announced that it has reached a comprehensive Settlement and Cooperation Agreement with Concord IP2 Ltd., Elderhill Corporation, Leonite Capital LLC, Leonite Fund I, LP, Camac Partners, LLC, Camac Capital, LLC, Camac Fund, LP, David Delaney, Avi Geller, and Eric Shahinian resolving all outstanding issues between the parties. Pursuant to the Agreement, the Camac Group has agreed to a three-year standstill provision and the parties have agreed to dismiss with prejudice the pending Delaware litigation against the Company and the Board filed by the Camac Group. Pasithea has agreed to purchase all 3,205,282 shares of the Company's common stock held by the Camac Group at a price of $1.0003 per share, the equivalent to the 5-day volume-weighted average price of the Company's common stock. Pasithea will also reimburse certain fees and expenses of the Camac Group. The Special Meeting of Stockholders occurred on December 9, 2022. The preliminary results indicate that the current members of the Company's Board of Directors will continue to serve and oversee the Company's business strategy.
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| MNPR | Hot Stocks07:27 EST Monopar Therapeutics announces MNPR-202 data from ongoing collaboration - Monopar Therapeutics released data with MNPR-202 from its ongoing collaboration with the Cancer Science Institute of Singapore at the National University of Singapore. The data are displayed in the poster that NUS and Monopar will be presenting this Sunday at the 64th American Society of Hematology Annual Meeting & Exposition. MNPR-202 is a DNA Damaging Response drug candidate, and analog of doxorubicin. It has the same potentially non-cardiotoxic backbone as camsirubicin, Monopar's clinical stage drug candidate that has shown a favorable heart toxicity profile to-date across three trials, but MNPR-202 is modified at additional sites with the intention of evading certain tumors' resistance mechanisms to doxorubicin. Prior exploratory preclinical studies in solid tumors have shown MNPR-202 to have a similar cytotoxic potency to doxorubicin while retaining that potency even in doxorubicin-resistant cancers. The present preclinical work by Dr. Anand Jeyasekharan corroborates MNPR-202's similar cytotoxic potency to doxorubicin even in blood cancers, while expanding the research in several exciting new directions, including a comparison to doxorubicin on DNA damage response, immune activation, apoptosis, gene expression, and synergy with other cancer compounds for combination usage. Data from blood cancer preclinical studies to date show that MNPR-202: has a similar cytotoxic potency to doxorubicin; generates increased DNA damage compared to doxorubicin; has a unique immune activation profile versus doxorubicin; demonstrates increased apoptosis compared to doxorubicin; causes a distinct set of genes to be upregulated and downregulated versus doxorubicin; and may be superior to doxorubicin in certain combination treatment regimens. A combination drug screen with 183 compounds was performed, revealing distinct differences in the synergy profile between doxorubicin and MNPR-202 with other compounds. As example, MNPR-202 demonstrated a more favorable synergy profile with volasertib compared to doxorubicin. The results generated to date suggest doxorubicin and MNPR-202 have a similar cytotoxic potency, but likely work through distinct cellular pathways and cause a different ancillary innate immune activation. These intracellular differences also influence drug synergies observed with the two compounds, implying that in the context of certain combinatorial regimens, MNPR-202 may be superior to doxorubicin. MNPR-202 also shows the potential to work in cancers resistant to doxorubicin. Taken together, we believe MNPR-202 has potential to disrupt the current chemotherapy landscape and impact a broad range of cancers.
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| GRTX | Hot Stocks07:24 EST Galera Therapeutics submits NDA for avasopasem for SOM - Galera Therapeutics announced the submission of its New Drug Application to the U.S. Food and Drug Administration for avasopasem for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. SOM is characterized by the inability to eat solid food or drink liquids and may require the surgical placement of feeding tubes to maintain nutrition and hydration. There are currently no FDA-approved drugs to reduce SOM for these patients. The NDA is supported by the randomized, double-blinded, placebo-controlled Phase 3 ROMAN and Phase 2b GT-201 trials which enrolled a total of 678 patients. Results from the 455-patient ROMAN trial demonstrated a clinically meaningful reduction in patients' SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Avasopasem also showed clinically meaningful reductions in severity of SOM compared to placebo. Exploratory analyses, such as time to SOM onset and SOM incidence at various landmarks of radiotherapy delivered, further demonstrated the clinical benefit of avasopasem in reducing the burden of SOM. Avasopasem was generally well tolerated compared to placebo. Overall, the adverse event incidences noted in the clinical trials were consistent with the interpretation that avasopasem was not associated with a clinically meaningful increase in the AE profile expected for the target patient population receiving standard-of-care chemoradiation therapy. In addition, a prospectively defined exploratory analysis looking at renal function through 12 months follow-up showed that avasopasem reduced cisplatin-induced chronic kidney disease by 50%.
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| LTBR | Hot Stocks07:23 EST Lightbridge enters long-term strategic partnership with Idaho National Lab - Lightbridge has entered into landmark agreements with Idaho National Laboratory, in collaboration with the U.S. Department of Energy, to support the development of Lightbridge Fuel. The framework agreements use an innovative structure and consist of an "umbrella" Strategic Partnership Project Agreement and an "umbrella" Cooperative Research and Development Agreement, each with Battelle Energy Alliance, DOE's operating contractor for INL, with an initial duration of seven years. It is anticipated that the initial phase of work under the two agreements will culminate in irradiation testing in the Advanced Test Reactor of fuel samples using enriched uranium supplied by DOE. The initial phase of work aims to generate irradiation performance data for Lightbridge's delta-phase uranium-zirconium alloy relating to various thermophysical properties. The data will support fuel performance modeling and regulatory licensing efforts for the commercial deployment of Lightbridge Fuel. It is anticipated that subsequent phases of work under the two umbrella agreements will include post-irradiation examination of the irradiated fuel samples, loop radiation testing in the ATR, and post-irradiation examination of one or more uranium-zirconium fuel rodlets, as well as transient experiments in the Transient Reactor Test Facility at INL.
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| ARDS | Hot Stocks07:21 EST Aridis receives $4.85M investment from the Cystic Fibrosis Foundation - Aridis Pharmaceuticals announced the Cystic Fibrosis Foundation invested $4.85M in Aridis common stock on market terms under NASDAQ rules to support the ongoing development of AR-501, an inhalable broad-spectrum anti-infective currently under development for controlling debilitating chronic lung infections in cystic fibrosis patients. Including this funding, the CF Foundation has provided a total of $12.5M in support. Enrollment for a Phase 2a study of AR-501 in CF patients was completed in November 2022. The company anticipates reporting top-line results from its Phase 2a study in the first quarter of 2023.
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| PYPD | Hot Stocks07:20 EST PolyPid schedules Type D meeting with FDA on SHIELD 1 Phase 3 results - PolyPid announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration to discuss the results of SHIELD I Phase 3 study and regulatory requirements to support the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study.
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| WEBR | Hot Stocks07:19 EST Weber to be taken private by BDT Capital in $8.05 per share transaction - Weber announced that it has entered into a definitive merger agreement pursuant to which investment funds managed by BDT Capital Partners will purchase all of the outstanding Class A Shares that they do not already own, for $8.05 per share of Class A common stock of Weber, which implies a total enterprise value of $3.7B for Weber. The purchase price represents a premium of 60% to the closing price of the Class A Shares on October 24, the last trading day before BDT submitted a non-binding acquisition proposal to the board of directors of the company and Weber disclosed the receipt of such proposal. A special committee of the board, comprised solely of independent directors, advised by its own independent financial and legal advisors, determined that the proposed transaction is in the best interests of the holders of Class A Shares other than BDT and unanimously recommended that the board approve the transaction. Acting upon the recommendation of the special committee, Weber's board approved the transaction. Upon completion of the transaction, Weber will become a privately held company majority owned by investment funds managed by BDT. The transaction is expected to close in the first half of 2023, subject to customary closing conditions, including HSR clearance. The transaction has been approved by the written consent of the holders of the requisite number of shares of common stock of Weber, such that no additional stockholder approval is required. In connection with the transaction, BDT managed investment funds will provide Weber with an additional unsecured loan facility in the aggregate principal amount of $350M. Weber intends to utilize the loan for general corporate purposes including repaying existing indebtedness, continuing to make necessary investments in capital expenditures that support new product initiatives, and funding working capital for the upcoming 2023 outdoor cooking season. The previous loan agreement that Weber entered into with BDT managed investment funds on November 8, 2022, will remain outstanding.
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| TNXP | Hot Stocks07:19 EST Tonix Pharmaceuticals obtains exclusive license from Curia Global - Tonix Pharmaceuticals Holding obtained an exclusive license from Curia Global for the development of three humanized murine monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19.
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| TCRX | Hot Stocks07:18 EST TScan presents progress from Phase 1 umbrella trial of TSC-100, TSC-101 - TScan Therapeutics announced a poster presentation on the clinical trial design and trial in progress for the Phase 1 umbrella trial of TSC-100 and TSC-101 to treat residual leukemia and prevent relapse after hematopoietic cell transplantation at the 64th American Society of Hematology Annual Meeting 2022. TScan has developed two lead TCR-T therapy candidates, TSC-100 and TSC-101, that express TCRs targeting minor histocompatibility antigens HA-1 and HA-2, respectively, both presented by HLA-A*02:01. The goal is to select HCT patients who are HA-1 or HA-2 positive and donors who are mismatched on either the MiHA or HLA-A*02:01, whereby TSC-100 and TSC-101 can eliminate all recipient hematopoietic cells while leaving donor cells unaffected. Both products are being developed in patients with acute myeloid leukemia, acute lymphocytic leukemia and myelodysplastic syndromes undergoing allogeneic haploidentical HCT with reduced intensity conditioning to eliminate any residual recipient hematopoietic cells after HCT and prevent disease relapse. Approximately 40% of patients with these diseases relapse within two years after RIC transplant, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable more patients to maintain prolonged remission after HCT using RIC, which is a more tolerable chemotherapy than myeloablative conditioning, followed by TScan's TCR-T.
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| MOD | Hot Stocks07:17 EST Modine Manufacturing teams with Air Solutions Partners - Modine Coatings, a division of Modine Manufacturing Company and a leader in corrosion-resistant coatings technology for the HVAC industry, is partnering with Air Solutions Partners to expand access to the GulfCoat Contractor Series product line and the Insitu Spray Applied Coating Services. Modine Coatings is partnering with Air Solutions Partners to expand access to the GulfCoat Contractor Series product line and the Insitu Spray Applied Coating Services. As part of the partnership, Air Solutions Partners, a RectorSeal manufacturing representative, will market Insitu Spray Applied Coating Services and the complete line of GulfCoat Contractor Series products in Texas and Oklahoma. The partnership will bring a dedicated focus to Modine Coating products and services for HVAC/R contractors to help maximize solutions in their respective markets.
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| MDLZ | Hot Stocks07:16 EST Mondelez, HCL Technologies announce expanded contract - HCL Technologies announced an expanded multi-year contract with Mondelez International, to enhance Mondelez International's cybersecurity and transform digital workplace services globally. To support its hybrid workplace model, Mondelez International deployed HCLTech's top rated BigFix platform to automate the discovery and remediation of potential vulnerabilities, ensuring all endpoints - including servers, mobile devices and laptops, are continuously secured and compliant.
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| KZIA | Hot Stocks07:16 EST Kazia Therapeutics announces receipt of Nasdaq minimum bid notification - Kazia Therapeutics received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market, dated December 9, 2022, notifying the company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Capital Market's rules for continued listing. The deficiency notification has no immediate impact on the company's operations or listing. Kazia's securities will continue to trade as normal on Nasdaq-CM under the ticker KZIA. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of at least US$ 1.00 per share, and failure to do so for a period of 30 consecutive business days triggers a deficiency notice. Based on the closing bid price of Kazia's American Depository Shares, each representing ten ordinary shares of the company, for the period from October 27, 2022 to December 8, 2022, the company no longer met this requirement as of December 8, 2022. The company will closely monitor the situation and intends to resolve the deficiency and regain compliance with the Nasdaq Listing Rules. The deficiency notice has no impact on the company's listing on the Australian Securities Exchange, where it continues to trade as normal under the ticker KZA.
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| CEVA | Hot Stocks07:15 EST Ceva promotes Toquet to role of Chief Commercial Officer - CEVA announced that Gweltaz Toquet has been promoted to the role of Chief Commercial Officer, CCO, of CEVA, reporting directly to incoming CEO, Amir Panush, effective January 1, 2023. Toquet will assume responsibility for CEVA's sales and customer success efforts worldwide, following Issachar Ohana's departure from his position as Executive Vice President of Worldwide Sales effective December 31, 2022. Gweltaz Toquet has been promoted to the role of Chief Commercial Officer CEVA. Toquet has more than 20 years of sales and management experience at CEVA, most recently serving as Vice President of Sales for APAC, India and Europe.
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| CLRC | Hot Stocks07:15 EST ClimateRock, E.E.W. Eco Energy World announces new investor presentation - E.E.W. Eco Energy World and ClimateRock announced that a new investor presentation is now available for viewing and accessible on both ClimateRock's website at https://www.climate-rock.com/ and EEW's website at https://www.eew.solar/investor.html. The presentation includes further details on the previously announced proposed business combination and EEW's market opportunities.
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| BCLI | Hot Stocks07:14 EST BrainStorm submits Type A Meeting Request to U.S. FDA - BrainStorm Cell Therapeutics announced that the company has submitted a Type A Meeting Request to the U.S. Food and Drug Administration, FDA, to discuss the contents of a refusal to file letter previously issued by the FDA regarding the company's New Biologics License Application, BLA, for NurOwn for the treatment of ALS. The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request. As previously reported, the contents of the refusal to file letter focus on topics related to chemistry, manufacturing, and controls, as well as clinical data and statistics. As part of the Type A Meeting, BrainStorm intends to discuss a path to an FDA Advisory Committee Meeting. "Participating in a Type A meeting will be an important next step towards enabling NurOwn's advancement through the regulatory process," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "The extensive briefing package submitted with our request contains a comprehensive strategy to fully address the CMC matters raised in the refusal to file letter. We anticipate achieving quick alignment with the FDA on the CMC strategy and expect that its execution will be straightforward. We therefore anticipate a Type A meeting focused primarily on discussing how we can secure an Advisory Committee Meeting, which we believe will be a critical step on NurOwn's path towards approval as an ALS therapy."
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| CLBT | Hot Stocks07:14 EST Cellebrite sings $10M deal with European national police force - Cellebrite DI announced that a European national police force extended its long-term partnership with Cellebrite, resulting in the future deployment of Cellebrite Pathfinder across multiple sites.
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| FFMGF | Hot Stocks07:13 EST First Mining Gold announces sale of non-core Goldlund NSR Royalty for C$9.5M - First Mining Gold announces that it has entered into a definitive royalty purchase agreement with an affiliate of Sprott Resource Streaming and Royalty to sell its 1.5% net smelter return, NSR, royalty on the Goldlund gold property in Ontario owned by Treasury Metals Inc. for total cash consideration of approximately C$9.5M, or $7M. "We are very excited to announce the sale of our Goldlund royalty to Sprott," stated Dan Wilton, CEO of First Mining. "Sprott is an existing royalty holder across the Goliath Gold Complex with a deep understanding of the project and this transaction is a further endorsement of the potential of the asset. First Mining continues to retain exposure to the success of the project as the largest shareholder of Treasury Metals while the proceeds from this royalty sale will provide the Company with additional financial flexibility as we continue to focus on advancing our two flagship assets, Springpole and Duparquet." Following the completion of the Goldlund Royalty Transaction, First Mining's royalty portfolio will be comprised of 20 royalties across four countries, which includes a 2.0% NSR royalty on the Pickle Crow gold project in Ontario operated by Auteco Minerals Ltd., a 1.5% NSR royalty on the Hope Brook gold project in Newfoundland operated by Big Ridge Gold Corp. and NSR royalties on a number of other exploration and development projects.
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| MTA GOLD | Hot Stocks07:12 EST Metalla Royalty & Streaming adds royalties on Barrick Gold's Lama project - Metalla Royalty & Streaming (MTA) announces it has entered into a Royalty Purchase Agreement, RPA, with an arm's length third-party dated December 9, 2022, to acquire an existing 2.5% to 3.75% gross value return royalty on gold and silver, and a 0.25% to 3.0% net smelter return royalty on copper and other non-precious minerals, extracted from the majority of the Lama project owned by Barrick Gold (GOLD) for total consideration of $7.5M in common shares and cash. Brett Heath, President & CEO of Metalla, commented, "The Lama project is part of one of the largest gold deposits in the world currently being contemplated by Barrick as a standalone operation. Our royalty will provide Metalla shareholders with outstanding exposure to one of the most significant geological gold bearing trends with a substantial amount of near-term growth, exploration upside, and first in class operator." Mr. Heath continued "We are excited by the $75 million being spent by Barrick on defining resources on the Lama extensions most of which is covered by the royalty area. This has resulted in some exciting drill results with a new discovery of a gold-copper porphyry style mineralization at depth. Barrick has initiated a study to evaluate the development of a standalone operation at Lama, on the Argentinean side, expected to be completed in Q2 2023, and provide a development decision for the Lama project in 2024."
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| SXC | Hot Stocks07:10 EST SunCoke Energy promotes Gates to President, appointed to board of directors - SunCoke Energy announced that Katherine Gates has been promoted to President and appointed to the Company's Board of Directors, effective January 1, 2023, consistent with the Board's executive leadership succession plan. As President, Ms. Gates will have general responsibility for management of the Company's operations. Gates will stand for election at the Company's 2023 Annual Meeting of Stockholders. Ms. Gates joined SunCoke in 2013, and has held various positions of increasing responsibility since then, most recently as the Company's Senior Vice President, Chief Legal Officer and Chief Human Resources Officer, since 2019.
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| CTM | Hot Stocks07:09 EST Castellum wins spot on Air Force Architecture and Integration Directorate IDIQ - Castellum announced that it is one of the winners of the Architecture and Integration Directorate Multiple Award Indefinite Delivery/Indefinite Quantity Contract contract. Castellum's award is through our subsidiary Specialty Systems. This multiple award IDIQ prime contract has a ceiling of $900,000,000 and a 10-year period of performance and is with the Department of the Air Force, Air Force Materiel Command, Air Force Life Cycle Management Center, Architecture, and Integration Directorate. As an awardee on this IDIQ contract, SSI can compete for task orders up to the $900,000,000 ceiling, for the development of innovative approaches that bring multi-domain systems capabilities, the characterization of new technologies and systems through studies, recurrent demonstration, and rapid development to enable rapid prototyping, and test and capability transition. The location of work performance will be determined at the contract delivery order level and is expected to be completed by December 2032. These awards are the result of full and open competition, and 94 responses were received. Fiscal 2022 operations and maintenance funds in the amount of $1,000 will be initially awarded to each contractor. Air Force Life Cycle Management, Wright Patterson AFB, Ohio, is the contracting activity.
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| GIA QTI | Hot Stocks07:09 EST QT Imaging to become public through GigCapital5 combination - GigCapital5 (GIA) and QT Imaging, announced that they have entered into a definitive business combination agreement that would result in QT Imaging becoming a publicly listed company subject to closing. Upon closing of the transaction, the combined company will be named QT Imaging Holdings, Inc. and will be traded on the NYSE under the new ticker symbol (QTI). The goal is to complete the business combination in the first half of 2023. The business combination values QT Imaging at an equity value of $151M. The combined company will receive approximately $41M in gross proceeds from GigCapital5's trust account, assuming no redemptions by GigCapital5's public stockholders, and up to $26M in additional financing to be raised prior to the closing of the business combination. The transaction has been approved unanimously by the boards of directors of both QT Imaging and GigCapital5 and is currently expected to close in the first half of 2023, subject to regulatory and stockholder approvals, and other customary closing conditions.
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| TSP GRND | Hot Stocks07:09 EST TuSimple appoints Lu to board of directors as an independent director - TuSimple (TSP) announced the appointment of James Lu to its Board of Directors as an Independent Director. Lu brings more than 20 years of experience in the technology sector as a seasoned entrepreneur, executive, and investor. Lu serves as the Chairperson of Grindr (GRND), the world's largest LGBTQ social dating application. In addition, Lu is Director, Chairman and Chief Executive Officer of Life Concepts Holdings Limited, an investment company mainly engaged in restaurant operations; Director of Fusion Media Limited, an Internet publishing company; and Director of Global Commerce Technology Limited, a software development company.
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| KPTI | Hot Stocks07:07 EST Karyopharm announces updated results from Phase 1 selinexor data - Karyopharm Therapeutics announced updated results from the Phase 1 portion of its study evaluating the safety and efficacy of once-weekly selinexor in combination with standard dose ruxolitinib in patients with treatment-naive myelofibrosis. The data, featured in a poster presentation at the 64th American Society of Hematology 2022 Annual Meeting and Exposition, show that the combination of selinexor with ruxolitinib achieved rapid and sustained spleen responses, encouraging improvements in symptoms and stabilization of hemoglobin levels in patients with treatment-naive myelofibrosis. As of October 21, 2022, 24 patients had been assigned to either a 40 mg or 60 mg once weekly dose of selinexor, in combination with ruxolitinib 15/20 mg BID. At week 24, 92% of efficacy evaluable patients demonstrated greater than or equal to35% reduction in spleen volume. Ongoing reductions in SVR were seen from baseline to week 12 and week 24, with a 45% median reduction at week 12 and a 49% median reduction at week 24. 67% of the evaluable patients for symptom response at week 24 achieved greater than or equal to50% reduction. 57% of transfusion-independent patients maintained or improved their hemoglobin levels. The safety population was comprised of 24 patients, all of whom received at least one dose of selinexor. The most common adverse events were nausea, anemia and fatigue, the majority of which were grades 1-2. The most common reported grade 3-4 treatment-emergent AEs were anemia and thrombocytopenia, both of which were reversible.
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| BMY | Hot Stocks07:07 EST Bristol-Myers announces first disclosures, new data at ASH 2022 - Bristol Myers Squibb announced the first disclosure of results and presentation of new research from its multiple myeloma portfolio across targets and molecular approaches at the 64th American Society of Hematology Annual Meeting and Exposition, underscoring the company's commitment to raising standards to transform multiple myeloma outcomes for every patient. Results being presented at ASH highlight scientific progress across bispecific T cell engagers, chimeric antigen receptor T cell therapies and novel CELMoDTM agents in advancing the treatment of relapsed/refractory multiple myeloma and include: First multicenter results from the Phase 1 study of bispecific TCE alnuctamab, administered subcutaneously every four weeks after six months, showing a reduction in inflammatory toxicity relative to intravenous administration, while maintaining anti-tumor activity with deep responses; First disclosure of Phase 1 results for GPRC5D CAR T, demonstrating deep and durable responses with a manageable safety profile across all dose levels, including patients previously treated with a B-cell maturation antigen-directed CAR T cell therapy; Two first disclosures of results from cohorts 2a and 2c of the Phase 2 KarMMa-2 trial evaluating Abecma, demonstrating durable responses and predictable safety in patients with multiple myeloma after early relapse or suboptimal response to stem cell transplant; First results from the dose expansion cohort of the mezigdomide Phase 1/2 study evaluating the novel oral CELMoD agent with dexamethasone, showing durable efficacy and a manageable safety profile in patients who were highly refractory to multiple prior therapies; New results from a cohort with patients previously exposed to a BCMA-targeted therapy of the iberdomide Phase 1/2 study, evaluating the novel oral CELMoD agent with DEX, demonstrating clinically meaningful efficacy and safety regardless of type of prior anti-BCMA treatment. Alnuctamab Phase 1 Study Results: Alnuctamab is a bispecific T cell engager that simultaneously binds myeloma cells expressing B-cell maturation antigen and T cells in a unique 2:1 fashion. This interaction aims to drive myeloma cell death by inducing T cell activation and release of proinflammatory cytokines and cytolytic enzymes. In the ongoing alnuctamab CC-93269-MM-001 open-label, Phase 1 study, 138 patients with relapsed/refractory multiple myeloma were enrolledto receive escalating doses of alnuctamab administered either intravenously or subcutaneously. Intravenous alnuctamab was administered as previously reported at target doses of 0.15-10 mg, with both fixed and step-up dosing, while SC alnuctamab was given to patients in two step-up doses followed by escalating target doses of 10, 15, 30, and 60 mg, given every one week for three months, then every two weeks for three months, followed by every four weeks after those six months. In interim results, SC alnuctamab showed an improved safety profile compared to IV delivery, with cytokine release syndrome limited to low-grade, short-lived events, allowing for dose escalation to higher target doses. Intravenous and SC alnuctamab both exhibited promising pharmacodynamic effects, triggering the release of the hallmark cytokines of TCEs. However, SC alnuctamab triggered reduced and delayed cytokine production compared to more potent CRS induced by IV delivery. Subcutaneous alnuctamab also demonstrated encouraging dose-dependent anti-tumor activity across all target doses, particularly in patients who received the 30 mg target dose. GPRC5D CAR T Phase 1 Study Results: GPRC5D has been identified as an orphan receptor that is highly expressed on multiple myeloma cells, with limited expression in other tissues. BMS-986393 is a GPRC5D-directed autologous CAR T cell therapy. This Phase 1, first-in-human, multicenter, open-label study is evaluating BMS-986393 in patients with R/R multiple myeloma who had received three or more prior lines of therapy. Prior BCMA-targeted treatment, including CAR T cell therapy, was allowed. Primary objectives of the study were to determine safety and tolerability of BMS-986393 and inform the recommended dose for future development. At the time of the interim analysis, BMS-986393 demonstrated a well-tolerated safety profile with mostly low-grade and short-lived occurrences of CRS and neurotoxicity across all tested dose levels. Neurotoxicity was infrequent and low-grade, with no Grade 3 or 4 events reported, and events were reversible with steroid treatment. All on-target off-tumor adverse events were Grade 1, and the majority did not require treatment. Preliminary efficacy also supports the potential of BMS-986393 to elicit deep and durable responses. Abecma KarMMa Phase 2 Cohorts 2a and 2c Study Results: KarMMa-2 is a multi-cohort, open-label, multicenter Phase 2 trial evaluating Abecma in patients with relapsed and refractory multiple myeloma, patients with multiple myeloma who have progressive disease within 18 months of initial treatment including autologous stem cell transplant, or in patients with inadequate response following ASCT during initial treatment. Based on results from Cohorts 2a and 2c, Abecma demonstrated complete and durable responses in a significant proportion of patients, alongside a well-established and predictable safety profile with mostly low-grade occurrences of CRS and neurotoxicity. Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Novel CELMoD agents mezigdomide and iberdomide Phase 1/2 Study Results: Cereblon E3 ligase modulators are a class of oral immunomodulatory therapeutics that are designed to stimulate the immune system and directly kill cancer cells by inducing the degradation of tumor-promoting proteins. Bristol Myers Squibb is investigating two novel CELMoD agents, mezigdomide and iberdomide, for multiple myeloma that were intentionally designed to improve upon the demonstrated efficacy of the IMiD agents, along with manageable tolerability, ease of administration, and the potential to improve patient outcomes. These agents co-opt cereblon to induce degradation of target proteins Ikaros and Aiolos, which inhibits tumor cell proliferation, promote tumor cell death, and induce immune-stimulatory effects The mezigdomide CC-92480-MM-001 trial is an ongoing open-label, international Phase 1/2 study to investigate the safety and efficacy of mezigdomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. As part of the expansion cohort phase, 101 highly refractory patients that had received three or more prior lines of therapy, including an IMiD agent, a proteasome inhibitor, and an anti-CD38 mAb, were given mezigdomide for 21 of 28 days in combination with weekly DEX at the recommended Phase 2 dose selected in part 1 of the study. The primary objective was efficacy as determined by objective response rate, while safety, tolerability and additional efficacy measures were included as the secondary objectives. Based on interim results, mezigdomide, in combination with weekly DEX, showed promising efficacy in a highly refractory patient population. As of the data cut-off date, mezigdomide plus DEX showed a manageable safety profile.
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| VRTS | Hot Stocks07:06 EST Virtus Investment reports preliminary AUM of $157.2B as of November 30 - In addition, the company provided services to $2.6 billion of other fee-earning assets, which are not included in assets under management, AUM.
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| ADN | Hot Stocks07:05 EST Advent Technologies announces delivery of Serene HT-PEM fuel cell systems - Advent Technologies announced the successful delivery of its Serene HT-PEM fuel cell systems to BSZ Netz, or BSZ, a German-based subsidiary of TSG Transmission Systems Germany GmbH, specializing in the manufacturing and distribution of sustainable redundant power supply solutions across the European market.
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| SAM | Hot Stocks07:05 EST Boston Beer's TeaPot launches merchandise collaboration with Peace Collective - The Boston Beer Company unveiled the 'Stop the Stigma' merchandise collaboration between TeaPot, Boston Beer's new line of cannabis-infused iced teas, and Peace Collective, a Canadian lifestyle apparel brand. Net proceeds from the merchandise go directly to Pardons Canada, a national non-profit that assists individuals with criminal convictions to obtain pardons, record suspensions, U.S. entry waivers and file destructions.
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| HEES | Hot Stocks07:04 EST H&E Equipment to sell Komatsu earthmoving distribution business - H&E Equipment announced the signing of a definitive agreement to sell its Komatsu earthmoving distribution business to Houston, Texas based Waukesha-Pearce Industries. The transaction includes rights to the distribution of earthmoving equipment in the state of Louisiana and counties located in southwestern Arkansas, along with a distribution facility in Kenner, Louisiana, and certain other equipment, parts and supplies. Also, H&E will assign to WPI the outstanding lease on its distribution facility in Bossier City, Louisiana. H&E will retain ownership of its rental assets located at the remaining seven rental branches in Louisiana. The transaction is expected to close by December 31, subject to customary closing conditions.
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| COUP | Hot Stocks07:03 EST Coupa Software to be acquired by Thoma Bravo for $81 per share in cash - Coupa Software announced that it has entered into a definitive agreement to be acquired by Thoma Bravo, a leading software investment firm. This is an all-cash transaction with an enterprise value of $8B. Upon completion of the transaction, Coupa will become a privately held company. The transaction includes a significant minority investment from a wholly owned subsidiary of the Abu Dhabi Investment Authority. Under the terms of the agreement, Coupa shareholders will receive $81.00 per share in cash, which represents a 77% premium to Coupa's closing stock price on November 22, 2022, the last full trading day prior to media reports regarding a possible sale transaction involving the company. The transaction consideration also represents a premium of approximately 64% to the volume weighted average closing price of Coupa stock for the 30 trading days ending on November 22, 2022. "For more than a decade, we've been building an incredible Business Spend Management Community and have proudly cemented our position as the market-leading platform in our category. We're looking forward to partnering with Thoma Bravo and accelerating our vision to digitally transform the Office of the CFO," said Rob Bernshteyn, chairman and chief executive officer at Coupa. "While our ownership may change, our values do not. Every one of us at Coupa will continue to put our customers at the center of everything we do and help them maximize the value of every dollar they spend." Approvals and Timing: The transaction, which was approved unanimously by the Coupa Board of Directors, is expected to close in the first half of 2023, subject to customary closing conditions, including approval by Coupa shareholders and the receipt of required regulatory approvals. The transaction is not subject to a financing condition. Upon completion of the transaction, Coupa's common stock will no longer be listed on any public market. The company will continue to operate under the Coupa name and brand.
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| UNH... | Hot Stocks07:00 EST UnitedHealth appoints Kristen Gil to board of directors - UnitedHealth Group (UNH) announced Kristen Gil of Alphabet Inc. (GOOG, GOOGL) has been appointed to its Board of Directors, effective immediately. Gil currently serves as vice president, business finance officer, at Google.
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| LAZ | Hot Stocks06:59 EST Lazard appoints reports $221B in AUM as of November 30 - Lazard reported that its preliminary assets under management as of November 30, 2022 totaled approximately $221B. The month's AUM included market appreciation of $12.1B, foreign exchange appreciation of $4.3B and net inflows of $0.1B.
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| KLR | Hot Stocks06:57 EST Kaleyra announces CEO transition plan, board enhancements - Kaleyra announced a CEO transition plan and significant enhancements to its Board of Directors to reposition the company for sustainable growth and value creation. Kaleyra has announced that Mr. Dario Calogero, its founder and CEO, has notified the Board of his intention to step down from his position as CEO of the company after serving over 20 years in the role. The Board has retained a leading independent executive search firm to assist with the CEO search process. Calogero will continue his service to the company as a director and will remain in his role as the company's CEO to support the leadership transition and ensure continuity and stability until the Board selects a new CEO. Upon the appointment of Calogero's successor, Calogero will transition to the newly created role of Chief Strategy Officer, in which he will focus on organic and inorganic growth strategies for the company. Kaleyra also announced today that it has appointed Kathleen Miller and Karin-Joyce Tjon as directors to the company's Board of Directors, effective immediately. Upon the appointments of Miller and Tjon, the Board will consist of eight directors, all of whom, other than Calogero, will be independent.
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| EGRX | Hot Stocks06:56 EST Eagle Pharmaceuticals reaches settlement agreement with Accord - Eagle Pharmaceuticals announced that it has reached a settlement agreement with Accord Healthcare. Eagle had asserted its Orange Book-listed patents against Accord related to Accord's new drug application referencing BENDEKA. The settlement agreement provides that Accord has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The settlement with Accord follows Eagle's previously announced settlement with Hospira, Inc. regarding two Orange Book-listed patents, which granted Hospira the right to market its product beginning January 17, 2028, or earlier based on certain circumstances.
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| TRI... | Hot Stocks06:55 EST Thomson Reuters, Blackstone to sell shares of LSEG to Microsoft - Thomson Reuters (TRI) announced that it and certain investment funds affiliated with Blackstone (BX) have agreed to sell shares in London Stock Exchange Group plc that they co-own to Microsoft (MSFT). Thomson Reuters plans to use the approximately $1B of gross proceeds from the transaction to pursue organic and inorganic opportunities in key growth segments and provide returns to shareholders. Closing of the transaction is subject to customary antitrust and regulatory approvals and is expected to complete in the first quarter of 2023. In connection with the transaction, LSEG has agreed to amend the terms of contractual lock-up provisions previously agreed between LSEG and the Blackstone/Thomson Reuters entities that hold the LSEG shares. As a result of the amendment, the number of LSEG shares that the Blackstone/Thomson Reuters entities will be able to sell, in aggregate, between January 30, 2023 and January 29, 2024 will be unchanged and the number of LSEG shares that the Blackstone/Thomson Reuters entities will be able to sell between January 30, 2024 and January 29, 2025 will be reduced by half of the number of shares sold to Microsoft. The contractual lock-up provisions cease to apply after January 29, 2025.
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| DNN | Hot Stocks06:54 EST Denison Mines completes neutralization phase of Phoenix ISR field test - Denison Mines announced the successful completion of the neutralization phase of the Phoenix in-situ recovery Feasibility Field Test at the Company's 95% owned Wheeler River project. Sampling of monitoring wells around the FFT site has confirmed the successful restoration of the Leaching Zone to environmentally acceptable pH conditions, as outlined in the applicable regulatory approvals for the FFT.
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| UNH... | Hot Stocks06:52 EST UnitedHealth appoints Alphabet business finance officer Kristen Gil to board - UnitedHealth (UNH) announced Kristen Gil of Alphabet (GOOG) has been appointed to its board of directors, effective immediately. Gil currently serves as vice president, business finance officer, at Google. She has held numerous senior positions at parent company Alphabet since joining the company in 2007, including in business operations, strategy, and finance for Google Search, Maps, Research & AI, and Sustainability.
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| MRK | Hot Stocks06:49 EST Merck begins tender offer to acquire Imago BioSciences for $36 per share - Merck (MRK) is commencing through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Imago BioSciences, Inc. (IMGO). On Nov. 21, 2022, Merck announced that it had entered into a definitive agreement to acquire Imago. Upon the successful closing of the tender offer, stockholders of Imago will receive $36 in cash for each share of Imago common stock validly tendered and not validly withdrawn in the offer, without interest and subject to deduction for any required tax withholding. Following the purchase of shares in the tender offer, Imago will merge with and into a subsidiary of Merck, with Imago surviving the merger. As a result, Imago will become a subsidiary of Merck. Merck will file today with the U.S. Securities and Exchange Commission a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Imago will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Imago board of directors that their stockholders accept the tender offer and tender their shares. The tender offer will expire at one minute after 11:59 p.m., Eastern Time, on January 10, 2023, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Imago's outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the first quarter of 2023.
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| LAZ | Hot Stocks06:48 EST Lazard reports preliminary November AUM $221B - Lazard reported that its preliminary assets under management, or AUM, as of November 30 totaled approximately $221B. The month's AUM included market appreciation of $12.1B, foreign exchange appreciation of $4.3B and net inflows of $0.1B.
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| MRK IMGO | Hot Stocks06:47 EST Merck commences offer to acquire Imago BioSciences for $36.00 per share - Merck (MRK), is commencing, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Imago BioSciences (IMGO). On November 21, Merck announced that it had entered into a definitive agreement to acquire Imago. Upon the successful closing of the tender offer, stockholders of Imago will receive $36 in cash for each share of Imago common stock validly tendered and not validly withdrawn in the offer, without interest and subject to deduction for any required tax withholding. Following the purchase of shares in the tender offer, Imago will merge with and into a subsidiary of Merck, with Imago surviving the merger. As a result, Imago will become a subsidiary of Merck. Merck will file today with the U.S. Securities and Exchange Commission a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Imago will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Imago board of directors that their stockholders accept the tender offer and tender their shares. The tender offer will expire at one minute after 11:59 p.m., Eastern Time, on January 10, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Imago's outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the first quarter of 2023.
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| SCTL | Hot Stocks06:46 EST Societal CDMO announces proposed concurrent public offerings - Societal CDMO announced that it is offering to sell, subject to market and other conditions, shares of its common stock and shares of its Series A convertible preferred stock in two concurrent but separate underwritten public offerings. The offerings are being made by means of separate preliminary prospectus supplements and are not contingent upon each other. The offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offerings may be completed or as to the actual size or terms of the offerings. RBC Capital Markets is acting as sole book-running manager for the offerings. Societal intends to use the net proceeds from the proposed offerings for the repayment of its outstanding debt facility with Athyrium and associated costs to satisfy closing conditions for a capital structure refinancing, including a sale-leaseback transaction in connection with its facility in Gainesville, Georgia and a new 3-year Term A Loan debt facility with Royal Bank of Canada. Societal intends to use the net proceeds from the proposed offerings, together with proceeds from the new Term A Loan and the sale-leaseback transaction, to repay in full and retire the outstanding debt facility with Athyrium, with any remaining proceeds to be used for general corporate and working capital purposes.
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| SCTL | Hot Stocks06:46 EST Societal CDMO signs deal for sales, leaseback transaction with Tenet Equity - Societal CDMO announced key progress in its multi-step strategy designed to recast the company's capital structure and strengthen its balance sheet. The company is working toward the concurrent closing of separate transactions, which are intended to reduce and refinance its outstanding senior debt. First, Societal CDMO announced that it has signed an agreement for a sale and leaseback transaction of its Gainesville, Georgia, manufacturing site and campus with Tenet Equity, a net lease platform. Upon closing, the transaction will yield $39 million in non-dilutive gross proceeds, which the company intends to use to immediately reduce its outstanding debt balance with Athyrium Capital Management. At closing, Societal CDMO will enter into a 20-year lease agreement with Tenet Equity, with multiple renewal options. In connection with the transaction, Tenet has also provided a forward funding commitment of up to an additional $35 million for future renovations or expansions, subject to customary approvals. This transaction does not impact Societal CDMO's other facilities, including its development, high potency and clinical packaging site also located in Gainesville, Georgia, and its development and sterile vial fill/finish & lyophilization facility in San Diego, California. This sale and leaseback agreement follows Societal CDMO's recently announced sale and purchase agreement to sell approximately 121 acres of unused lakefront land adjacent to its primary Gainesville manufacturing facility, which is expected to generate an additional $9 million in non-dilutive capital upon closing. Second, the company today announced that it has signed an agreement with Royal Bank of Canada for a new Term A Loan debt facility for up to $37.5 million to be funded subject to certain terms and conditions therein, including the obligation for the Company to raise no less than $32.5 million in proceeds from a qualified equity financing. The facility is in the form of a three-year Term A Loan bearing interest at the floating Secured Overnight Financing Rate plus an initial base rate of 4.5% per annum. Upon closing, proceeds from the Term A Loan will be immediately used to further reduce Societal CDMO's outstanding debt balance with Athyrium, which carries a combined interest rate of approximately 13% and holds a near-term maturity date of December 31, 2023. All amounts outstanding under the Athyrium debt facility will be repaid in full upon the funding of the Royal Bank of Canada facility. The closing of the sale and leaseback transaction is conditioned on, among other things, a paydown in the outstanding principal amount of our outstanding debt. The funding of the new debt facility with Royal Bank of Canada is contingent upon the completion of the sale and leaseback transaction, the completion of at least a $32.5 million equity financing and the full repayment of the company's existing debt facilities.
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| ZDGE | Hot Stocks06:39 EST Zedge enables monetization of GuruShots player's photos - Zedge announced the availability for GuruShots players to sell their photos in Zedge's marketplace. Zedge's marketing on GuruShots focuses on converting GuruShots players into Zedge Premium marketplace sellers. Some of these initial tools include an easy prompt to explore selling, pre-approval to sell in Zedge's marketplace, making it easy to upload content, including the ability to offer photos as NFTs. Future updates will include the ability for GuruShots players to have relevant photos which they uploaded to GuruShots automatically appear for sale in their Zedge Premium accounts, making the process even more seamless.
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| BVH | Hot Stocks06:38 EST Bluegreen Vacations increases common stock offer price to $25.00 per share - Bluegreen Vacations announced that it has amended its previously announced tender offer to purchase up to 4.5M shares of its Class A Common Stock to increase the offer price from $22.17 per share in cash to $25.00 per share in cash, in each case, less applicable holding taxes and without interest. The new offer price of $25.00 per share represents a 46.6% premium over the closing share price of the company's Class A Common Stock of $17.05 on November 2, the last trading day prior to the company's announcement of its intention to commence the tender offer. In connection with the amendment, the company has extended the expiration time of the tender offer from 5:00 p.m., Eastern time, on Friday, December 9 until 5:00 p.m., Eastern time, on Friday, December 23. Based on information provided by American Stock Transfer & Trust Company, the depositary for the tender offer, as of 5:00 p.m., Eastern time, on December 9, which was the previous expiration time of the tender offer, 1,895,853 shares had been tendered for purchase in the tender offer. Shareholders who have validly tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in connection with the amendment and extension of the tender offer, and they will receive the increased purchase price for their shares if the tender offer is completed and those shares are not withdrawn prior to the new expiration time.
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| TRX | Hot Stocks06:38 EST TRX Gold announces assay results from program at Buckreef Gold Main Zone - TRX Gold announces assay results from its 19-hole metallurgical variability sampling program on the Buckreef Gold Main Zone. The results are positive and significant for the Company as they continue to demonstrate: continuity of mineralization down dip and along strike of the deposit; and excellent width and grade of mineralization. As part of the upcoming metallurgical variability study, using core from this program, the Company will assess the amenability of the sulphide material to be processed through the existing processing plant, using its relatively simple flowsheet. In turn, this may have positive implications for potential plant expansions. Highlights include: Hole BMMT015 intersected 28.0 m grading @ 10.68 g/t Au from 0 m; Hole BMMT020 intersected 123.0 m grading @ 2.69 g/t Au from 3 m; Hole BMMT009 intersected 121.0 m grading @ 2.96 g/t Au from 3 m; Hole BMMT022 intersected 106.0 m grading @ 4.19 g/t Au from 85 m, 77 m grading @ 3.09 g/t from 241 m; and Hole BMMT021 intersected 90.0 m grading @ 1.56 g/t Au from 139 m.
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| HYRE | Hot Stocks06:36 EST HyreCar appoints Eduardo Iniguez as interim CEO - On Friday, December 9, 2022, HyreCar announced the appointment of Eduardo Iniguez as Interim CEO of HyreCar. Iniguez is laser-focused on managing the joint venture as it continues to acquire and deploy cars through the line. At the same time, he will continue to optimize operating expenses to accelerate the company's path towards cash flow breakeven. Prior to HyreCar, Iniguez was the VP of Corporate Finance at AllClear. In the past seven months at HyreCar, he has led the restructuring of headcount to build lean, high-performing teams and aggressively managed spend to balance growth and margin expansion.
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| HYRE | Hot Stocks06:34 EST HyreCar provides update on joint venture with AmeriDrive - HyreCar announced updates on progress of its joint venture with AmeriDrive and changes to its leadership team. On September 6, 2022, HyreCar closed a $100 million revolving line of credit with Credit Suisse and Medalist Partners for its fleet partner, AmeriDrive, to purchase cars for exclusive listing on HyreCar through a joint venture. Since October 19, 2022, the joint venture company has drawn $25 million on the line for the purchase of over 1,300 vehicles, with 1,000 vehicles already acquired. Over 200 net new cars have been in-fleeted with utilization approaching 70%. The balance of the vehicles, approximately 800, are expected to be in-fleeted within 60 days as they complete reconditioning and are moved to new markets.
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| TTNP OCUL | Hot Stocks06:33 EST Titan Pharmaceuticals enters licensing agreement with Ocular Therapeutix - Titan Pharmaceuticals (TTNP) announced that it has granted an exclusive license to Ocular Therapeutix Inc. (OCUL) pertaining to certain patent applications for ophthalmic uses in both humans and nonhuman animals in the territory of the United States. Under the terms of the agreement, Ocular will pay Titan an upfront licensing fee with the potential for additional payments upon reaching certain milestones.
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| BVH | Hot Stocks06:31 EST Bluegreen Vacations amends tender offer to increase price to $25 per share - Bluegreen Vacations Holding Corporation announced that it has amended its previously announced tender offer to purchase up to 4,500,000 shares of its Class A Common Stock to increase the offer price from $22.17 per share in cash to $25.00 per share in cash, in each case, less applicable holding taxes and without interest. The new offer price of $25.00 per share represents a 46.6% premium over the closing share price of the Company's Class A Common Stock of $17.05 on November 2, 2022, the last trading day prior to the Company's announcement of its intention to commence the tender offer. In connection with the amendment, the Company has extended the expiration time of the tender offer from 5:00 p.m., Eastern time, on Friday, December 9, 2022 until 5:00 p.m., Eastern time, on Friday, December 23, 2022. Based on information provided by American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, as of 5:00 p.m., Eastern time, on December 9, 2022, which was the previous expiration time of the tender offer, 1,895,853 shares had been tendered for purchase in the tender offer. Shareholders who have validly tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in connection with the amendment and extension of the tender offer, and they will receive the increased purchase price for their shares if the tender offer is completed and those shares are not withdrawn prior to the new expiration time.
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| APTO | Hot Stocks06:16 EST Aptose Biosciences establishes at-the-market facility - Aptose Biosciences announced it has entered into an equity distribution agreement with JonesTrading Institutional Services LLC, as agent. Under the terms of the Equity Distribution Agreement, the Company may, from time to time, issue and sell through the Agent, common shares of the Company through "at-the-market" distributions on the Nasdaq Capital Market. Aptose will determine, at its sole discretion, the time, price and number of Common Shares to be sold under the Offering. In connection with the Offering, Aptose filed a prospectus supplement with the U.S. Securities and Exchange Commission, qualifying the offer and sale of Common Shares having an aggregate offering price of up to $50M.
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| AOTVF | Hot Stocks06:13 EST Ascot Resources arranges C$200M financing package for Premier Gold Project - Ascot Resources has entered into non-binding letters of intent for a total of approximately C$200 million in project financing for construction of the Premier Gold Project, located on Nisga'a Nation Treaty Lands in the prolific Golden Triangle of northwestern British Columbia. The proposed finance package will consist of a US$110 million gold and silver streaming agreement with Sprott Resource Streaming and Royalty Corp. and/or its affiliates and a strategic equity investment by Ccori Apuof C$45 million, a portion of which will be structured as Canadian Development Expenditures flow through shares, such that the total gross proceeds to the Company is C$50 million. Ccori Apu's shareholders are the majority shareholders of Compania Minera Poderosa, which owns and operates a high-grade gold mine in northern Peru and produces approximately 300,000 ounces of gold per year. Ascot is also pleased to provide an update on the construction plans for PGP and the path towards production, which is anticipated in early 2024. Proposed finance package highlights Ascot will be funded with approximately C$200 million in project finance for construction of PGP, to repay the outstanding principal and accrued interest of the senior credit facility and production payment agreement from Sprott Private Resource Lending II in order to enter into production with minimal debt. Ascot maintains its previously announced targeted project timeline, with plant pre-commissioning to start in Q4 2023 and first gold pour anticipated to occur in early 2024. Gold and silver stream with Sprott Streaming: US$110 million for delivery of 8.75% and 100% of gold and silver production, respectively, from PGP and RMP for ongoing payment of 10% of prevailing gold and silver prices. Existing 10% gold streaming agreement with SRSR on the Red Mountain Project to be altered. Strategic Investment by Ccori Apu of C$45 million, a portion of which will be structured as CDE flow through, such that the total gross proceeds to Ascot is C$50 million, resulting in Ccori Apu having a 19.9% pro forma ownership of Ascot common shares upon closing and the right to nominate up to two people to Ascot's Board of Directors. The US$10 million convertible facility from Beedie Investments remains outstanding and Beedie will enter into an intercreditor agreement with SRSR. The Company has sent a cancellation notice to Beedie to cancel the undrawn convertible facility of US$15 million effective on December 12, 2022. The completion of the Stream and the Strategic Investment are each conditional on the other being completed.
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| HZNP AMGN | Hot Stocks06:11 EST Amgen to acquire Horizon Therapeutics for $116.50 per share in cash - The board of directors of Horizon Therapeutics (HZNP) and the board of directors of Amgen (AMGN) announced that they have reached agreement on the terms of a cash offer for the company by Pillartree, a newly formed private limited company wholly owned by Amgen, which is unanimously recommended by the company board and pursuant to which acquirer sub will acquire the entire issued and to be issued ordinary share capital of the company. Under the terms of the acquisition, each company shareholder at the Scheme Record Time will be entitled to receive: $116.50 for each Company Share in cash. The acquisition represents: a premium of approximately 47.9% to the closing price of $78.76 per company share on November 29 and a premium of approximately 19.7% to the closing price of $97.29 per company share on December 9. The acquisition values the entire issued and to be issued ordinary share capital of the company at approximately $27.8B on a fully diluted basis and implies an enterprise value of approximately $28.3B. Amgen has entered into a Bridge Credit Agreement, dated December 12, for an aggregate amount of $28.5B. Having taken into account the relevant factors and applicable risks, the company board, which has been so advised by Morgan Stanley, which as financial advisor to the company board has rendered a fairness opinion, considers the terms of the acquisition as set out in this announcement to be fair and reasonable. In providing its advice to the company board, Morgan Stanley has taken into account the commercial assessments of the company directors. The company board has unanimously determined that the transaction agreement and the transactions, including the scheme, are advisable for, fair to and in the best interests of, the company shareholders. Accordingly, the company board unanimously recommends that company shareholders vote in favor of the scheme meeting resolution and the Required EGM Resolutions, or, if the acquisition is implemented by a takeover offer, accept or procure acceptance of such takeover offer. It is agreed that the acquisition will be implemented by way of an Irish High Court-sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act. The acquisition will be subject to the satisfaction or waiver of the conditions, which are set out in full in Appendix 3 to this announcement, including, in summary: the requisite approval by company shareholders of the scheme meeting resolution and the required EGM Resolutions; the sanction of the scheme by the Irish High Court and the receipt of required antitrust clearances in the United States, Austria and Germany and the receipt of required foreign investment clearances in France, Germany, Denmark and Italy. It is expected that the scheme document, containing further information about the acquisition and notices of the scheme meeting and the EGM, the expected timetable for completion and action to be taken by company shareholders, will be published as soon as practicable. It is anticipated that the scheme will, subject to obtaining the necessary regulatory approvals, be declared effective in the first half of 2023. An expected timetable of key events relating to the acquisition will be provided in the scheme document.
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| MPWR | Hot Stocks06:10 EST Monolithic Power signs semiconductor supply agreement with VIS - Monolithic Power Systems and Vanguard International Semiconductor Corporation entered into a foundry agreement to produce power semiconductors. MPS will utilize VIS's 8-inch wafer fabrication capabilities in its Singapore and Taiwan manufacturing facilities. To secure semiconductor supplies for the long term, MPS is deepening partnerships with suppliers at key points in the supply chain. The products manufactured at VIS will meet the growing demand for power devices in datacenters, electric vehicles, solar inverters, robotics, and space systems.
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| FNHC | Hot Stocks06:09 EST FedNat Holding voluntarily files for Chapter 11 bankruptcy protection - FedNat Holding Company announced that it and certain of its wholly-owned subsidiaries have filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Florida in order to maximize value for all stakeholders. As part of the Chapter 11 process, the Company will evaluate all strategic alternatives to maximize value for stakeholders, whether that be a reorganization of its business or a sale of its assets. The Company has approximately $6.5 million of cash on hand, which will provide liquidity to support day-to-day operations during the Chapter 11 process, enabling the Company to operate business uninterrupted, including the timely payment of employee wages and benefits and continued servicing of customers. As part of the reorganization process, the Company will file customary "First Day" motions to allow it to maintain operations in the ordinary course. The Company intends to pay its employees in the usual manner and continue their primary benefits and certain customer programs without disruption. The Company expects to receive court approval for all these routine requests. To manage the restructuring process, the Company has engaged GGG Partners as financial advisors, and Nelson Mullins Riley & Scarborough LLP as legal advisors.
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| IR | Hot Stocks06:07 EST Ingersoll-Rand named to 2022 Dow Jones Sustainability Indices - Ingersoll Rand has been named to both the Dow Jones Sustainability World Index and the Dow Jones Sustainability North America Index.
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| AMGN HZNP | Hot Stocks06:06 EST Amgen to acquire Horizon Therapeutics for $116.50 per share in cash - The board of directors of Horizon Therapeutics (HZNP) and the board of directors of Amgen (AMGN) are pleased to announce that they have reached agreement on the terms of a cash offer for the Company by Pillartree Limited, a newly formed private limited company wholly owned by Amgen, which is unanimously recommended by the Company Board and pursuant to which Acquirer Sub will acquire the entire issued and to be issued ordinary share capital of the Company. Under the terms of the Acquisition, each Company Shareholder at the Scheme Record Time will be entitled to receive: $116.50 for each Company Share in cash. The Acquisition represents: a premium of approximately 47.9% to the closing price of $78.76 per Company Share on November 29, 2022; and a premium of approximately 19.7% to the closing price of $97.29 per Company Share on December 9, 2022. The Acquisition values the entire issued and to be issued ordinary share capital of the Company at approximately $27.8 billion on a fully diluted basis and implies an enterprise value of approximately $28.3 billion. Amgen has entered into a Bridge Credit Agreement, dated December 12, 2022, for an aggregate amount of $28.5 billion, by and among Amgen, Citibank N.A., as administrative agent, Bank of America, N.A., as syndication agent, and Citibank, N.A. and Bank of America, N.A. as lead arrangers and book runners, and the other banks from time to time party thereto to finance, together with Amgen's own cash resources, the Acquisition. Further information on the financing of the Acquisition will be set out in the Proxy Statement. Amgen believes that there is a compelling strategic and financial rationale for undertaking the Acquisition, which is expected to deliver the following benefits: Generates robust cash flow to support capital allocation priorities, including ongoing investment in innovation and continued dividend growth while sustaining a commitment to an investment grade credit rating; Accelerates revenue growth and is expected to be accretive to non-GAAP earnings per share from 2024; and Increases efficiency for the Combined Group, leading to an estimated annual pre-tax cost reduction of at least $500 million by the end of the third fiscal year following Completion. Having taken into account the relevant factors and applicable risks, the Company Board, which has been so advised by Morgan Stanley, which as financial advisor to the Company Board has rendered a fairness opinion, considers the terms of the Acquisition as set out in this Announcement to be fair and reasonable. In providing its advice to the Company Board, Morgan Stanley has taken into account the commercial assessments of the Company Directors. The Company Board has unanimously determined that the Transaction Agreement and the Transactions, including the Scheme, are advisable for, fair to and in the best interests of, the Company Shareholders. Accordingly, the Company Board unanimously recommends that Company Shareholders vote in favour of the Scheme Meeting Resolution and the Required EGM Resolutions, or, if the Acquisition is implemented by a Takeover Offer, accept or procure acceptance of such Takeover Offer. It is agreed that the Acquisition will be implemented by way of an Irish High Court-sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act. The Acquisition will be subject to the satisfaction or waiver of the Conditions, which are set out in full in Appendix 3 to this Announcement, including, in summary: the requisite approval by Company Shareholders of the Scheme Meeting Resolution and the Required EGM Resolutions; the sanction of the Scheme by the Irish High Court; and the receipt of required antitrust clearances in the United States, Austria and Germany and the receipt of required foreign investment clearances in France, Germany, Denmark and Italy. It is expected that the Scheme Document, containing further information about the Acquisition and notices of the Scheme Meeting and the EGM, the expected timetable for Completion and action to be taken by Company Shareholders, will be published as soon as practicable. It is anticipated that the Scheme will, subject to obtaining the necessary regulatory approvals, be declared effective in the first half of 2023. An expected timetable of key events relating to the Acquisition will be provided in the Scheme Document.
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| AMGN HZNP | Hot Stocks06:02 EST Amgen to acquire Horizon Therapeutics for $116.50 per share in cash
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| MSFT | Hot Stocks05:36 EST Microsoft to buy 4% stake in LSEG amid 10-year cloud partnership - London Stock Exchange Group and Microsoft have entered into a new long-term strategic partnership to architect LSEG's data infrastructure using the Microsoft Cloud, and to jointly develop new products and services for data and analytics. Under the arrangements, LSEG's data platform and other key technology infrastructure will migrate into Microsoft's Azure cloud environment. Workspace, LSEG's next-generation data and analytics workflow solution, will become interoperable with certain Microsoft applications and the companies plan to introduce innovative new cloud-based analytics services. LSEG and Microsoft have also agreed to explore the development of digital market infrastructure based on cloud technology, with a goal to transform how market participants interact with capital markets across a broad range of asset classes. Migration of regulated applications will be subject to applicable regulated entity board and regulator approval, prior to the relevant migration. Microsoft has agreed to purchase shares in LSEG that would result in Microsoft holding approximately a 4% equity stake in LSEG, such shares to be purchased from York Holdings II Limited and York Holdings III Limited, entities owned by certain investment funds affiliated with Blackstone, an affiliate of Canada Pension Plan Investment Board, an affiliate of GIC Special Investments Pte. Ltd, and by Thomson Reuters, the former Refinitiv shareholders. As a result of LSEG granting the lock-up waiver, the number of LSEG shares that the Blackstone/Thomson Reuters consortium will be able to sell between 30 January 2023 and 29 January 2024 will be unchanged and the number of LSEG shares that the Blackstone/Thomson Reuters consortium will be able to sell between 30 January 2024 and 29 January 2025 will be reduced by half of the number of shares sold to Microsoft. Microsoft has entered into a separate agreement with LSEG pursuant to which Microsoft has agreed, in addition to customary standstill and orderly marketing arrangements, to be subject to a lock-up in respect of the LSEG shares purchased by it. This will restrict any sales of such shares during the first year following completion of the share purchase, after which Microsoft shall then be restricted from selling more than half of the acquired shares during the second year following completion of the share purchase.
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| JKS | Hot Stocks05:36 EST JinkoSolar achieves maximum solar conversion efficiency of 26.4% for TOPCon - JinkoSolar announced that it has achieved a technical breakthrough for its 182 mm high-efficiency N-type monocrystalline silicon solar cell. JinkoSolar has once again set a new record, achieving a maximum solar conversion efficiency of 26.4% for its 182 mm and above large-size monocrystalline silicon TOPCon solar cell. This result has been independently confirmed by the National Institute of Metrology, China.
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| RYAN | Hot Stocks05:18 EST Ryan Specialty Group to acquire assets of Griffin Underwriting Services - Ryan Specialty announced that it signed a definitive agreement to acquire certain assets of Griffin Underwriting Services, a binding authority specialist and wholesale insurance broker headquartered in Bellevue, Washington. Griffin, founded in 1928, has relationships with retail insurance brokers both in the Pacific Northwest and across the country. Griffin offers a broad array of solutions across various specialty insurance lines, including earthquake and transportation. Griffin's technical acumen and consistent underwriting results have attracted the support of numerous leading carriers. Griffin generated approximately $23M of revenue for the 12 months ended November 30. Terms of the transaction were not disclosed. The acquisition is expected to close in January 2023.
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| CLVS NVS | Hot Stocks05:15 EST Clovis files for Chapter 11 protection, enters agreement to sell FAP-228 - Clovis (CLVS) announced that it and certain of its subsidiaries have voluntarily initiated a Chapter 11 proceeding in the United States Bankruptcy Court for the District of Delaware and will seek to sell their assets through a court supervised sales process. The debtors have filed various "first day" motions with the Bankruptcy Court requesting customary relief that will enable them to transition into Chapter 11 without material disruption to their ordinary course operations, including seeking authority to obtain debtor-in-possession, or DIP, financing and pay employee wages and benefits. In order to provide necessary funding during the Chapter 11 proceeding, Clovis has received a commitment of up to $75M in a multi-draw DIP financing facility. Upon approval by the Bankruptcy Court, the DIP financing is expected to provide Clovis with the necessary liquidity to operate in the normal course and meet obligations to its employees, vendors and customers throughout the Chapter 11 proceeding while executing on the sales process. Prior to the Chapter 11 filing, and subject to Bankruptcy Court approval, the company entered into a "stalking horse" purchase and assignment agreement with Novartis Innovative Therapies (NVS) to acquire substantially all of the rights of the company to its pipeline clinical candidate, FAP-2286, as a therapeutic agent for an upfront payment of $50M and up to an additional $333.75M upon the successful achievement of specified development and regulatory milestones and $297 million in later sales milestones. The transaction is part of a sale process under Section 363 of the Bankruptcy Code that will be subject to compliance with agreed upon and Bankruptcy Court-approved bidding procedures allowing for the submission of higher or otherwise better offers, and other agreed-upon conditions. In addition, the transaction is subject to customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. In accordance with the sale process under Section 363 of the Bankruptcy Code, notice of the proposed sale to Novartis will be given to third parties and competing bids will be solicited. The company will manage the bidding process and evaluate any bids received, in consultation with its advisors and as overseen by the Bankruptcy Court. Clovis is also actively engaged in discussions with a number of interested parties with respect to a potential sale of one or more of its other assets. Any of those sales would be subject to review and approval by the Bankruptcy Court and compliance with Bankruptcy Court-approved bidding procedures.
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| NOK | Hot Stocks05:10 EST Nokia, O2 Telefonica Germany aggregate sub-6 GHz spectrum frequencies - Nokia and O2 Telefonica Germany announced that they have successfully aggregated sub-6 GHz spectrum frequencies in an industry-first two-component carrier uplink Carrier Aggregation, or CA, trial on 5G Standalone. Nokia has previously demonstrated four component carrier downlink 5G Carrier Aggregation, as well as uplink Carrier Aggregation on millimeter wave spectrum. Together with O2 Telefonica Germany, Nokia is the first to combine sub-6 GHz spectrum to boost uplink throughput.
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| RIVN | Hot Stocks05:06 EST Rivian Automotive pauses plans to produce electric commercial vans in Europe - Rivian has announced it is pausing plans to produce its electric commercial vans in Europe and will therefore no longer pursue the memorandum of understanding with Mercedes-Benz. This memorandum of understanding was signed in September. RJ Scaringe, CEO of Rivian said: "We've decided to pause discussions with Mercedes-Benz Vans regarding the Memorandum of Understanding we signed earlier this year for joint production of electric vans in Europe. As we evaluate growth opportunities, we pursue the best risk-adjusted returns on our capital investments. At this point in time, we believe focusing on our consumer business, as well as our existing commercial business, represent the most attractive near-term opportunities to maximize value for Rivian. We share the same goal as Mercedes-Benz Vans, to help the world transition to electric vehicles, and we look forward to exploring opportunities with them at a more appropriate time for Rivian."
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