Stockwinners Market Radar for November 03, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

PCOR

Hot Stocks

20:59 EDT Procore CEO sells $4.04M in common stock - In a regulatory filing, Procore disclosed that its CEO Craig Courtemanche sold 68K shares of common stock on November 1st in a total transaction size of $4.04M.
ANET

Hot Stocks

20:58 EDT Arista Networks CEO sells $3.59M in common stock - In a regulatory filing, Arista Networks disclosed that its CEO Jayshree Ullal sold 17.5K shares of common stock on November 1st in a total transaction size of $3.59M.
ASAN

Hot Stocks

18:14 EDT Asana CEO Moskovitz buys 237,015 class A shares - In a regulatory filing, Asana president, chairman and CEO Dustin Moskovitz disclosed the purchase of 237,015 class A common shares of the company on November 1 at a price of $17.50 per share.
HWEL

Hot Stocks

18:01 EDT Starton terminates combination pact withHealthwell Acquisition Corp. I - Starton Therapeutics announced that it notified Healthwell Acquisition Corp. I that the company had elected to terminate the business combination agreement among Starton, Healthwell and the other parties thereto dated as of April 27, 2023, as amended, effective immediately. The conditions to the closing of the initial business combination and subsequent amendments were not satisfied or waived by the outside date of November 3 2023. As a result, the Combination Agreement is of no further force and effect, with the exception of certain specified provisions in the Combination Agreement, which shall survive the Termination and remain in full force and effect in accordance with their respective terms. In light of the Termination, the special meeting of Starton shareholders that was initially scheduled for October 24, 2023 and subsequently adjourned will not be reconvened.
MRTX

Hot Stocks

17:59 EDT Mirati Therapeutics receives MHRA approval for KRAZATI - Mirati Therapeutics announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency granted conditional marketing authorization approval for KRAZATI as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer with KRAS mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy. "KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation. MHRA's authorization is a significant step towards improving the options available for patients and clinicians in Great Britain," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We are encouraged by the opportunity to bring KRAZATI, a potential best-in-class treatment to qualified patients."
SCU RITM

Hot Stocks

17:43 EDT Sculptor says ISS, Glass Lewis urge holders to vote for Rithm Capital merger - Sculptor Capital Management Inc. (SCU) announced that leading proxy advisory firms Institutional Shareholder Services and Glass Lewis & Co. recommend that Sculptor stockholders vote "FOR" its proposed merger with Rithm Capital Corp. (RITM) at Sculptor's special meeting of stockholders to be held on November 16, 2023. Marcy Engel, Chair of the Board of Directors of Sculptor, stated, "We are pleased that the two leading proxy advisory firms, ISS and Glass Lewis, have recommended that stockholders vote "FOR" our proposed transaction by Rithm, which will deliver immediate and certain value for stockholders. We urge Sculptor stockholders to vote in favor of this compelling transaction at the Special Meeting on November 16, 2023."
AMZN

Hot Stocks

17:42 EDT Amazon.com exec Herrington sells 4,000 common shares - In a regulatory filing, Amazon CEO of Worldwide Amazon Stores Douglas Herrington disclosed the sale of 4,000 common shares of the company on November 1 at a price of $133.98 per share.
BAESY

Hot Stocks

17:36 EDT BAE Systems awarded $211.48M Navy contract modification - BAE Systems was awarded a $211.48M firm-fixed-price modification to a previously awarded contract for Amphibious Combat Vehicles, or ACV. The total cumulative face value of the contract is $2.55B. This contract modification provides for the exercise of options for the procurement of 40 full rate production ACV Personnel variants and associated production, fielding and support costs, and support & test equipment. Work has an expected completion date of February 2026. FY24 procurement funds in the amount of $211.48M will be obligated at the time of award and will not expire at the end of the current fiscal year. Marine Corps Systems Command is the contracting activity.
OSK

Hot Stocks

17:33 EDT Oshkosh awarded $208.89M Army contract modification - Oshkosh was awarded a $208.89M modification to a contract for Joint Light Tactical Vehicles. Work has an estimated completion date of September 25, 2025. FY23 Air Force European Deterrence Initiative funds; FY23 and FY24 procurement, Air Force funds; FY23 and FY24 procurement, Marine Corps funds; and FY24 other procurement, Army funds in the amount of $208.89M were obligated at the time of the award. U.S. Army Corps is the contracting activity.
WE

Hot Stocks

17:13 EDT Cole Capital proposal seeks to acquire 51% of all minority shares of WeWork - Cole Capital Funds sent the following letter to the Board of Directors of WeWork: "We believe that it is in the best interest of WeWork to support our acquisition of 51% of all the outstanding shares owned by minority shareholders at a price of $9.00 per share and provide Cole with proper representation on the company board. We have received feedback from City National Bank and JP Morgan regarding the financing for this acquisition and expect to select a lender and have a financing commitment prior to execution of a definitive agreement. We have consulted with God, legal, financial and other advisors to assist us with this transaction. We stand ready to proceed timely. In addition, we have evaluated WeWork's current locations and have evaluated several new locations which we believe will add to an expanded WeWork community. Our vision for the company involves a significant expansion of the offerings available to the growing WeWork community, including additional properties which are under consideration in markets across the United States. We will design these new facilities to be attractive to a broader customer base. These include but are not limited to our armed forces veterans, our country's expansive traveling healthcare providers, traveling sales forces, and the expansive marine industry via new and enhanced facilities and strategic partnerships. Most importantly we want to usher WeWork back to its roots so that members are part of an interacting community and not just a person renting a desk. We believe that a significant number of the stockholders would be supportive of a transaction of the nature described in this letter. In light of the sluggish stock price and the pending loan defaults it is imperative to engage in meaningful discussions regarding this transaction immediately. In addition, in order to deliver maximum stockholder value, we believe that our proposed price of $9.00 per share, representing a $7.89 per share premium over WeWork's last closing price of $1.11 per share as of November 2, 2023 is generous. We believe that this all-cash offer is compelling for WeWork and its stockholders and, accordingly, we are making this letter public simultaneously with its delivery to you."
TMUS

Hot Stocks

17:10 EDT T-Mobile exec Ewaldsson sells 20,000 common shares - In a regulatory filing, T-Mobile president of technology Ulf Ewaldsson disclosed the sale of 20,000 common shares of the company on November 1 at a price of $144.02 per share.
LGIH

Hot Stocks

17:08 EDT LGI Homes reports 560 home closings in October - LGI Homes announced it closed 560 homes in October 2023, up from 532 homes closed in October 2022, representing year-over-year growth of 5.3%. As of October 31, 2023, the company had 108 active selling communities.
LUMN

Hot Stocks

16:35 EDT Lumen CEO Johnson acquires 1M common shares - In a regulatory filing, Lumen Technologies president and CEO Kathleen Johnson disclosed the purchase of 1M common shares of the company on November 2 at a price of 97c per share.
SCNI

Hot Stocks

16:33 EDT Scinai Immunotherapeutics receives Nasdaq letter over noncompliance - Scinai Immunotherapeutics announced receipt of a letter from the Nasdaq Stock Market dated November 1, 2023, regarding non-compliance with the requirement to maintain a minimum bid price of $1.00 per share. The November 1st letter indicates that, based on the closing bid price of the company's ADSs for the last thirty-three consecutive business days, the company does not meet this requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company has been provided an initial period of 180 calendar days to regain compliance. The letter states that the Nasdaq staff will provide written confirmation that the company has achieved compliance with Rule 5550(a)(2) if at any time before the 180-day period ends on April 29, 2024, the closing bid price of the company's ADSs is at $1.00 per share or more for a minimum of ten consecutive business days. Scinai intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement. The November 1st letter is in addition to the previously disclosed receipt of deficiency letter dated May 1, 2023, from Nasdaq notifying the company that it is not in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market.
FSR

Hot Stocks

16:32 EDT Fisker names David King CTO - Fisker announced that David King has been promoted to Chief Technology Officer. King will immediately assume his new role, replacing Dr. Burkhard Huhnke, who is leaving the company for personal reasons. King joined Fisker in 2021 after three decades in the auto industry. As Fisker's SVP - Engineering, he previously headed up global Body Engineering, where he oversaw the development and launch of the Ocean body program in Graz, Austria at Fisker's manufacturing facility. King also supervised UK operations and led Fisker Magic Works, the company's special vehicle division. In this position, he has been leading the development of the Fisker Rundefinednin super GT convertible and the Force-E offroad package for the Fisker Ocean. As CTO, he will report to Chairman and CEO Henrik Fisker and will lead Fisker's global engineering and software teams in the US, Europe, India and China.
ARHS

Hot Stocks

16:31 EDT Arhaus welcomes new showroom in Huntington Station, NY - Arhaus announced the opening of its new 12,263 square-foot showroom in Huntington Station, New York. Nestled within Walt Whitman Shops in Suffolk County on Long Island, Arhaus promises a haven of high-quality furniture and home decor, set amidst the backdrop of the center's diverse lifestyle offerings, from shopping to dining and more. This showroom marks the brand's fourth in New York alongside locations in Rochester, Roslyn and White Plains.
CHE

Hot Stocks

16:16 EDT Chemed CFO David Williams to retire - After more than three decades, Executive Vice President and Chief Financial Officer David P. Williams has announced that he will retire as Chemed's Chief Financial Officer as of December 31, 2023, but Williams will continue to work with Chemed for the transition period and beyond in providing his guidance and the benefit of his expertise to the executive team and the Board of Directors. "It has been a privilege to work with David as an integral part of our management team for these last three decades," said Chemed Chief Executive Officer, Kevin McNamara. "David has done a fantastic job building and leading our financial organization and is leaving it very well-positioned to move forward."
GEHI

Hot Stocks

16:10 EDT Gravitas Education updates date for special dividend - Gravitas Education announced that, further to its announcement regarding the payment of a special dividend dated September 21, the company expects that the special dividend will be paid on or before the 21st day after the date of the closing to shareholders of record at the close of business in the Cayman Islands and holders of American depositary shares at the close of business in New York on November 14. The company expects the date of the closing to be on or after November 15, subject to the satisfaction of certain closing conditions and regulatory approval related to the merger. The special cash dividend to be paid ranges from $5.628 to $6.085 per ADS, or from $0.5628 to $0.6085 per ordinary share. The aggregate amount of cash dividends to be paid ranges from US$16 million to $17.3M.
SNSE

Hot Stocks

16:05 EDT Sensei Biotherapeutics reports 'favorable' clinical data for SNS-101 - Sensei Biotherapeutics reported initial data from the monotherapy dose-escalation portion of its Phase 1/2 clinical trial for SNS-101, a conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). The data, to be presented in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, suggest a potential best-in-class safety and pharmacokinetic profile among VISTA blocking antibodies and the potential to overcome long-standing pharmacological challenges encountered by first generation approaches to blocking VISTA. "We are pleased to report favorable clinical data for SNS-101, a pioneering VISTA-blocking antibody that provides validation of our conditionally active approach. The data support that this highly innovative antibody is well tolerated across dose levels tested to date, shows linear, dose-dependent pharmacokinetics predicted preclinically to elicit immune-mediated anti-tumor activity, and a cytokine profile consistent with an absence of cytokine release syndrome," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Data from this clinical study to date provides important initial evidence that SNS-101 can provide clinically meaningful and mechanistic differentiation from first generation anti-VISTA approaches, as indicated by SNS-101 dose levels that are at least 10 times higher than the first clinical study of a competitor VISTA antibody that was prematurely halted due to cytokine release syndrome and poor pharmacokinetics. We believe this represents a foundational clinical achievement in the pursuit of a transformational VISTA-blocking antibody, and we look forward to building on this success with additional data readouts, including efficacy analysis, expected next year."
SRRK

Hot Stocks

16:03 EDT Scholar Rock presents new data from Phase 1 DRAGON trial - Scholar Rock announced new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selective inhibitor of latent TGFbeta1 activation being developed with the aim of overcoming resistance to checkpoint inhibitor therapy in patients with advanced cancer. These data will be presented in two poster presentations during the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting & Pre-Conference being held November 1 - 5th in San Diego. The first poster focuses on the safety, efficacy, and preliminary biomarker data in patients with anti-PD-1 resistant clear cell renal cell carcinoma (ccRCC) in Part A2 (dose escalation) and Part B (dose expansion) of the Phase 1 DRAGON trial. The ccRCC cohort was the focus for that poster, as it was the fastest cohort to achieve enrollment goals. The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types. Data presented continues to support proof of concept for SRK-181 in 28 heavily pretreated patients with ccRCC resistant to anti-PD-1. SRK-181 was generally well tolerated and showed promising anti-tumor activity in this patient population. Of 28 evaluable patients in the ccRCC cohort, six patients treated with SRK-181 in combination with pembrolizumab had confirmed partial responses (PRs) and achieved a best tumor reduction of 33% to 93%, with an objective response rate (ORR) of 21.4%. In the biomarker analysis for ccRCC, levels of circulating granulocytic myeloid-derived suppressor cells (gMDSC) correlated with clinical activity in ccRCC patients treated with SRK-181 in combination with pembrolizumab. The data cutoff for all analyses was August 29, 2023.
ICCM

Hot Stocks

16:01 EDT IceCure Medical receives Nasdaq minimum bid price notification - IceCure Medical announced that it has received a written notice from Nasdaq Stock Market LLC indicating that the company is not in compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), the company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Notice has no immediate effect on the company's Nasdaq listing or the trading of its ordinary shares and during the grace period, as may be extended, the company's ordinary shares will continue to trade on the Nasdaq Capital Market under the symbol "ICCM".
PLM GLNCY

Hot Stocks

15:14 EDT PolyMet receives final order for arrangement with Glencore - PolyMet Mining (PLM) announced that the Supreme Court of British Columbia has granted the final order in connection with the previously announced statutory plan of arrangement under Part 9, Division 5 of the Business Corporations Act involving the company and Glencore AG (GLNCY). Pursuant to the Arrangement, Glencore will acquire the approximately 17.82% of the issued and outstanding common shares of PolyMet that Glencore did not already own for $2.11 in cash, per Minority Share. As announced in its news release dated November 1, 2023, the Arrangement was approved by the holders of common shares of the company at a special meeting of the Shareholders held on November 1, 2023. The Arrangement is expected to be completed on or about November 7, 2023, subject to the delivery by the parties of customary closing deliverables.
VUZI

Hot Stocks

14:42 EDT Vuzix says delivery completed to 'Tier-1 aerospace and defense firm' - Vuzix announced it has completed delivery against a follow-on order from "a Tier-1 aerospace and defense contractors with which it has been working with." Vuzix added that the company "expects to receive additional orders in subsequent phases with this partner."
PCT

Hot Stocks

14:03 EDT PureCycle Technologies makes first commercial shipment to Formerra - PureCycle Technologies said it sent out its first truckload of Ultra-Pure Recycled resin. This first shipment of PureFive will be delivered to Formerra, an engineered materials distributor. Formerra is the primary authorized North American distributor of PureCycle's UPR resin, PureFive. "This is a turning point for the future of PureCycle," said PureCycle CEO Dustin Olson. "We have built a strong partnership with Formerra and it's exciting to now provide them with this first truckload of PureFive. We look forward to their continued help in bringing our game-changing product to the market." Olson added, "This first shipment of resin will provide customers with a no-compromise solution and help them meet both the challenging technical requirements and their sustainability goals. This is an exciting new phase for PureCycle in our quest to create a Pure Planet."
AMKBY

Hot Stocks

13:44 EDT AP Moller Maersk to reduce global workforce to below 100,000 positions - AP Moller Maersk said that it has imposed rigorous cost containment measures during the year to effectively cushion the impact of the challenging market conditions, including headcount reduction from 110,000 early 2023 to around 103,500 today. Given the worsening price outlook in Ocean, Maersk is intensifying those measures and today introduce plans to further decrease the workforce by 3,500 positions, with up to 2,500 to be carried out in the coming months and the remaining to extend into 2024. This will reduce the global workforce to below 100,000 positions. Accordingly, total expected restructuring charge is now expected at $350M, up from $150M announced in February. The adjustment of the workforce complements the decisive actions taken on cost containment throughout the year. The accumulated effect will bring down Maersk's selling, general and administrative expenses cost by $600M for 2024. In addition, CAPEX spend has been adjusted downward for 2023 and 2024 and further measures are under review, including the continuation of the share buyback program into 2024. Guidance for 2024 will be given on 8 February 2024, as part of the release of the Annual Results.
BAC...

Hot Stocks

13:14 EDT Federal Reserve says ACH error impacting customers - The Federal Reserve stated in a system status notice dated November 03, 2023 12:44 PM Eastern Time: "On November 3, 2023, a processing issue at EPN, the private sector ACH operator, resulted in a number of ACH entries having certain data elements obscured - file dated for November 1, 2023, processed on November 2, 2023, with effective dates from November 2-3. This error was contained in a single interoperator file that was distributed by EPN to its participants during the November 2 6:00 p.m. processing window. These entries contain valid Nacha syntax, but obscured account information and recipient information. EPN has informed us that these items are not able to be processed by receiving depository financial institutions, or RDFIs, because of the obscured data. EPN has instructed its participants to initiate returns, and originating depository financial institutions, or ODFIs, will need to be prepared to initiate new items to complete the payments." Customers at Bank of America (BAC), JPMorgan Chase (JPM), US Bank (USB), Truist (TFC) and Wells Fargo (WFC) have complained of issues on Friday morning, according to CNN, citing data from Downdetector. Reference Link
BKR

Hot Stocks

13:01 EDT Baker Hughes reports U.S. rig count down 7 to 618 rigs - Baker Hughes reports that the U.S. rig count is down 7 from last week to 618 with oil rigs down 8 to 496, gas rigs up 1 to 118 and miscellaneous rigs unchanged at 4. The U.S. Rig Count is down 152 rigs from last year's count of 770 with oil rigs down 117, gas rigs down 37 and miscellaneous up 2. The U.S. Offshore Rig Count is down 3 to 21, up 7 year-over-year. The Canada Rig Count is unchanged from last week at 196, with oil rigs unchanged at 122, and gas rigs unchanged at 74. The Canada Rig Count is down 13 from last year's count of 209, with oil rigs down 19, and gas rigs up 6.
CGEM

Hot Stocks

12:30 EDT Cullinan Oncology to present data across immunotherapy pipeline - Cullinan Oncology will present data across four distinct immuno-oncology programs in five poster presentations at the Society for Immunotherapy of Cancer 2023 Annual Meeting taking place November 1-5 in San Diego. Title: Characterization of the pharmacodynamic activity of CLN-619, an anti-MICA/B monoclonal antibody, in patients from an ongoing Phase 1 trial: Initial clinical biomarker data demonstrates that CLN-619 increases MICA expression on the tumor cell surface, consistent with previously reported preclinical data and supporting the proposed mechanism of action. Data from patients with available biopsy data demonstrate clinical benefit, including objective response, in patients with tumors with characteristics not typically responsive to checkpoint inhibitor therapy. Specifically, tumors from two patients with endometrial cancer and previously reported confirmed partial responses were microsatellite stable, had low tumor mutational burden, and low neoantigen presentation index. Available biopsies from patients with prolonged stable disease showed similar low mutational burden and neoantigen presentation index characteristics, as well as increased surface MICA/B expression and NK cell activation.
XNCR

Hot Stocks

12:28 EDT Xencor presents preclinical data from XmAb research programs - Xencor presented data from multiple preclinical-stage XmAb programs at the 38th Annual Meeting of the Society for Immunotherapy of Cancer in San Diego. Abstract 764, "A Phase 1, first-in-human, open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors" Xencor is conducting a Phase 1 study of XmAb808 in patients with advanced solid tumors. XmAb808 is a tumor-selective, co-stimulatory XmAb 2+1 bispecific antibody designed to bind to the broadly expressed tumor antigen B7-H3 and selectively to the CD28 T-cell co-receptor only when bound to tumor cells, which was demonstrated in vitro. Strong potentiation of checkpoint and CD3 cytotoxic activity was also observed in vivo. XmAb808 is a wholly owned Xencor program. The clinical trials in progress poster reviews the design of XmAb808 and the rationale of using CD28 bispecific antibodies to expand the utility of checkpoint blockade and CD3 T cell engagers. The poster also provides study objectives, key eligibility criteria and study schema. Preclinical Programs: Abstract 1060, "Optimally engineered IL18-Fc fusion proteins balance potency and pharmacokinetics to promote strong anti-tumor activity" IL-18 is a proinflammatory cytokine that modulates both the innate and adaptive immune responses. Preclinical studies of IL-18 have demonstrated its anti-tumor activity, including synergy with immune checkpoint inhibitors and CAR-T therapies. In contrast with other potent cytokines, IL-18 has been well tolerated in clinical trials but demonstrated a lack of efficacy despite heavy dosing. IL-18 induces a negative feedback loop with its high affinity natural inhibitor, IL18BP, which was upregulated in early phase clinical studies and may have limited IL-18's clinical performance. Xencor engineered stabilized, potency-modulated IL-18 cytokines fused to an XmAb heterodimeric Fc domain with Xtend Fc technology for longer half-life. In addition, Xencor engineered bispecific IL18-Fc cytokines targeted to PD-1, a checkpoint receptor on T cells. Importantly, these molecules were engineered to avoid binding IL18BP. Xencor's IL18-Fc fusions and PD1 x IL18-Fc bispecific inhibited tumor growth in a dose- and potency-dependent manner, outperforming a wild-type IL18-Fc fusion, in vivo. Further preclinical studies of the engineered IL18-Fc fusions demonstrated pharmacodynamic profiles similar to wild-type IL18-Fc. Notably, a set of surviving tumor-engrafted mice, which had previously received engineered IL18-Fc fusions, had no tumor growth upon rechallenge. Abstract 1193, "Synergistic targeting of multiple activating pathways with Natural Killer cell Engagers": Xencor's XmAb natural killer cell engagers are multifunctional antibodies that target multiple activating receptors on the surface of NK cells and bind to tumor-associated antigens. MICA and MICB are stress-induced tumor antigens expressed in a range of cancers. MICA/B antigens are recognized by NKG2D, an activating receptor on NK and CD8+ T cells. While membrane-bound, MICA/B is immuno-stimulatory; however, the cleaved and soluble form, found in the tumor microenvironment, prevents NKG2D from recognizing tumor cells. Xencor engineered anti-MICA/B antibodies with enhanced effector function in order to block the cleavage of MICA/B antigens and promote NK cell engagement. These antibodies increased MICA/B membrane surface density and led to tumor cell killing with MICA/B binding to NKG2D on immune cells. To enhance the anti-tumor activity, Xencor engineered multi-specific NK cell-engaging antibodies that simultaneously target MICA/B antigens and an orthogonal activating receptor on NK cells, NKp46. These multi-specific NK cell-engaging antibodies demonstrated enhanced functional activity compared to the antibodies targeting only MICA/B.
TBIO

Hot Stocks

12:25 EDT Telesis Bio announces commercial release of cell-free amplification kit - Telesis Bio announced the commercial release of its BioXp De novo Cloning and Amplification kit on the BioXp 3250 and BioXp 9600 systems. This cell-free DNA amplification kit provides an efficient automated solution for building and amplifying DNA constructs to transfection-scale quantities in researchers' labs by skipping tedious bacterial scale-up and eliminating unpredictable service provider delivery times. The new kit will provide a robust and reliable solution to progress from sequence to functional screening in days instead of weeks, empowering researchers in iterative discovery applications such as antibody hit-to-lead screening and protein engineering to streamline and control their workflow timelines.
KRRO FREQ

Hot Stocks

12:25 EDT Korro Bio, Frequency announce merger closing, private placement - Korro Bio announced the completion of the previously announced business combination between Frequency Therapeutics (FREQ) and the entity formerly known as Korro Bio. The combined company will operate under the name Korro Bio and its shares are expected to begin trading on the Nasdaq under the ticker symbol "KRRO" on November 6. Immediately prior to the merger, Korro completed the previously announced $117M private placement co-led by Surveyor Capital and Cormorant Asset Management with participation from Eventide Asset Management, Atlas Venture, NEA, Invus, Point72, Platanus, Qiming Venture Partners USA, MP Healthcare Venture Management, Verition Fund Management, Monashee Investment Management, Sixty Degree Capital and additional investors. Following consummation of the transactions, Korro's cash, cash equivalents and investments of approximately $170M, after transaction expenses, are expected to fund operations and multiple potentially value-creating milestones into 2026, including advancing its lead product candidate in AATD through a clinical milestone, progression of additional product candidates from the pipeline into the clinic, and demonstrating applicability of the RNA editing platform into several additional tissue types.
CADL

Hot Stocks

12:24 EDT Candel Therapeutics announces initial data from Phase 2 trial of CAN-2409 - Candel Therapeutics announced initial positive interim survival and immunological biomarker data from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir together with standard of care chemoradiation followed by resection for borderline resectable pancreatic ductal adenocarcinoma. Data were presented today in a poster session titled 'Neoadjuvant CAN-2409+Prodrug Plus Chemoradiation for Borderline Resectable or Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma at the 2023 Society for Immunotherapy Annual Meeting. Data Highlights as of August 21, 2023 Data Cutoff, include: Prolonged and sustained survival was observed after experimental treatment with CAN-2409 plus prodrug in patients with borderline resectable PDAC; An estimated survival rate of 71.4% at both 24 and 36 months, observed in patients who received CAN-2409 regimen together with SoC chemoradiation prior to surgery, versus only 16.7% survival at 24 and 36 months in patients with SoC chemoradiation prior to surgery.; Importantly, 5 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with two patients surviving more than 45 months from enrollment. Only one patient randomized to control SoC chemotherapy remained alive at data cut-off; Median overall survival has not yet been reached in patients who received CAN-2409; median overall survival was 12.5 months in the control arm. Disease course was altered after salvage chemotherapy with improved CA19-9 levels and ongoing survival in CAN-2409 arm, but not in control arm. Data showed consistent and robust activation of immune response after dosing with CAN-2409; In pancreatic tissue of patients treated with CAN-2409 plus prodrug together with SoC, dense aggregates of CD8+ granzyme B positive cytotoxic T cells, dendritic cells, and B cells were observed in the tumor microenvironment.; Increased levels of soluble granzymes B and H as well as pro-inflammatory cytokines, including IFN-gamma, were observed in peripheral blood after CAN-2409 treatment, but not with control treatment. CAN-2409 was associated with a favorable tolerability profile; Addition of CAN-2409 regimen to SoC was generally well tolerated, with no reported dose-limiting toxicities, including no cases of pancreatitis.
DXPE

Hot Stocks

12:24 EDT DXP Enterprises completes acquisition of Alliance Pump & Mechanical Service - DXP Enterprises announced the completion of the acquisition of Alliance Pump & Mechanical Service, a municipal and industrial pump sales, service, and repair company. DXP funded the acquisition with cash on the balance sheet. David R. Little, Chairman, and CEO remarked, "We are pleased to welcome the Alliance employees to the DXP team. Alliance is a unique, well-run business focused on providing value-added service and repair capabilities to its customers. Alliance will provide DXP with additional geographic territory and enhanced end market mix. Alliance is a great company with key differentiators and provides us with high caliber people."
RAPT

Hot Stocks

12:23 EDT Rapt Therapeutics reports 'positive' data from Phase 2 FLX475 combo trial - Rapt Therapeutics announced safety and efficacy data from its Phase 2 trial of FLX475 in patients with advanced non-small cell lung cancer who had no prior checkpoint inhibitor therapy. The trial evaluated FLX475, an oral small molecule CCR4 antagonist designed to block the migration of regulatory T cells, in combination with the checkpoint inhibitor pembrolizumab. In this cohort of NSCLC patients, 36 patients were evaluable for efficacy, of which 20 were PD-L1 positive. In these PD-L1 positive patients, the combination of FLX475 and pembrolizumab showed a 40% (8/20) confirmed ORR and a median PFS of 6.3 months as of the data cut off date, with seven patients continuing on study. For comparison, historical pembrolizumab monotherapy activity in checkpoint inhibitor-naive and previously-treated NSCLC patients showed a confirmed ORR of 18% and a median PFS of 4.0 months. The confirmed ORR for the combination of FLX475 and pembrolizumab in PD-L1 low and high subsets were 38% and 50%, respectively. For comparison, the ORR for pembrolizumab monotherapy in the PD-L1 low and high subsets has been previously reported as 10% and 30%, respectively. The data were presented today in a poster at the Society for Immunotherapy of Cancer 38th Annual Meeting being held in San Diego. The presenting author was Julie Brahmer, M.D., Co-director of the Upper Aerodigestive Department and Professor of Oncology, Johns Hopkins University. "We are excited by the response rates and PFS data for FLX475 in combination with a checkpoint inhibitor in this cohort of NSCLC patients. The data from this cohort, which will continue to mature and potentially improve, met our criteria to advance development of FLX475," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT. "We are particularly intrigued to see differentiating efficacy in patients with cool (PD-L1 low) tumors, which are typically poorly responsive to checkpoint inhibitors and checkpoint inhibitor combinations, such as those with anti-TIGIT antibodies. Along with RPT193, we now have two internally discovered compounds that have demonstrated clinical proof of concept in large, commercially attractive indications."
INKT

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12:22 EDT MiNK Therapeutics presents clinical activity of allogeneic iNKT cells - MiNK Therapeutics presented new agenT-797 data in solid tumor cancers at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting. Single administration of agenT-797 alone or in combination with anti-PD-1 delivered clinical benefit in heavily pre-treated patients with solid tumors. Phase 1 trial of agenT-797 alone or in combination with pembrolizumab or nivolumab without lymphodepletion showed durable clinical benefit, including: Clinical response in MSI-high 3L gastric cancer patient after failure on pembrolizumab and nivolumab/FOLFOX. :ong-term disease stabilization, including in testicular cancer and anti-PD-1 relapsed/refractory non-small-cell lung cancer. Tolerable safety profile with no dose-limiting toxicities and no grade greater than3 neurotoxicity or cytokine release syndrome. AgenT-797 showed long-term persistence and induced a potent anti-tumor response, including increased infiltration of cytotoxic immune cells into tumors. AgenT-797 was detected in the periphery for up to 6 months and persistence was independent of HLA matching. An increased level of immune cell tumor infiltration and neoantigen driven expansion of anti-tumor cytotoxic T cells was observed following administration. AgenT-797 promoted a systemic and local pro-inflammatory cytokine signature. Expansion of clinical programs are underway in additional solid tumor settings, including relapsed/refractory gastric cancer. Expected launch of a randomized phase 2 trial in 2L gastric cancer, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, by year-end 2023. The study will evaluate agenT-797 in combination with standard of care chemotherapy +/- Agenus' botensilimab/balstilimab combination. Expansion of phase 1 study underway to evaluate further signals in select tumor types, including non-small cell lung cancer and testicular cancer, and evaluate multi-dosing of agenT-797.
ADAG

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12:21 EDT Adagene presents data on ADG126 at SITC Annual Meeting - Adagene presented new data on its masked, anti-CTLA-4 SAFEbody ADG126 at the Society for Immunotherapy of Cancer 38th Annual Meeting taking place in San Diego. The poster presentation, Optimal Dose Selection of ADG126 with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling, is available on the company's website. The data, which integrate clinical results with physiologically based pharmacokinetic and quantitative systems pharmacology modeling, demonstrated that Adagene's lead SAFEbody candidate, ADG126, is effective at targeting CTLA-4 within the tumor microenvironment. This resulted in an approximately 30-fold projected pharmacokinetic difference at 10 mg/kg every three weeks in the TME indicating a wider therapeutic index compared to ipilimumab at 1 mg/kg Q6W, when either is combined with anti-PD-1 therapies. Importantly, a clinical case example presented for the first time from an ongoing dose expansion cohort in advanced/metastatic MSS CRC patients free of liver metastases showed that ADG126 10 mg/kg Q3W plus pembrolizumab resulted in a confirmed PR after four cycles. The patient was previously treated with two lines of therapy and experienced manageable Grade 3 TRAEs consistent with known adverse events from immunotherapy. The poster concluded that initial clinical data from the SAFEbody ADG126 program support that ADG126 may provide greater clinical benefit than ipilimumab in combination with anti-PD-1 in both 'hot' and 'cold' tumors, including MSS CRC, driven by better target engagement in the TME and a favorable safety profile that enables higher, more frequent and repeat dosing.
IMMP

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12:20 EDT Immutep announces new biomarker data from TACTI-002 Phase II - Immutep announces new biomarker data from the TACTI-002/KEYNOTE-798 Phase II trial evaluating eftilagimod alpha, a soluble LAG-3 protein and first-in-class MHC Class II agonist administered subcutaneously, in combination with MSD's anti-PD-1 therapy KEYTRUDA as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer. The biomarker data related to blood samples from TACTI-002 patients presented at the Society for Immunotherapy of Cancer Annual Meeting 2023 substantiates efti's unique immune system stimulation and can be linked to its success in first line treatment of metastatic NSCLC patients, including the positive Overall Survival results recently reported at ESMO Congress 2023. Sustained and significant increase of interferon-gamma and C-X-C motif chemokine ligand 10 serum biomarkers for systemic Th1 response were seen at three months and six months on-therapy. Among patients with a partial or complete response, 86% showed a greater than or equal to1.4-fold change of IFN-gamma and 100% showed a greater than or equal to1.4-fold change CXCL10, after the first efti dosing. Additionally, the early increase of absolute lymphocyte count (ALC) was significantly greater in patients that experienced a clinical benefit, and is a potential on-treatment biomarker for response to this therapy. Furthermore, blood-based gene expression profiling analyses revealed significant enrichment of genes involved in immune activation and cytotoxicity, including CD8 T cells, in patients with a favourable tumor response. This biomarker data from the TACTI-002 Phase II is similar to the biomarker analysis from Immutep's randomized, double-blind AIPAC Phase IIb trial in HER2-/HR+ metastatic breast cancer, which combined efti solely with paclitaxel chemotherapy and did not include any anti-PD-1 therapy. In that trial, the number of circulating immune cells and CXCL10 serum levels with efti increased in a statistically significant fashion compared to baseline. The increase in pharmacodynamic markers, including ALC and CD8 T Cells, were also significantly linked to improved overall survival in the efti group.
MOLN

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12:18 EDT Molecular Partners present updated data from Phase 1 trial of MP0317 - Molecular Partners will present additional positive data from its Phase 1 study of MP0317 in patients with advanced solid tumors at the 2023 Annual Meeting of the Society for Immunotherapy of Cancer, being held November 1-5 in San Diego, California. MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironmen by anchoring to fibroblast activation protein. This update, based on data from 46 patients, corroborates earlier reported findings of MP0317-induced CD40 activation and related remodeling of the TME. The detection of MP0317 in tumor biopsies is associated with an increase in CD40-mediated re-programming of immune cells illustrated by IFNg production and dendritic cell maturation within the TME. Elevation of serum levels of CXCL10, an effector chemokine downstream of IFNg signaling, and changes in soluble biomarkers post-MP0317 treatment support these findings. To date, one patient achieved a partial response and stable disease was observed in eight additional patients. MP0317 continues to display a favorable safety profile across all dosing cohorts, with limited systemic inflammation-related adverse reactions compared to other CD40 agonists. Dose-limiting toxicity was reported in only one patient to date, at the highest planned MP0317 dose of 10 mg/kg administered Q3W. The positive results of this fully enrolled Phase 1 study in patients with refractory/relapsed tumors support continued clinical evaluation of MP0317 and potential investigation in combination studies. The Company expects to share final results of this study in 2024. This ongoing first-in-human Phase 1, open-label, dose-escalation study assesses the safety and tolerability as well as pharmacokinetics/pharmacodynamics and preliminary antitumor activity of MP0317 monotherapy in patients with advanced solid tumors known to express FAP and CD40. Recruitment for the dose-escalation portion of the study is complete, with 46 patients enrolled in the Netherlands and France across nine dosing cohorts. Patients received MP0317 at doses of 0.03-10 mg/kg in every-3-weeks or weekly schedules.
PHIO

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12:16 EDT Phio Pharmaceuticals presents preclinical data on INTASYL compound - Phio Pharmaceuticals Corp. announced the presentation of new preclinical data at the 38th Annual Meeting of the Society for Immunotherapy of Cancer. The event is scheduled to take place in San Diego, California, from November 1-5, 2023. Phio's innovative preclinical study data highlights the benefit of intratumoral injection of an INTASYL compound targeting CTLA-4 in conjunction with systemic anti-PD-1 antibody therapy. Preclinical studies have demonstrated: The combination of INTASYL compound 27790 with systemic anti-PD-1 antibody therapy significantly enhanced the efficacy of anti-PD-1 mAb therapy in vivo. The combination of INTASYL compound 27790 and anti-PD-1 elicited complete regression of ~40% of IT treated tumors in a mouse model. Additionally, INTASYL compound 27790 appeared to improve the efficacy of anti-PD-1 therapy toward those tumors not treated directly with 27790. INTASYL compound 27790 increased the percentage of reactive CD8+ T cells in the tumor while decreasing immunosuppressive/pro-tumor macrophages in the treated tumor micro-environment.
CDTX

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12:15 EDT Cidara Therapeutics presents preclinical data on CBO421 - Cidara Therapeutics announced new preclinical data on its drug-Fc conjugate candidate, CBO421, at the Society for Immunotherapy of Cancer's 38th Annual Meeting. The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA. "We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we're excited to advance this candidate into clinical trials for the treatment of solid tumors."
LINC

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12:14 EDT Lincoln Educational signs lease deals for future Houston, Nashville campuses - Lincoln Educational Services Corporation announced two major advances as part of its strategic growth plan. The first is an expansion into a new market with the leasing of a facility in Houston, TX, the country's fourth largest employment market. The second is the completion of a lease agreement for the relocation of the Nashville, TN campus. Both facilities will provide industry-supported career training programs to help prepare students for careers in some of the country's fastest-growing hands-on fields while continuing Lincoln's efforts to solve the skills gap faced by so many American companies. These announcements come as Lincoln nears the buildout completion of its new campus in Atlanta, GA, which is scheduled to begin instruction in the first half of 2024, as well as the recently announced facility purchase to relocate its Philadelphia, PA campus to a larger facility in Levittown, PA in the first half of 2025. "When we announced last summer our plan to strategically establish multiple new campuses in the next few years, we knew it would be a bold, aggressive initiative," says Scott Shaw, Lincoln Tech's President and CEO. "At the same time, we've selected these locations because our research shows that they are underserved in terms of opportunities for individuals wanting to train for rewarding hands-on careers - the kinds of careers America depends on to keep the economy moving, and ones that can't be outsourced. We're excited to see the impact our expanded presence is going to have, not only on students seeking rewarding hands-on technical careers but on the success of the employers that so desperately want to find new talent to grow their teams."
CUE

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12:13 EDT Cue Biopharma presents data from Phase 1 trials of CUE-101 - Cue Biopharma announced the presentation of new positive data from its ongoing fully enrolled Phase 1 trials evaluating its lead interleukin-2-based T cell engager, CUE-101, as a monotherapy and in combination with KEYTRUDA for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma. New clinical data will also be reported from the company's ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms' Tumor 1 positive recurrent/metastatic cancers. The data will be presented in two posters at the Society for Immunotherapy of Cancer's 38th Anniversary Annual Meeting being held in San Diego, California and virtually November 1-5. Key data highlights from the fully enrolled CUE-101 combination expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose of 4mg/kg plus pembrolizumab, as of data cutoff of September 27 with 17 evaluable patients, include: DCR of 65% and ORR of 47%, demonstrating evidence of clinical activity in comparison to the 19% ORR observed with pembrolizumab treatment alone in the KEYNOTE-040 trial 1,2- This includes one complete response and seven partial responses, in addition to three durable stable diseases of greater than or equal to 12 weeks. 56% ORR in patients with combined positive score 1-19, in comparison to the 14% with pembrolizumab monotherapy in the KEYNOTE-040 trial 1,2, with five of the eight responses in tumors with low PD-L1 expression. 21 of the 22 patients treated with CUE-101 and pembrolizumab remain alive at time of data cutoff, including eight patients living beyond 12 months. No unanticipated, significant safety concerns have emerged, and adverse events have been readily managed with appropriate medical care. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy to date with 19 evaluable patients, include: mOS of 20.8 months in 2L+ patients treated with CUE-101 monotherapy, notably longer than the historical mOS of 7.5 and 8.4 months reported from third-party clinical trials with checkpoint inhibitors in 2L R/M HNSCC in CheckMate 1411 and KEYNOTE-040, respectively. DCR of 37% in late stage, refractory patients, including one confirmed PR of greater than 36 weeks duration and six DSD of greater than or equal to 12 weeks. Of note, one patient has maintained stable disease for over 22 months with no detectable evidence of HPV cell-free DNA in their blood after starting CUE-101 treatment and this patient recently demonstrated an unconfirmed partial response. Key data highlights from the CUE-102 Phase 1 clinical trial to date include: No DLTs reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102 intravenously every 3 weeks; a MTD has not been reached. Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reduction in tumor burden.
INAB

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12:13 EDT IN8bio presents 'positive' data from iPSC platform at SITC - IN8bio presented new positive preclinical data from its induced pluripotent stem cell gamma-delta T cell platform at the Society for Immunotherapy of Cancer's 38th Annual Meeting. The data represents a significant advance in the development of the INB-500 iPSC program towards the development of allogeneic gamma-delta T cell therapies. "Our deep understanding of gamma-delta T cell biology allows for significant ex vivo expansion capabilities," said William Ho, Co-founder and CEO. "We have successfully developed and utilized a robust serum and feeder-free process for generating iPSC derived gamma-delta T cells, representing an important step towards developing a truly allogeneic 'off-the-shelf' gamma-delta T cell source for therapeutic development." The presented data underscores the platform's ability to reprogram donor cells into iPSCs, expand them, and guide their differentiation into gamma-delta T cells through IN8bio's proprietary process, which can be scaled for full GMP manufacturing. Notably, the platform enables the differentiation into both Vd1+ and Vd2+ cell subtypes using cell-type specific processes. The iPSC-derived gamma-delta T cells underwent comprehensive characterization, encompassing morphological analysis, cell surface markers and functional assessment via tumor cell killing assays.
HOOK

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12:11 EDT Hookipa Pharma presents 'positive' biomarker, translational data on HB-200 - Hookipa Pharma announced updated Phase 1 clinical, biomarker and translational data on HB-200 as a monotherapy in heavily pretreated patients with recurrent/metastatic Human Papillomavirus 16-positive head and neck cancer. The data show HB-200 monotherapy induced robust, high-quality and durable tumor-specific T cell responses, which showed a trend of clinical benefit measured by a 44 percent disease control rate in a difficult-to-treat patient population. The data were presented in a poster presentation at the 2023 Society for Immunotherapy of Cancer Annual Meeting. "The data presented at SITC expand the body of evidence that HB-200 monotherapy has the ability to induce targeted T cells necessary for tumor control, which can translate into tumor shrinkage and encouraging clinical activity, especially in a difficult-to-treat population," said Joern Aldag, Chief Executive Officer at HOOKIPA. "As the data have matured, we have consistently delivered best-in-class T cell activation, and we continue to see the durability and functionality of tumor-specific T cells induced by HB-200. We look forward to sharing continued analyses of HB-200 across all arms of our trial in the future."
SGEN

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12:11 EDT Seagen highlights first solid tumor data for ADCETRIS combination - Seagen announced the first presentation of data evaluating ADCETRIS in combination with an anti-PD-1 checkpoint inhibitor in non-small cell lung cancer and melanoma, and shared preclinical data for an investigational CD30-directed antibody-drug conjugate that uses a novel tripeptide linker. The studies were presented at the Society for Immunotherapy of Cancer 38th Annual Meeting, taking place November 3-5, 2023, in San Diego. The Phase 2 trial SGN35-033 explored the combination of ADCETRIS with pembrolizumab in 55 patients with non-small cell lung cancer and 58 patients with melanoma who either had no response to previous anti-PD-1 treatment or who experienced cancer progression after initial response to anti-PD-1 therapy. NSCLC cohorts were evaluated using RECIST v1.1 and melanoma cohorts were evaluated using immune RECIST. In NSCLC, the ADCETRIS and pembrolizumab combination demonstrated an objective response rate of 8% and 14% in patients with primary and secondary refractory NSCLC, respectively. Disease control rates - inclusive of complete responses, partial responses and stable disease - were 67%. In melanoma, the ADCETRIS and pembrolizumab combination demonstrated an ORR of 18% and 22%, in primary and secondary refractory metastatic cutaneous melanoma, respectively. DCRs were 71% and 80%, respectively. The study design included melanoma patients who were treated in the study within 90 days of receiving prior anti-PD-1 therapy. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. Increased CD8 T cell infiltration was observed in the tumor microenvironment of patients who responded to the combination treatment, suggesting potential re-sensitization to PD-1 inhibitors. The study is currently enrolling patients in previously untreated NSCLC and head and neck cancer. SGN-35T is a next generation CD30-directed ADC that uses a novel tripeptide linker designed to preferentially release its cytotoxic payload in tumor cells to limit off-target toxicity. Preclinical data suggest that SGN-35T may be highly effective, like ADCETRIS, with the potential for improved tolerability. SGN-35T is an investigational agent, and its safety and efficacy have not been established. In this in vitro study, SGN-35T was cytotoxic to CD30-expressing tumor cells and CD30-expressing regulatory T cells, whereas CD8-expressing T cells were unaffected by SGN-35T. The observations support future clinical investigation of SGN-35T in solid tumors.
ABCL

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12:10 EDT AbCellera presents new data on two T-cell engager programs - AbCellera presented new data on its T-cell engager programs in two poster presentations at the Society for Immunotherapy of Cancer, or SITC, 38th Annual Meeting. "The data illustrate how AbCellera is leveraging its TCE platform to discover and develop immuno-oncology therapeutics for multiple tumor targets," the company stated. Bo Barnhart, Ph.D., VP of Translational Research at AbCellera, said: "Altering the affinity of either a small set of CD3-binding antibodies, or an antibody such as SP34-2, is a frequently used strategy to reduce risk of cytokine release syndrome by TCEs. However, we have demonstrated that CD3 affinity alone is not sufficient to optimize TCE function. By pairing functionally diverse CD3-binders with a wide range of tumor-binding arms, our TCE platform has identified promising bispecific molecules." Neil Aubuchon, Chief Commercial Officer at AbCellera, added: "Since launching our TCE platform in 2021, we've gained a deeper understanding of TCE biology that we believe will enable us to rapidly bring best-in-class molecules to the clinic. We look forward to applying these lessons to targets as we work towards bringing better cancer treatments to patients faster."
BCRX

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12:08 EDT BioCryst announces drug discovery updates ahead of R&D day - BioCryst Pharmaceuticals announced updates from its drug discovery process and additional therapies from its pipeline that the company will highlight at a research and development day today. The company said, "We have significantly diversified our pipeline and we continue to be disciplined around decisions to invest further only when a program meets the high bar we have set of first-in-class or best-in-class. We believe the combination of Orladeyo, our exciting pipeline and our financial strength, position us to continue to make a big difference in patients' lives, and that leads to sustainable growth for years to come." The company expects to begin clinical trials of BCX17725, a fusion protein KLK5 Inhibitor for treatment of Netherton syndrome, in 2024. For its oral C5 Inhibitor, the company expects to complete lead optimization in 2024 and begin clinical trials in 2025. It also expects to submit a U.S. supplemental new drug application for the pediatric use of Orladeyo in 2025. BioCryst's said it focus on "best-in-class or first-in-class investment criteria," and the lower investment cost of earlier stage programs, are expected to limit 2024 R&D spending to a total of between $230M and $240M across all programs. This represents an increase from projected 2023 R&D spending of $25M to $35M.
AFMD

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12:08 EDT Affimed presents poster indicating ICE improves cytotoxicity - Affimed presented a poster at the annual meeting of the Society for Immunotherapy of Cancer, indicating the company's ICE improves cytotoxicity of NK and CAR-NK cells and that NK cells redirected by ICE exhibit at least the same efficacy against tumor cells as CAR-NK cells alone or redirected by the ICE. The results emerged from a collaboration with the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany. "This is the first direct comparison of NK cells redirected by Affimed's ICE with CAR-NK cells," said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. "It is exciting to see that the combination of NK cells with ICE exhibits an anti-tumoral efficacy which is at least comparable to that of CAR-NK cells. The combination of allogeneic NK cells with ICE molecules represents the most straightforward way to generate potent and targeted NK cells. This suggests high flexibility and cost-effective manufacturing as there is no additional engineering of NK cells required." To compare approaches, the preclinical efficacy of NK cells combined with a tetravalent bispecific CD16A/CD19-targeting ICE against CD19-positive tumor cells was compared to the efficacy of anti-CD19 CAR-NK cells alone or in combination with the ICE. Cytotoxic activation was assessed by calcein-release assays, degranulation, cytokine secretion, and specific CD19-positive target cell killing. The combination of the ICE molecule with NK cells or CAR-NK cells enhanced antibody-dependent cellular cytotoxicity against tumor cells and mediated elevated levels of degranulation when compared to NK cells or CAR-NK cells alone. In conclusion, the combination of NK cells with ICE represents a straight-forward way to potently target and activate NK cells.
ONCY

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12:08 EDT Oncolytics presents 'further positive' pelareorep translational data - Oncolytics Biotech announced the presentation of a poster that "provides further positive translational data" from the previously completed AWARE-1 breast cancer window-of-opportunity study, sponsored by SOLTI-Innovative Cancer Research, at the Society for Immunotherapy of Cancer, or SITC, 38th Annual Meeting. "Using the novel IMC technology to conduct further translational data analysis from the AWARE-1 study in early-stage breast cancer patients has confirmed and expanded our understanding of pelareorep's mechanism of action in the tumor microenvironment," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We look forward to incorporating these important translational learnings into our registrational program for HR+/HER2- metastatic breast cancer. These findings likely also have implications for other indications where we have seen signals of efficacy with atezolizumab/pelareorep combinations, including pancreatic cancer in the GOBLET study focused on gastrointestinal cancers." Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, "Previously published analyses from AWARE-1 patient samples showed that in the first three days after dosing, pelareorep upregulated tumor PD-L1 expression in the tumors, induced the generation and expansion of T cell clones, and promoted the tumor infiltration of CD8+ T cells. It also led to an increase in the CelTIL score in most patients, which is a measure of tumor cellularity and immune infiltration that is associated with favorable clinical outcomes. The new IMC data presented today show an increase in cytotoxic T cells and PD-L1 expression in tumors by three days following treatment and demonstrate pela's ability to induce an enhanced immune state within tumors. This supports pelareorep's ability to modify the tumor microenvironment and enhance the responsiveness of cancers to checkpoint inhibitor therapy."
ALLO

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12:08 EDT Allogene Therapeutics presents preclinical data on allogeneic CAR T candidate - Allogene Therapeutics presented preclinical data on a novel off-the-shelf AlloCAR T product candidate targeting Claudin18.2-positive gastric and pancreatic tumors, at the Society for Immunotherapy of Cancer Annual Meeting November 1-5, 2023, in San Diego, CA. Data presented at SITC describes preclinical development of Allogene's novel allogeneic CLDN18.2 CAR T product candidate with the potential to provide clinical benefit to patients with a single, off-the-shelf infusion. CLDN18.2 has emerged as a promising therapeutic target, with high expression in many types of epithelial tumors including gastric, esophageal, pancreatic and ovarian cancers. The preclinical evaluation identified candidates with potent activity in both short-term and repeat stimulation in vitro cytotoxicity assays. The lead IND candidates researched displayed robust antitumor activity at low cell doses in vivo against both subcutaneous and intraperitoneal gastric cancer models. Data suggest the existence of a therapeutic window and the potential to target CLDN18.2 with allogeneic off-the-shelf CAR T cells without significant off tumor toxicity. These data were the foundation for ALLO-182, currently in the IND-enabling phase of development. ALLO-182 together with ALLO-213, an allogeneic CAR T targeting DLL3, represent the company's early-stage solid tumor product candidates.
ALLO

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12:06 EDT Allogene Therapeutics presents preclinical data on Cloak, Dagger tech - Allogene Therapeutics presented data highlighting the Company's next generation Cloak and Dagger technologies designed to help enhance engraftment, expansion and the persistence of AlloCAR T cell candidates, at the Society for Immunotherapy of Cancer Annual Meeting November 1-5, 2023, in San Diego, CA. The development of "off-the-shelf" CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients. However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient's immune system. Allogene's proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens. The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer cell rejection while preserving CAR T cell function. Data shown previously demonstrated that knockout of RFX5, a transcriptional regulator that controls expression of HLA molecules, enhanced survival of allogeneic CAR T cells in the presence of host T cells and elicited only minor NK cell reactivity, thereby effectively mitigating rejection. This preclinical study evaluated an additional anti-rejection approach to immune evasion by inactivating CD58 and ICAM-1, key components of the immune synapse required for effective recognition and lysis by alloreactive T/NK cells. In the study, the survival of "cloaked" cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells. The knockout of CD58 and ICAM-1 effectively reduced T cell rejection of allogeneic CAR T cells without triggering NK cell rejection or impacting effector function and worked additively with the knockout of RFX5. The Dagger platform technology arms AlloCAR T cells with a CD70 CAR designed to recognize and deplete CD70-positive host immune cells while enabling tumor-targeting anti-CD19 AlloCAR T cells to resist rejection from the host immune cells. This endows the CAR-expressing T cells with dual specificity against tumors that co-express CD19 and CD70, which includes approximately 70% of patients with large B-cell lymphoma. As a result, this potential advance provides both a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells as well as insure against CD19 loss-mediated tumor escape, a known mechanism of resistance to CD19 CAR T therapy. The Dagger technology, a feature of our ALLO-316 candidate, has clinically demonstrated its unique immunomodulatory effect, contributing to robust AlloCAR T cell expansion and persistence even with relatively lower doses of CAR T cells and lymphodepletion than in other AlloCAR T programs. The ongoing Phase 1 dose escalation TRAVERSE study using investigational ALLO-316 in patients with advanced or metastatic renal cell carcinoma who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy.
XLO

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12:06 EDT Xilio reports initial monotherapy safety and anti-tumor activity data for XTX202 - Xilio Therapeutics announced initial safety, pharmacokinetic, pharmacodynamic and anti-tumor activity data from its ongoing Phase 1/2 clinical trial evaluating XTX202, an investigational tumor-activated, engineered, beta-gamma IL-2, in late line patients with advanced solid tumors. The data were presented at the Society for Immunotherapy of Cancer, or SITC, 38th Annual Meeting in San Diego, CA being held on November 1-5. "The newly reported data from our Phase 1/2 clinical trial for XTX202 expands the evidence across our programs supporting clinical validation of our tumor-activated technology. We observed a disease control rate of 50% at higher doses and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors. Importantly, treatment-related adverse events were primarily Grade 1-2 with no evidence of vascular leak syndrome reported at any dose level, and two patients are continuing on treatment for more than one year, highlighting XTX202's potential for long-term tolerability at high doses," said Katarina Luptakova, M.D., Chief Medical Officer of Xilio. "In addition, an analysis of an on-treatment biopsy from a patient receiving 2.8 mg/kg of XTX202 demonstrated evidence of activation in the tumor with minimal active drug in peripheral circulation and also suggests that monotherapy doses at or above 2.8 mg/kg are approaching the optimal range to engage CD8+ T effector cell and NK cell expansion while continuing to avoid stimulation of regulatory T cells. Overall, these encouraging data support continued evaluation of XTX202 at a dose of 4.0 mg/kg in our Phase 2 trial of patients with metastatic renal cell carcinoma and unresectable or metastatic melanoma and the exploration of opportunities for combination therapy."
MTAC

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12:04 EDT TriSalus Life presents data for SD-101 delivered by Infusion System - TriSalus Life Sciences announced initial positive safety and feasibility data from a Phase 1 trial at the Society of Immunotherapy for Cancer 2023 Annual Meeting. TriSalus is studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly using the Company's proprietary Pressure-Enabled Drug Delivery method of administration in three Phase 1 trials. In PERIO-03, SD-101 is delivered via PEDD with the TriSalus Infusion System using a retrograde venous approach, leveraging established interventional radiology access techniques. The TriSalus Infusion System has an expandable SmartValve and can interface with standard invasive blood pressure transducers for continuous pressure monitoring during infusion of a therapeutic. During infusion, the device blocks retrograde flow and modulates pressure in the vessel, resulting in the perfusion of the venous and capillary network isolated by the device. Early safety and feasibility data from the PERIO-03 locally advanced pancreatic adenocarcinoma trial revealed that in three patients who received SD-101 via retrograde venous infusion PEDD at the lowest dose level (0.5 mg), there were no serious grade 3/4 adverse events related to treatment. This is a first-in-human experience for use of PEDD and retrograde venous infusion for delivery of an immunologic agent into pancreatic tumors. Immune signals pointed to a decrease in myeloid derived suppressor cells activity in the treated pancreatic tumors, with declines in MDSC associated genes, including arginase-1, nitric oxide synthetase-2, and S100A9. Signals associated with T cell activation were also noted in pancreatic tumor biopsy specimens.
BCRX CLSD

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12:04 EDT Clearside to receive $5M upfront in license agreement with BioCryst - BioCryst Pharmaceuticals (BCRX) and Clearside Biomedical (CLSD) announced the entry into a license agreement enabling BioCryst to develop its investigational plasma kallikrein inhibitor, avoralstat, with Clearside's SCS Microinjector to deliver avoralstat directly to the back of the eye through the suprachoroidal space to treat patients with diabetic macular edema. Under the terms of the agreement, Clearside will receive a $5M upfront license fee from BioCryst. Clearside is eligible to receive up to an additional $30M in clinical and regulatory milestone payments, and up to a total of $47.5M in three post-approval sales-based milestone payments as annual global net sales progress to $2B. BioCryst will pay Clearside tiered mid-single digit royalties on annual global net product sales, at three tiers, including a top tier of greater than $1.5B.
MDNA

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12:03 EDT Medicenna Therapeutics presents preclinical data on MDNA113 - Medicenna Therapeutics announced new preclinical data demonstrating proof of concept for the company's novel T-MASK platform technology with the company's development candidate, MDNA113, at the 38th Annual Meeting of the Society for Immunotherapy of Cancer, or "SITC," held in San Diego, CA, from November 1-5. The company selected MDNA113, a novel, first-in-class tumor-targeted and tumor-activated bi-specific antiPD1-IL-2 Superkine as its first development candidate using the T-MASK platform. MDNA113 has high selectivity and affinity for the IL-13 decoy receptor IL-13Ralpha2, a tumor associated antigen expressed by many aggressive solid tumors. MDNA113 is fused via a protease sensitive linker to MDNA223, containing a not-alpha, beta-enhanced IL-2 Superkine fused to anti-PD1 antibody. "We are pleased to show preclinical data demonstrating the ability of our T-MASK platform to enhance tumor specific accumulation, increased anti-tumor activity while improving the safety profile of potent immune modulators such as Medicenna's bispecific IL-2-AntiPD1 Superkine," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "The results presented today demonstrates proof of concept with MDNA113, our first T-MASK candidate specifically designed to deliver bispecific IL-2-antiPD1 Superkine to cancers that express the tumor associate antigen, IL-13R2. This is an important advance for cancer immunotherapy as the IL13Ra2 target is linked to aggressive cancers that annually affect over 2 million patients world-wide."
XAIR

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12:02 EDT Beyond Cancer presents first-in-human clinical data for UNO therapy - Beyond Cancer, Ltd., an affiliate of Beyond Air announced first-in-human and first-in-class clinical data demonstrating a promising safety profile and clear evidence of immune system activation via biomarker response. The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of ultra-high concentration nitric oxide as an immunotherapeutic. These data were presented today at the Society for Immunotherapy of Cancer Annual Meeting 2023, which is being held in San Diego, California from November 1st to 5th via a poster presentation of abstract number 733. The Company's abstract presented at SITC includes safety, tolerability, biomarker and initial antitumor activity results from 5 subjects dosed with 25,000 ppm UNO. The data show UNO at 25,000 ppm delivered over 5-minutes upregulates cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells. Specifically, by Day 21, a single UNO administration resulted in an immunostimulatory effect. Dendritic cells increased more than 250%, representing more than a 2-fold increase in the magnitude observed in a murine model utilizing 50,000 ppm UNO. In addition, more than a 150% increase in T-central memory cells was observed, consistent with previously reported murine data. Encouragingly, there was also a greater than 50% increase in M1 macrophages over the same time period. UNO also had a favorable impact on the inhibitory cells of the immune system. T-regulatory cells decreased by 40% by Day 21 and myeloid derived suppressor cells decreased by greater than 30% by Day 7. Of the five heavily pre-treated patients treated as of this data cut, UNO was well tolerated with primarily Grade 1 related toxicities observed with an early clinical response in a highly refractory, salvage population.
LABD

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12:00 EDT Daily S&P Biotech Bear 3x Shares falls -16.1% - Daily S&P Biotech Bear 3x Shares is down -16.1%, or -$3.91 to $20.45.
AGL

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12:00 EDT Agilon Health falls -19.1% - Agilon Health is down -19.1%, or -$3.22 to $13.67.
BILL

Hot Stocks

12:00 EDT Bill falls -27.9% - Bill is down -27.9%, or -$24.93 to $64.54.
HIPO

Hot Stocks

12:00 EDT Hippo rises 24.6% - Hippo is up 24.6%, or $1.98 to $10.02.
PRLB

Hot Stocks

12:00 EDT Protolabs rises 25.8% - Protolabs is up 25.8%, or $6.26 to $30.56.
CPS

Hot Stocks

12:00 EDT Cooper-Standard rises 42.3% - Cooper-Standard is up 42.3%, or $5.38 to $18.11.
PODC LVO

Hot Stocks

11:59 EDT PodcastOne acquires exclusive rights to Vigilante podcast - PodcastOne (PODC), a podcast platform and a subsidiary of LiveOne (LVO), announced that it has acquired the exclusive sales and distribution rights, as well as certain ownership and IP and derivative rights, to a top true crime podcast, Vigilante. Named "Best True Crime Podcast of 2022" by Vulture and The Boston Globe, Vigilante debuted that same year. Season two of the hit podcast is set for Spring 2024. "For decades audiences around the globe have been fascinated with crime fighting citizens in film and television and now Vigilante tells the real life version of those stories and listeners are here for it," said Kit Gray, President and Co-Founder of PodcastOne.
MC

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11:56 EDT Moelis reaches settlement pact with SEC, will recognize $10M expense - In a regulatory filing, Moelis said it has reached an agreement on an Offer of Settlement with the U.S. Securities and Exchange Commission to resolve an administrative cease-and-desist proceeding regarding our practices relating to recordkeeping of business communications on messaging applications. Moelis & Company LLC agreed to be censured, pay a civil monetary penalty of $10M and comply with certain undertakings, including retaining a compliance consultant, related to retention of electronic communications as enumerated in the Settlement. As a result, the company recognized an expense of $10M for the nine months ended September 30, 2023, in other income and expenses in the condensed consolidated statements of operations.
AZN

Hot Stocks

11:36 EDT AstraZeneca: Zibotentan/dapagliflozin combination shows albuminuria reduction - Combination of zibotentan with dapagliflozin showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio, used to assess albuminuria, at 12 weeks compared with dapagliflozin alone. After 12 weeks of treatment, the Phase IIb ZENITH-CKD trial showed that the UACR difference of zibotentan/dapagliflozin versus dapagliflozin alone was -33.7% for high dose and -27.0% for low dose. The percentage mean change from baseline in UACR was -52.5% for high-dose and -47.7% for low-dose combination. These results were presented today at the American Society of Nephrology Kidney Week 2023 and simultaneously published in The Lancet. Previous studies showed endothelin A receptor antagonists are associated with high rates of fluid retention.2 The results from ZENITH-CKD showed low-dose zibotentan/dapagliflozin, but not high-dose, had comparable fluid retention events to dapagliflozin alone, with 18.4%, 8.8% and 7.9% of patients experiencing events in high-dose combination, low-dose combination and dapagliflozin groups, respectively. This novel investigational therapy leverages zibotentan, a highly selective ETA receptor antagonist that works by improving kidney blood flow and reducing albuminuria and vascular stiffness,10-13 and dapagliflozin, a selective sodium-glucose cotransporter 2 inhibitor proven to help delay the worsening of CKD in patients at risk of progression.14 Dapagliflozin works by driving fluid out of the extravascular space,15 potentially leading to a further reduction in the risk of fluid retention. These results support progress to Phase III, which aims to start in Q4 2023.
FLT

Hot Stocks

11:33 EDT Fleetcor does not intend to make offer for Equals Group - In a statement issued to the London Stock Exchange, Fleetcor said: "Fleetcor notes the announcement made by Equals Group on 1 November 2023 in response to market speculation. Fleetcor confirms that it has been contacted by Equals Group to assess whether it wishes to make an offer for the entire issued and to be issued share capital of Equals Group. Fleetcor announces that it does not intend to make such an offer for Equals Group. This is a statement to which Rule 2.8 of the Takeover Code applies. Fleetcor and any person(s) acting in concert with it reserves the right to make or participate in an offer for Equals Group (and/or take any other actions which would otherwise be restricted under Rule 2.8 of the Code) within the six months following the date of this announcement."
IEP

Hot Stocks

11:09 EDT Icahn Enterprises maintains quarterly distribution of $1.00 per unit - Icahn Enterprises declared a quarterly distribution in the amount of $1.00 per depositary unit, which will be paid on or about December 27, to depositary unitholders of record at the close of business on November 17. The distribution is unchanged from the prior quarter. As of September 30, Icahn Enterprises said its indicative net asset value increased $147M compared to June 30, and decreased $474M compared to December 31, 2022, respectively. Units of Icahn Enterprises are up 13% to $19.50 in morning trading.
AZ

Hot Stocks

11:04 EDT A2Z Smart Technologies appoints Dan Bechar as CTO of Cust2Mate - A2Z Smart Technologies announced the appointment of Dan Bechar as CTO of Cust2mate, A2Z's smart cart subsidiary and the issuance of U.S. Patent No. 11,715,082 titled "Shopping cart and system." With a diverse background that spans both corporate giants such as ECI Telecom and agile startups like Pointgrab and MantisVision, Dan brings a wealth of experience in large-scale operations. Additionally, A2Z announced the grant on August 1, 2023 of U.S. Patent No. 11,715,082, a significant milestone in our dedication to revolutionizing the retail experience through cutting-edge technology. Titled "Shopping cart and system," this patent underscores our ongoing efforts to create a smarter, more efficient, and frictionless shopping experience. Cust2Mate's patented technology enhances the convenience and efficiency of the shopping process, utilizing RFID scanners and computer vision to identify products, big data and machine learning to understand shopper preferences, and innovative features like a smart security scale and wellness tracking. The integrated retail media keeps shoppers informed and engaged, offering an unparalleled shopping experience. Further to A2Z's announcement from October 25, 2023, regarding Carrefour's connected cart project, A2Z would like to clarify that all purchase orders from Carrefour will be subject to a formal RFQ process, setting commercial terms, quantities and delivery dates.
GILD

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11:02 EDT Gilead to present late breaking data at The Liver Meeting 2023 - Gilead Sciences announced the presentation of new viral hepatitis data at the American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, from November 10-14. Key findings from more than 80 presentations will include a late-breaker oral presentation of primary endpoint results from the Phase 2b MYR204 study evaluating Hepcludex, an investigational therapy in the U.S. and outside of the European Economic Area, in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta virus, and an integrated analysis of Week 96 data from pivotal Phase 2b and Phase 3 studies evaluating the efficacy and safety of bulevirtide monotherapy. Gilead will also present long-term results from ongoing studies of Vemlidy in chronic hepatitis B, two-year efficacy, safety, and resistance data on TAF in pediatric patients with chronic HBV. In the U.S., Vemlidy is indicated for the treatment of chronic HBV in adults and pediatric patients 12 years of age and older with compensated liver disease. The use of Vemlidy for other patient populations is investigational, and the safety and efficacy for these uses have not been established. "We look forward to sharing our latest findings in the treatment of people living with HDV with the broader liver community at The Liver Meeting," said Anu Osinusi, Vice President Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences. "Despite meaningful advances in the treatment of people living with viral hepatitis, much work remains to improve diagnosis, care, and services to address the unmet needs of people living with viral hepatitis and pursue our continued commitment to help achieve HBV and HCV elimination goals by 2030."
TVTX

Hot Stocks

10:50 EDT Travere Therapeutics to present data from clinical studies of sparsentan - Travere Therapeutics announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy and focal segmental glomerulosclerosis. Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology Kidney Week 2023 and simultaneously published in The Lancet and The New England Journal of Medicine. Key Findings from the Two-Year PROTECT Study in IgAN: Treatment with FILSPARI resulted in one of the slowest rates of kidney function decline in an IgAN trial of its kind. The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan. This translates into a 3.7 mL/min/1.73m2 higher eGFR at two years with FILSPARI compared to irbesartan. This beneficial effect on preserving kidney function was durable post washout. Treatment effects on eGFR slope were consistent across baseline eGFR and proteinuria, supporting the potential for FILSPARI as a foundational treatment option across different stages of disease. When imbalances between treatment arms were factored into pre-specified eGFR analyses the beneficial effects of FILSPARI on kidney function preservation were strengthened. Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan. Treatment with FILSPARI resulted in the largest magnitude of sustained reduction in proteinuria shown in a pivotal trial over two years with FILSPARI-treated patients achieving a mean reduction in proteinuria from baseline of 43% compared to 4% for irbesartan-treated patients. More patients treated with FILSPARI achieved complete remission of proteinuria of less than 0.3 grams compared to those treated with irbesartan. FILSPARI was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the active control, irbesartan, including no drug-induced liver injury and no fluid overload. Key Findings from the Two-Year DUPLEX Study in FSGS: Treatment with sparsentan demonstrated a clinically meaningful and durable reduction in proteinuria, with FSGS patients achieving a 50% reduction from baseline, compared to a 32% reduction with the active control irbesartan. Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan. The combined hard endpoints of confirmed 50% reduction in eGFR, end-stage renal disease or death, trended in favor of sparsentan with fewer patients progressing to kidney failure. Sparsentan was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the active control, irbesartan, including no drug-induced liver injury and no fluid overload.
PGTI

Hot Stocks

10:46 EDT PGT Innovations establishes Triple Diamond Glass company - PGT Innovations announced the establishment of Triple Diamond Glass, a PGT Innovations company, marking a significant milestone in the organization's strategic growth. Triple Diamond Glass will offer innovative solutions to window and door manufacturers in the areas of energy efficiency, security, and sound abatement applications. The initial products to be produced include Tri-Ultra thin triple insulated glass units and Diamond Glass laminated glass units. The operations for Triple Diamond Glass will be housed in a facility strategically located in Prince George, Virginia, just south of Richmond. Triple Diamond Glass will initially focus on producing Tri-Ultra thin triple IGUs, which are in compliance with new energy efficiency values required to receive tax benefits under the Inflation Reduction Act and Energy Star Version 7 guidelines, as well as Diamond Glass, which offers passive protection for home security, noise reduction, and easier operation. These products are tailored for homeowners in North and North Central climate zones. Triple Diamond Glass will be the first and only manufacturer in the U.S. to offer easy, off-the-shelf, drop-in solutions with ultra-thin glass packages that fit current double-pane frame depths. The company's products will be available for window and door manufacturers to incorporate into their own existing products by the end of the first quarter of 2024. The 291,000-square-foot Triple Diamond Glass facility, located at 8800 Wells Station Road in Prince George, Virginia, was selected for its strategic placement close to the I-95 corridor and proximity to window and door manufacturers operating in northern climate zones. The region also boasts a highly skilled labor pool and an established manufacturing workforce, which will support the production and delivery of these high-quality products. Furthermore, the facility is equipped with cutting-edge technology, enhancing operational efficiency, and quality.
MARA

Hot Stocks

10:04 EDT Marathon Digital produces 1,202 bitcoin in October - "In October, we increased our energized hash rate 1% to 19.2 exahashes as the facility in Garden City, Texas, where we have 4.1 exahashes of miners installed, began to come online," said Fred Thiel, Marathon's chairman and CEO. "Once this facility is fully operational later this month, we will have surpassed our 23 exahash target and solidified Marathon as the largest publicly traded Bitcoin miner in North America. By increasing our hash rate and continuing to improve our operations at the facility in McCamey, Texas and elsewhere, we earned 4.0% of the total Bitcoin network's available miner rewards and produced 1,202 bitcoin in October. This total includes 18 bitcoin from our 20% share of the JV in Abu Dhabi. We now have 2.3 exahashes online in Abu Dhabi as our second, larger facility in Masdar City has begun powering up. We continue to expect the full 7.0 exahashes in the UAE to be online by year-end. We have also been exploring new methods of mining that we believe may allow us to further diversify our operations, reduce our energy costs, and increase our sustainable energy mix. We recently announced a pilot project in Utah that is exclusively powered by landfill methane gas. Naturally produced methane is often stranded, and Bitcoin miners like Marathon are uniquely positioned to help capture and convert this environmentally harmful gas into clean, renewable energy. We look forward to sharing more of the many innovative mining projects that we are exploring in the months ahead."
HLIO

Hot Stocks

10:00 EDT Helios Technologies falls -14.6% - Helios Technologies is down -14.6%, or -$7.70 to $45.12.
AGL

Hot Stocks

10:00 EDT Agilon Health falls -17.8% - Agilon Health is down -17.8%, or -$3.00 to $13.89.
BILL

Hot Stocks

10:00 EDT Bill falls -32.8% - Bill is down -32.8%, or -$29.39 to $60.08.
HIPO

Hot Stocks

10:00 EDT Hippo rises 29.7% - Hippo is up 29.7%, or $2.39 to $10.43.
CPS

Hot Stocks

10:00 EDT Cooper-Standard rises 37.2% - Cooper-Standard is up 37.2%, or $4.73 to $17.46.
CANO

Hot Stocks

10:00 EDT Cano Health rises 9087.5% - Cano Health is up 9087.5%, or $10.18 to $10.29.
HLIO

Hot Stocks

09:47 EDT Helios Technologies falls -10.6% - Helios Technologies is down -10.6%, or -$5.62 to $47.20.
AGL

Hot Stocks

09:47 EDT Agilon Health falls -11.2% - Agilon Health is down -11.2%, or -$1.89 to $15.00.
BILL

Hot Stocks

09:47 EDT Bill falls -28.0% - Bill is down -28.0%, or -$25.01 to $64.46.
FIGS

Hot Stocks

09:47 EDT Figs rises 23.1% - Figs is up 23.1%, or $1.30 to $6.92.
CPS

Hot Stocks

09:47 EDT Cooper-Standard rises 27.1% - Cooper-Standard is up 27.1%, or $3.45 to $16.18.
CANO

Hot Stocks

09:47 EDT Cano Health rises 9033.9% - Cano Health is up 9033.9%, or $10.12 to $10.23.
DH

Hot Stocks

09:40 EDT Definitive Healthcare trading resumes
IOAC

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09:38 EDT Innovative International Aqstn Corp trading resumes
IOAC

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09:33 EDT Innovative International Aqstn Corp trading halted, volatility trading pause
DH

Hot Stocks

09:30 EDT Definitive Healthcare trading halted, volatility trading pause
FQVLF

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09:25 EDT First Quantum Minerals provides update on Panama - First Quantum Minerals notes that during the week commencing October 30, 2023, the National Assembly of Panama held ordinary and extraordinary sessions concerning Bill 1109 and Bill 1110. Bill 1109 relates to the initially proposed popular consultation regarding Law 406. Law 406, enacted on October 20, 2023 by the National Assembly of Panama, approved the revised contract for the Cobre Panama mine agreed between the Company's Panamanian subsidiary, Minera Panama S.A, and the Government of Panama. Bill 1110 originally proposed a moratorium on the granting of new concession contracts related to mining in Panama. With respect to Bill 1109, following the first of three required debates that took place during the final ordinary session of the National Assembly on October 31, 2023, no further debates took place during the extraordinary sessions on November 2 and 3, 2023. It is the Company's understanding that no further debates of Bill 1109 are currently scheduled. Bill 1110 progressed through two debates of the National Assembly, during which an amendment was made to the bill proposing the repeal of Law 406. During the third debate concerning Bill 1110 on November 2, 2023, the National Assembly resolved to send the bill back to the second debate and removed the amendment proposing the repeal of Law 406. An extraordinary session has been called for November 3, 2023. The Company notes that a number of lawsuits challenging the constitutionality of Law 406 have been submitted to the Supreme Court of Justice, of which at least four have been admitted. First Quantum continues to monitor the situation and is confident with respect to its legal position and that of MPSA, in respect of all matters and developments referenced herein and reserves all of its and MPSA's rights in Panama and internationally. Production at the Cobre Panama mine remains uninterrupted at this time, however, like many businesses across Panama, protests, including blockades of key roads, have caused disruptions on site as well as shortages in certain supplies. First Quantum is proud of its contribution to Panama. The Cobre Panama mine plays an important role in Panama's economic development. Approximately 90% of the workforce at Cobre Panama is Panamanian and it is estimated that approximately 1 in 50 people from Panama's working population is employed, directly or indirectly, by the mine1. With Cobre Panama, the country will play a key role in the green energy transition by delivering the copper required for renewable power and electric vehicles. The copper produced by Cobre Panama in 2022 would be enough for more than 6 million electric cars2. First Quantum is a responsible miner and takes its obligations in this regard very seriously. The Company respects its legal obligations, both local and international, and conforms to high standards of ethical behavior in its business conduct. The Company is also committed to the principles of integrity and transparency in its dealings with governments around the world. The Government of Panama approved MPSA's comprehensive Environmental and Social Impact Assessment comprising of over 14,000 pages and which serves as the foundation for close to 400 ongoing commitments. The Company's ESIA compliance is subject to regular audits by the government, as well as independent third parties, and is managed by a dedicated team of more than 200 people. The Company's current solid liquidity position remains consistent with the $2.3 billion at the end of the third quarter, with first senior notes not due until April 2025.
FMCC

Hot Stocks

09:23 EDT Freddie Mac announces tender offer for any, all of certain STACR notes - Freddie Mac announced that it has commenced a fixed-price cash tender offer for the purchase of any and all of the STACR Notes listed in beginning Friday, November 3, 2023. Certain of the classes of Notes subject to the Offer were issued by the STACR Trust identified in the table below. Freddie Mac is the holder of the owner certificate issued by each Trust and, as a result, the sole beneficial owner of each Trust. Freddie Mac has engaged Wells Fargo Securities, LLC and BofA Securities, Inc. as lead dealer managers and Academy Securities, Inc. as co-dealer manager for the Offer. Freddie Mac is offering to purchase any and all of the Notes listed. The applicable Total Consideration to be paid by Freddie Mac to holders that tender Notes accepted for purchase pursuant to the Offer will be calculated based on the original principal amount of such tendered and accepted Notes, the applicable factor, and the applicable Tender Offer Consideration identified in the table below, plus any accrued and unpaid interest under the applicable Debt Agreement or Indenture upon the terms and subject to the conditions set forth in the Offer to Purchase dated November 3, 2023 and related Notice of Guaranteed Delivery dated November 3, 2023. Capitalized terms used and not otherwise defined herein will have the meaning ascribed to such terms in the Offer to Purchase. The tender offer period will commence on Friday, November 3, 2023, and expire at 5 p.m. New York City time on Thursday, November 9, 2023, unless extended. Holders must validly tender their Notes at or prior to the Expiration Time. Notes validly tendered may be withdrawn at any time at or prior to 5 p.m., New York City time, on Thursday, November 9, 2023, unless extended by Freddie Mac, but not thereafter.
CZR

Hot Stocks

09:22 EDT Caesars Sportsbook launches in Maine - Sports wagering is live in Maine, and Caesars Entertainment announced that its flagship sports wagering platform, Caesars Sportsbook, is accepting sports wagers on mobile and desktop in the Pine Tree State. Caesars Sportsbook launches through Caesars' historic partnership with three of the Wabanaki Nations: the Houlton Band of Maliseet Indians, the Mi'kmaq Nation and the Penobscot Nation, furthering Caesars Entertainment's longtime commitment to supporting Indian gaming.
THER

Hot Stocks

09:21 EDT Theralink announces results on proteomic analysis in Molecular Tumor Board - Theralink Technologies announced that their long-standing, strategic partnership with the Inova Schar Cancer Institute is beginning to deliver promising results by way of assessing the feasibility and impact of the actionable information provided by the Theralink assay into Inova's Molecular Tumor Board-based treatment decisioning making for cancer patients. The partnership involves the integration of the Theralink assay, protected by ten patents, into Inova's molecular tumor board's operational workflow. Over the past year, Inova has undertaken a feasibility study to develop and implement the procedures and infrastructure necessary for proteomic analysis within the context of the Inova Schar Molecular Tumor Board. The Theralink assay provides a direct means of determining the actionability of genomic derangements identified, as well as directly measuring the activation/elevation of protein drug targets otherwise missed by genomic analysis alone. Thus, the incorporation of key phosphoprotein and protein data generated by Theralink's RPPA technology into the Inova MTB could synergize with current genomics analysis to produce more accurate treatment selection and patient-tailored therapy regimes. Interim results of this pan-tumor study were presented at the 2023 ASCO Conference in Chicago. Specifically, the analysis examined the feasibility of incorporating laser capture microdissection enrichment of tumor specimens and reverse phase protein array analysis with next generation sequencing into a molecular tumor board for improving selection of targeted cancer therapy. Integrated review of the RPPA and NGS data by the MTB supported a clinical recommendation change for over half of the patients overall. Further, the proteomics data from the Theralink assay provided additional treatment considerations for 59% of the patients, the outcomes for whom continue to be monitored. Moreover, the collaboration with Inova and their MTB resulted in a recent finding1 wherein the Theralink proteomics data revealed a specific mechanism of resistance and likely lack of benefit to a targeted therapy being considered by the MTB for a patient with a rare form of inflammatory myofibroblastic cancer. Lastly, Inova and Theralink presented the results of another important study at ASCO 2023 that focused on Theralink's unique ability to quantitatively measure HER2 abundance and activation and found that nearly 50% of pancreatic tumor actually express moderate amounts of HER2 protein, which could be missed by existing commercial HER2 assays. While HER2 expression is not routinely evaluated in clinical practice for pancreatic cancer these results may have clinical implications, especially as new classes of HER2 antibody drug conjugates are considered for patients with HER2 non amplified tumors across organ sites. Theralink and Inova will update findings and results post study completion. Published results are anticipated in early 2024.
CRON

Hot Stocks

09:18 EDT Lord Jones launches Hash Fusions pre-rolls in Canada - Cronos Group announced that it has launched its cannabis brand Lord Jones in the Canadian adult-use cannabis market. The first Lord Jones product to launch in Canada are Lord Jones Hash Fusions pre-rolls. The popularity of hash products and premium pre-rolls is increasing amongst adult consumers. Hash is currently the most popular solventless infusion and is the second most popular infusion overall in the pre-roll category. The Lord Jones Hash Fusions pre-rolls go beyond delivering an elevated, true-to-plant consumption experience. These pre-rolls are crafted with an optimized ratio of premium high-potency flower and complementary solventless ice water hash, which preserves the buds' natural terpenes, fitted with a reusable ceramic tip to help cool the smoke. This new product has been extensively researched and sensory tested to deliver a smoother experience featuring bold cannabis flavors.
SLNH

Hot Stocks

09:16 EDT Soluna Holdings regained compliance with Nasdaq minimum bid price requirement - On October 31, Soluna Holdings announced that on October 30 it had received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market notifying the company that it had regained compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rule 5550.
SLNH

Hot Stocks

09:15 EDT Correction: Soluna regained compliance with Nasdaq bid price requirement - A prior headline stating that Soluna Holdings received a noncompliance notification from Nasdaq has been removed.
AMCX

Hot Stocks

09:14 EDT AMC Networks has 'robust slate of content' heading into 2024 - Says no impact to free cash flow or AOI from SAG-AFTRA strike. Feels "quite good" about ability to grow free cash flow in 2024. Says managing the business for free cash flow vs. AOI.
MWA

Hot Stocks

09:06 EDT Mueller Water sees FY23 revenue $1.26B-$1.275B, consensus $1.25B - Mueller Water Products announced selected preliminary financial information for its fourth quarter and fiscal year ended September 30, 2023, and updated timing for reporting results for fiscal 2023. Adjusted EBITDA is expected to be between $197 million and $203 million. "For fiscal 2023, our preliminary consolidated net sales and adjusted EBITDA exceeded the expectations we provided with our third quarter 2023 results. We ended fiscal 2023 with a strong balance sheet and liquidity, allowing us to continue reinvesting in our operations while returning cash to shareholders through our quarterly dividend, which was recently increased for the eighth time since 2014, as well as through share repurchases," said Martie Edmunds Zakas, Chief Executive Officer of Mueller Water Products.
CTG

Hot Stocks

09:05 EDT CTG, Cegeka extend tender offer for outstanding CTG shares - Cegeka Groep and Computer Task Group announced that Chicago Merger Sub, a wholly owned subsidiary of Cegeka, has extended the expiration date of its offer to acquire all of the outstanding shares of common stock of CTG, par value $0.01 per share, for $10.50 per Share, net to the seller in cash, without interest and less any applicable withholding taxes, pursuant to the Agreement and Plan of Merger, dated as of August 9, 2023, by and among Cegeka, CTG, and Merger Sub, The Offer, which is scheduled to expire at one minute after 11:59 P.M., Eastern Time, on November 3, 2023, has been extended until one minute after 11:59 P.M., Eastern Time, on December 12, 2023, unless the Offer is further extended or earlier terminated pursuant to the terms of the Merger Agreement.
TCLAF

Hot Stocks

09:03 EDT Transcontinental announces expansion of raddar - TC Transcontinental announces the expansion of raddar, the reinvented flyer, across Quebec as well as in areas of Ontario and British Columbia. raddar is a thin leaflet folded in four that combines flyers from various retailers into a single printed product. "We are proud of raddar, a landmark innovation in the history of flyers, and the significant environmental gain it represents," said Patrick Brayley, Senior Vice President, TC Transcontinental Printing. "At the same time, we regret the impact of the end of Publisac on several weekly newspapers as well as on our distribution partners. Given recent and expected regulatory changes for distribution and their operational and financial impacts, the Publisac model had to evolve."
AVGO NFLX

Hot Stocks

09:03 EDT Broadcom says German court's preliminary opinion finds patent valid - Broadcom (AVGO) announced that the German Federal Patent Court issued a preliminary opinion finding that a Broadcom patent related to HEVC/H.265 video coding is valid. This opinion follows a September 19, 2023 judgment by the District Court of Munich that Netflix (NFLX) infringes this patent. The Munich Court also issued an injunction requiring Netflix to cease and desist all further infringement in Germany. The European patent at issue, EP 2 575 366, covers key features of digital video processing often used in HEVC video coding. The Munich District Court ruled that Netflix infringes the '366 Patent through its transmission of HEVC video, which Netflix uses to provide Ultra HD content to its users. Broadcom has filed a motion with the Munich Court seeking penalties for Netflix's lack of compliance with the injunction. Under section 890 of the German Civil Procedure Code, penalties for violating the injunction include: government fines of up to EUR 250,000 for each act of infringement, such as each time Netflix sends an infringing video stream to a German subscriber; and/or up to six month's imprisonment for members of the infringer's board of directors. Since 2018, Netflix and Broadcom have been engaged in a wide-ranging patent dispute in which Broadcom has accused Netflix of infringing numerous U.S., German, and Dutch patents through its provision of its video streaming service. The German Federal Patent Court will make its final decision on Netflix's invalidity lawsuit after the oral hearing, scheduled for July 18, 2024.
BVN

Hot Stocks

09:03 EDT Buenaventura to sell Contacto Corredores De Seguros for $33.7M in cash - Buenaventura announced that it has reached a definitive agreement to sell 100% of Contacto Corredores De Seguros, the company's risk and insurance brokerage, to Howden Holdco Peru S.A.C., a subsidiary of Howden Broking Group, for $33.7M in cash, as well as an additional variable cost with an approximate cap of US$ 1.6 million dollars subject to closing certain conditions.
BIRD

Hot Stocks

09:02 EDT Allbirds announces debut of Wool Runner 2 - Allbirds is announcing the debut of the Wool Runner 2. "The Wool Runner 2 is a dramatically improved product experience. We focused our innovation engine on harnessing some of the world's most sustainable materials, alongside the many lessons we've gained over the last seven years," said Joey Zwillinger, co-founder and CEO, Allbirds. "We're retaining the understated design of the iconic Wool Runner, while offering a modern aesthetic to meet the needs of today's customers, coupled with dramatically increased durability and comfort."
SNDA

Hot Stocks

09:01 EDT Sonida Senior Living appoints Tabitha Obenour as chief clinical officer - Sonida Senior Living announced the appointment of Tabitha Obenour as VP and chief clinical officer, effective November 1. Obenour joins Sonida from senior living provider Enlivant where she served as the company's VP of clinical quality and compliance. Prior to Enlivant, Obenour spent nine years at Genesis Healthcare, one of the nation's largest providers of post-acute care with skilled nursing centers and senior living communities in 34 states. She started as director of nursing prior to becoming the company's leader of clinical operations, overseeing clinical operations for 21 skilled nursing centers.
FNV

Hot Stocks

08:59 EDT Franco-Nevada's partner First Quantum Minerals issues update - Franco-Nevada notes that its partner, First Quantum Minerals, has issued an update regarding the various Government of Panama bills and unconstitutionality challenges in respect of Law 406, the law that approved the revised concession contract for the Cobre Panama mine. First Quantum has also advised that production at the mine remains uninterrupted at this time, while protests have caused disruptions on site as well as shortages in certain supplies.
EPOW

Hot Stocks

08:57 EDT Sunrise New Energy completes construction of Zone B at Guizhou plant - Sunrise New Energy announced the completion of construction in Zone B of its plant in Guizhou. Zone B covers an area of 128,000 square meters, with the factory facilities occupying 20,400 square meters and the office covering 1,800 square meters. The main facilities in Zone B include the rolling and grinding workshops, as well as the finished goods warehouse. Previously, the Company had completed Zone A, which is primarily used for graphitization, crushing and granulation, including workshops 1 and 8, a laboratory, and an office building. The construction of Zone B provides an important expansion to the company's production capabilities. To further reinforce its commitment to transparency and openness, Sunrise has installed 11 cameras at different angles in both Zone A and Zone B of its plant. These cameras provide a 24/7 live stream of the factory's operations, allowing investors and customers to observe the ongoing work and the products being manufactured. The Company believes that it is the first public company in the world to offer a real-time 24/7 live stream of its product manufacturing processes.
AMCX

Hot Stocks

08:48 EDT AMC Networks says 'making great strides' in advertising - Says scatter and direct advertising markets "remain challenging." Says 'laser focused' on managing the business responsibly. Says "nicely set up" to achieve free cash flow objectives for 2023.
ARRY

Hot Stocks

08:46 EDT Array Technologies launches Field Services and Customer Training solutions - Array Technologies announced the launch of its comprehensive Field Services and Customer Training solutions. Designed to meet the ever-evolving demands of the solar industry, these offerings tackle key challenges facing the industry to help reduce operational downtime and increase productivity and quality in the field. The on-site and remote services and training offerings, currently available in the U.S. with plans to expand to international markets in the future, are crafted to meet the unique needs of engineering, procurement and construction professionals, utility-scale solar, operation and maintenance partners, and solar site developers.
ALLG

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08:42 EDT Allego signs two PPAs with Energy Solutions Group - Allego announced that it has signed two power purchase agreements, or PPAs, totaling 100 gigawatt hours, or GWh, of energy per year with Energy Solutions Group, the largest independent green energy producer in the Benelux region. The application of these PPAs is expected to enable Allego to stabilize its input cost base and minimize the impact of commodity price volatility on its operational and margin profile while sourcing renewable solar and wind energy. PPAs are also another way to reinforce Allego's efforts in its mission to provide 100% renewable energy to its growing EV charging network. As it seeks to achieve this goal, Allego has developed an entire ecosystem within the organization to procure, monitor, and distribute clean energy to its network, including its demand and supply optimization software, making it a pure-play charge point operator that is also an energy provider. This framework permits Allego to have more control over the energy it receives and delivers to its network, ultimately providing a better user experience for the EV driver.
TNON

Hot Stocks

08:39 EDT Tenon Medical passes FDA QSIT Level 2 Inspection - Tenon Medical announced the US Food and Drug Administration concluded a full Quality System Inspection Technique Level 2 Inspection at Tenon Medical. The QSIT inspection, used to assess a medical device manufacturer's compliance with the Quality System Requirements and related regulations, guides the FDA investigators in performing an efficient and effective inspection, focusing on all key elements of a firm's Quality Management System. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts. Observations are made when in the investigator's judgement, conditions or practices observed would indicate that the device has been adulterated or is being prepared, packed, or held under conditions whereby it may be come adulterated or rendered injurious to health. At the conclusion of the inspection on November 1, 2023, the FDA investigator determined there was no need to issue Form 483 and the Closing Meeting was completed with no observations or objectionable conditions identified. A final report will be issued to the Company over the coming weeks.
HNRA

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08:38 EDT HNR Acquisition adjourns Special Meeting to approve business combination - HNR Acquisition Corp filed a definitive proxy statement with respect to a special meeting of its stockholders to be held on Monday, October 30, 2023 at 1:30 p.m. eastern to vote on, among other things, a proposal to adopt and approve that certain Amended and Restated Membership Interest Purchase Agreement dated August 28, 2023, and the transactions contemplated thereby. The Company opened the Special Meeting and only considered the proposal for adjournment. The Special Meeting was then adjourned. The Company has determined to reconvene the Special Meeting via a live web cast on Monday, November 13, 2023 at 10:00 a.m. eastern. Only holders of record of shares of the SPAC Company's common stock at the close of business on October 10, 2023, are entitled to vote. Based upon the preliminary reports that have been provided to HNRA, the holders of an aggregate of 4,480,725 public shares of HNRA's common stock have submitted requests that their public shares be redeemed in connection with the Special Meeting, with these redemptions only taking effect upon the closing of the Business Combination. Shareholders will have the right to exercise their right to redemption until 5:00 p.m. eastern on November 9, 2023.
JFBR

Hot Stocks

08:38 EDT Jeffs' Brands starts sales of its new line targeting bedbug outbreak in France - Jeffs' Brands announced that its brand of pest control solutions sold under the Fort Brand has launched its new product line targeting bedbug pest control on the Amazon Marketplace in France. "Our dedication lies in delivering efficient products that align with current market demands. Our latest product line addresses a growing issue in our recently established market, France. We intend to persistently introduce new Fort Brand products and extend our presence to a broader customer base in key regions," said Viki Hakmon, Chief Executive Officer of Jeffs' Brands.
BCTX

Hot Stocks

08:37 EDT BriaCell reports unprecedented activity of its next-gen cancer immunotherapies - BriaCell reports unprecedented activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies at the 2023 Society for Immunotherapy of Cancer, SITC, annual meeting. These novel immunotherapies have been shown to activate the immune system through multiple mechanisms including adaptive responses of naive T cells and innate responses of dendritic cells and natural killer cells leading to enhanced clinical efficacy and prevention of immune escape. BriaCell's current lead candidate, Bria-IMT, has enhanced efficacy in human leucocyte matched patients and led to the development of Bria-OTS, an off the shelf personalized immunotherapy providing HAL matched targeting to greater than99% of the US population. "We are extremely excited with our findings confirming unprecedented immune system responses to our novel next generation breast and prostate cancer immunotherapies - designed with additional immune activating components for superior efficacy," stated Dr. William V. Williams, BriaCell's President & CEO. "We expect our novel immunotherapies to boost the immune system in cancer patients leading to tumor destruction. We believe that our technology represents a significant advancement in the field of oncology and personalized immunotherapy."
AGNMF

Hot Stocks

08:36 EDT Agronomics calculates NAV at 16.48p per share as of September 30 - Agronomics Limited announces that its unaudited Net Asset Valuation per share calculation as at closing on 30 September 2023 was 16.48 pence per share, a 4% increase from 15.80 pence per share on 30 June 2023. Net Assets were GBP 164 million, including investments of GBP 140 million and uninvested cash and short-term deposits of GBP 24 million. The share price of 9.80 pence at the 30 September 2023 close represented a discount of 40% to the 30 September 2023 NAV per share. The average discount to the prevailing NAV per share over the last 12-month period was 39%. Under IFRS, the Company's unquoted investments are generally carried at cost or the most recent priced funding round.
CHRS

Hot Stocks

08:35 EDT Coherus Biosciences presents data from next-generation immuno-oncology programs - Coherus BioSciences announced data from three immuno-oncology pipeline programs at the 38th Annual Meeting of SITC taking place November 1 - 5, 2023 at the San Diego Convention Center in San Diego, CA. Preclinical data presented support differentiated mechanisms of its next-generation immunotherapies potentially enabling the antitumor immune activation in more cancer patients and enhanced treatment outcomes. "These data presented at SITC highlight the complementary mechanisms that we have in our innovative immunotherapy portfolio, including anti-PD-1, anti-IL27 and anti-CCR8, and the promise of novel immuno-oncology treatment combinations that may overcome the challenging tumor microenvironment," said Theresa LaVallee, Ph.D., Coherus' chief development officer. "LOQTORZI(TM) is the first approved treatment option for patients with nasopharyngeal carcinoma, and we will continue to generate and use data to optimize our clinical development plans through the selection of additional tumor types and immuno-oncology combinations that can have the greatest impact on extending survival for cancer patients."
BBU

Hot Stocks

08:34 EDT Brookfield Business receives regulatory approval for sale of Westinghouse - Brookfield Asset Management announced the receipt of all required regulatory approvals to close the previously announced sale of Westinghouse Electric Company to a consortium of Cameco Corporation and Brookfield Renewable Partners. The transaction is expected to be completed on or about November 7, 2023.
WISH

Hot Stocks

08:34 EDT ContextLogic releases inaugural 'Anti-Counterfeiting Report' - ContextLogic announced the release of its inaugural 'Anti-Counterfeiting Report'. The publication of the report represents a significant step in Wish's ongoing commitment to combating the listing and sale of counterfeit goods on its platform. Wish's first 'Anti-Counterfeiting Report' provides an overview of the tools and resources it has in place to detect and enforce against the listing or sale of allegedly counterfeit goods. The report also shines a light on some of the progress Wish has made over the past 6 months to clamp down on counterfeiters, which includes: Processing more than 9,000 IP violations that were reported via the 'Report this Listing' button, email, online web form or Wish's Brand Partner Program Portal; Responding to 98% of all IP violation takedown requests within 24 hours, further demonstrating Wish's commitment to promptly addressing and resolving IP or counterfeit concerns; Issuing over 700,000 infractions to violating merchants, ranging from impression blocking to store suspension; Signing up more than 2,300 brands to Wish's Brand Partner Program since its inception in 2016.
RWAY

Hot Stocks

08:33 EDT Runway Growth Finance board declares supplemental dividend of 6c per share - Runway Growth Finance announced that its Board of Directors has declared a fourth quarter 2023 cash distribution of 40c per share. In addition, the Board of Directors declared a supplemental dividend of 6c per share, for the fourth quarter of 2023.
WKHS

Hot Stocks

08:32 EDT Workhorse Group reschedules Q3 earnings call - Workhorse Group announced that, in light of a scheduling issue, it has rescheduled its third quarter earnings conference call to Tuesday, November 14th at 8:00 a.m. Eastern time. Workhorse will discuss financial results for the third quarter ended September 30, 2023 as well as the Company's plans and outlook. Financial results will also be issued in a press release prior to the call.
STLD

Hot Stocks

08:31 EDT Steel Dynamics approves $1.5B additional share repurchase program - Steel Dynamics announced that the company's board of directors authorized an additional share repurchase program of $1.5B of the company's common stock. The authorization is effective immediately and is additive to the previous $1.5B program, which had $278M remaining authorized and available for repurchase on September 30. Since 2017, the company has repurchased $5.2B of its common stock, representing 36 percent of its outstanding shares, and has paid cash dividends of $1.4B through September 30.
WLDS

Hot Stocks

08:21 EDT Wearable Devices receives purchase order from industrial automation company - Wearable Devices announced the receipt of a purchase order for its evaluation kit samples and dedicated evaluation software from a prominent Japanese industrial automation company. This automation company, which is renowned for enhancing worldwide manufacturing productivity and efficiency through its cutting-edge sensing and control technology, is set to usher in a transformative phase for robot control applications using Wearable Devices' pioneering technology.
XVIPF

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08:18 EDT Xvivo Perfusion announces publication from study using heart technology - XVIVO Perfusion announced the results of the clinical trial conducted in Australia and New Zealand on XVIVO's heart technology were earlier this week published in the prestigious scientific journal, The Journal of Heart and Lung Transplantation. The study concludes that donor hearts that were previously considered unsuitable for transplantation due to long distances between hospitals may be transplanted with a 100% survival rate at 30-days when transported in XVIVO Heart Assist Transport. Ice-based, cold static storage, is still used during transport of the vast majority of donor hearts. When the transport time of the heart exceeds 4 hours, the transplanted patient faces an increased risk of severe complications or even death. This risk increases significantly with each additional hour of transport. Still, up to 40% of transplant recipients are exposed to this risk due to the scarcity of donor hearts. The long distances between hospitals will often prevent the use of a donor heart at all, leaving a critically ill person waiting for a new organ. In the study conducted at five transplant centers across Australia and New Zealand, researchers investigated the use of donor hearts with a projected transport time of 6-8 hours using the XVIVO Heart Assist Transport device. The 36 included patients received donor hearts with a mean transport time of nearly 7 hours, with the longest transport time being 8 hours and 47 minutes. Survival at 30 days after transplant was 100%, with only one patient developing primary graft dysfunction, which resolved within a week.
TRV

Hot Stocks

08:14 EDT Travelers to acquire Corvus Insurance for $435M - Travelers announced that it has agreed to acquire Corvus Insurance for approximately $435M. Founded in 2017, Corvus is a cyber insurance managing general underwriter, powered by proprietary technology. Powered by a proprietary, AI-driven cyber risk platform, Corvus has developed a suite of integrated cyber sales, service and support capabilities. The Corvus team has expertise in the cyber product line and a presence in the middle-market excess and surplus cyber insurance marketplace, serving both wholesale brokers and large retail producers. Through its platform, Corvus effectively identifies vulnerabilities throughout the policy period to reduce customers' exposure to cyber events. Corvus' platform also delivers distribution efficiencies to insurance agents and brokers. Driven by its proven technology and dynamic team, Corvus has grown its business at attractive loss ratios. Travelers will fund the transaction from internal resources. The transaction is expected to close in the first quarter of 2024, subject to regulatory approvals and other customary closing conditions. While the acquisition is strategically important, the expected impact to earnings in the near term is immaterial.
MTEK

Hot Stocks

08:14 EDT Maris-Tech receives grant approval of $156K from IAA - Maris-Tech has a grant approval of approximately $156,000 from the Israel Innovation Authority to support the second year of a joint development project with the Ben Gurion University of the Negev. The grant represents 66% of the total budget for the second year operation of the ongoing joint project to develop an advanced system based on AI and machine learning for diagnosing and predicting drone faults and malfunctions. The total budget for the two-year project is approximately $695,000. The aim of the project is to adapt and integrate an identification and prediction model developed at BGU in existing Maris-Tech systems. The grant was approved based on the successful completion and meeting of the objectives of the first-year work plan and the continued successful collaboration between Maris-Tech and BGU.
ARDX

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08:13 EDT Ardelyx shares data from studies of XPHOZAH at ASN Kidney Week 2023 - Ardelyx shared positive data on the use of XPHOZAH in poster presentations at the American Society of Nephrology, ASN, Kidney Week 2023 meeting, currently being held in Philadelphia, Pennsylvania, and will showcase XPHOZAH in an Exhibitor Spotlight event. Ardelyx's presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease. The first poster, titled Optimal Initiation of Tenapanor Treatment Analyzed by Baseline Phosphate Binder Dose: A Sub-analysis of the OPTIMIZE Study, looked at serum phosphate control across two cohorts of patients by phosphate lowering pill burden. The OPTIMIZE study showed that both cohorts experienced improved sP control and improved patient reported quality of life, as well as a reduction in pill burden. In a poster titled Patient Education Improves Adherence to Tenapanor Treatment in OPTIMIZE Study, researchers looked at the effect of patient education on adherence, using data from the OPTIMIZE study compared to data from two phase 3 clinical studies of tenapanor, BLOCK and PHREEDOM. The study found that this educational information improved adherence, and may have specifically reduced medication discontinuation due to changes in bowel habits. The third poster, Safety Analysis of Tenapanor Monotherapy vs Sevelamer Carbonate in Patients on Maintenance Dialysis with Hyperphosphatemia, reviewed patient data from the PHREEDOM study that evaluated tenapanor for the treatment of hyperphosphatemia in patients with CKD on maintenance dialysis. The study showed that a lower proportion of patients treated with tenapanor versus sevelamer experienced a serious adverse event while the exposure adjusted rates were similar. This analysis also showed that the incidence of adverse events leading to hospitalization was lower in the tenapanor arm than the sevelamer arm while the exposure adjusted rates were similar. The final Ardelyx poster to be shared at ASN, Tenapanor in Combination with Phosphate Binders Improves Short and Long-Term Control of Serum Phosphate in Patients on Dialysis with Hyperphosphatemia.
FLL

Hot Stocks

08:12 EDT Full House Resorts announces open reservations for Chamonix Casino Hotel - Chamonix Casino Hotel announced that hotel reservations for Colorado's newest casino destination are now open. The 300-room hotel will feature the first luxury guest rooms in the Cripple Creek market, skillfully blending the comfort and charm of Colorado with European elegance. Both the casino and hotel are scheduled to open to the public on December 26, 2023. Located adjacent to our existing Bronco Billy's Casino, Chamonix will feature a spacious, new, stylish and exciting casino gaming area; a fine-dining restaurant operated by Barry Dakake, a celebrated chef known for leading several steakhouses in Las Vegas; a rooftop pool and high-end spa; entertainment and meeting space, including a 5,100-square-foot ballroom; and approximately 300 luxurious guest rooms and VIP suites. Fireplaces, soaking tubs, and balconies with spectacular views of The Rockies are just some of the highlights awaiting discovery in many of Chamonix's guest rooms.
CVRX

Hot Stocks

08:11 EDT CVRx increases outpatient payment for Barostim procedure - CVRx announced that Centers for Medicare and Medicaid Services, CMS, has reassigned the Barostim implant procedure for procedures performed in the outpatient setting as part of the 2024 Medicare Hospital Outpatient Prospective Payment System, OPPS, final rule. In the 2024 OPPS final rule, Barostim was reassigned to New Technology APC 1580, which carries an average payment amount of $45,000. The new payment takes effect January 1, 2024. In 2023, Barostim was assigned to APC 5465, which carries an average payment amount of $29,000, with a Transitional Pass-Through Payment set to expire on December 31, 2023. "We sincerely appreciate the consideration taken by CMS of the resource requirements associated with the Barostim implant procedure. We believe that reassignment to APC 1580 will facilitate increased access to the therapy for Medicare patients with heart failure by offering facilities sufficient reimbursement for the procedure," said Nadim Yared, President and CEO of CVRx. "We are grateful for the support of the cardiology physician community in sharing their positive Barostim patient experience."
APO VNNVF

Hot Stocks

08:11 EDT Apollo Global to provide EUR 1B capital solution to Vonovia - Apollo entered into agreements for Apollo-managed insurance affiliates, funds and other long-term investors to invest EUR 1 billion into an entity owning a portfolio of high-quality real estate assets in Northern Germany controlled by Vonovia, a leading global residential real estate company with assets of approximately $100 billion. This commitment follows a EUR 1 billion investment by Apollo funds in a Vonovia portfolio in Southwest Germany earlier this year. For Apollo, the transaction will allow its insurance and institutional clients to access an attractive investment opportunity backed by high-quality assets with resilient cashflow characteristics. The Northern Germany portfolio includes approximately 31,000 high-occupancy units valued by Vonovia at EUR 3.8 billion. Proceeds from the investment support Vonovia's capital allocation plans, including repayment of certain of its financial liabilities. The latest Vonovia portfolio investment is subject to the satisfaction of closing conditions, including regulatory clearances, and is expected to be completed by year-end.
TKLF

Hot Stocks

08:09 EDT Yoshitsu announces establishment of new subsidiaries in U.S. - Yoshitsu announced that it has established two new subsidiaries in the U.S., including Tokyo Lifestyle Holding Inc, a Delaware company incorporated on October 17, 2023, and REIWATAKIYA BOS. Through the establishment of the Subsidiaries, the Company aims to reinforce its business growth strategy in the U.S. market, advancing its expansion efforts globally and strengthening its ties with varied markets. The Subsidiaries enable the Company to operate directly in the U.S., which is expected to streamline the Company's international logistics and improve its cross-border communications. With a local U.S. presence, the Company believes that it is in a better position to adapt its management and training systems to meet the U.S. market demands. Mei Kanayama, the Principal Executive Officer of Yoshitsu, commented, "We believe that our decision to establish subsidiaries in the U.S. represents a step forward in strengthening our connection with our customers. We are committed to enhancing our service to U.S. customers, deepening our understanding of the U.S. market, and aligning our offerings more closely with the needs and preferences of U.S. customers. Through the establishment of the Subsidiaries, we expect to not only elevate our market share and brand presence in the U.S., but also foster our relationships with U.S. customers and enhance their interaction with us."
PROF

Hot Stocks

08:08 EDT Profound Medical announces CMS extension of temporary 'code' for TULSA - Profound Medical announced that, pursuant to the 2024 Final Rule published yesterday by the U.S. Centers for Medicare and Medicaid Services, CMS, use of HCPCS C code, C9734, previously established for the Hospital Outpatient Prospective Payment System, OPPS, has been extended for use in the Ambulatory Surgical Center, ASC, setting, and that MRI-Monitored Transurethral Ultrasound Ablation, TULSA, of prostate tissue, performed using Profound's TULSA-PRO system, has been assigned device-intensive status. The ASC extension will go into effect on January 1, 2024. "In June 2003, we announced that, with sponsorship and support from multiple physician specialty societies, the American Medical Association had established three new Current Procedural Terminology Category 1 codes for TULSA to treat prostate diseases," said Arun Menawat, CEO and Chairman of Profound. "Those permanent CPT Category 1 codes will go into effect on January 1, 2025. In the meantime, we are pleased that both U.S. hospitals and ASCs performing the TULSA procedure on Medicare patients will now be able to utilize the temporary C code, C9734."
JVA

Hot Stocks

08:07 EDT Coffee Holding says committed to merger with Delta Corp - Andrew Gordon, CEO, provided the following update: "I would like to provide a business update and an update regarding the proposed transaction with Delta Corp Holdings Limited to employees, shareholders and interested persons of Coffee Holding Co. First, let me begin by thanking our long-term loyal shareholders, supporters and interested persons for their patience and understanding over the past thirteen months. I, along with my board of directors, firmly believe this patience will be rewarded in the near future. Secondly, let me assure everyone that our management team and the management team of Delta are committed to this merger. Our management team believes the combination between our respective companies in terms of future revenue growth and subsequent earnings is projected by us to translate into a stronger stock price and value creation for our shareholders. The past two years have been difficult for our business. Following COVID-19 and the costly disposal of our under-performing Generations/Steep division, we encountered both a business slowdown and increasing costs, including the expensive relocation of manufacturing equipment to our current operating facilities in Colorado and Massachusetts. In addition, domestic freight costs remain elevated, and our borrowing costs have increased as short-term interest rates have risen significantly over the last 18 months. As a result of these factors, we have seen a significant drag on our earnings. With some of these challenges behind us, we believe we are looking at an improved outlook heading into 2024. We recently started shipping our products to two new large national supermarket chains along with a third larger regional chain which we believe dominates the Northeast market. These, along with new but smaller customer wins and improved sales of our flagship brand, Cafe Caribe, in the East Coast and Southwest, are expected to help grow our revenues by 18-25% in 2024 and drive a return to profitability. Coffee prices also remain at elevated levels on an historic basis, with smaller crops last year and remaining supply chain issues combining to keep nearby supplies tight. We have always recorded better results when similar conditions persisted in the past and it is our belief that will also be the scenario heading into our next fiscal year. Finally, I want to address our rationale behind the proposed merger with Delta and why we view this as the best course for the future of the Company and return for our shareholders. Although we believe that our business is on a more stable footing, several challenges persist. Financing costs are high, a situation that appears poised to continue for several years to come and capital market access has been restrictive for small companies such as ours even before the recent rise in interest rates. In addition, most other publicly traded coffee companies, other than retail coffee companies, have both underperformed and have gone relatively unnoticed in the public markets over the last several years and our company is no exception. To execute our growth initiatives, improve margins, and reduce our overhead and capital costs, it is the view of myself and the Company's board of directors that an increase in scale will be in our interests and that our Company and its shareholders would benefit from combining with a much larger enterprise such Delta. Delta is a global logistics company with a broad interest across commodities, industrials, and agricultural industries. It has experienced significant growth since its founding with revenues of over $620 million last year and today has over 400 employees in 17 countries. Delta's business lines are headed by experienced management teams and combining with Delta we believe will give us the scale and efficiency to execute our strategy. It is our belief that this will be the catalyst for setting the possibility of improved stock performance once we consummate the proposed merger. We are in the process of remaining stages in the review of our proxy statement with the Securities and Exchange Commission and expect to mail our proxy statement to our stockholders by year end and to hold our special meeting in the first quarter of 2024. Again, I want to thank our stockholders for your patience and your continued support."
SWAV

Hot Stocks

08:05 EDT ShockWave says CMS establishes Category I CPT add-on code for Coronary IVL - Shockwave Medical announced that as part of the Calendar Year 2024 Physician Fee Schedule final rule, the U.S. Centers for Medicare & Medicaid Services has established a Category I Current Procedural Terminology add-on code for procedures involving coronary Intravascular Lithotripsy. These updates will become effective January 1, 2024. The new CPT code, +92972, has been created to describe when coronary IVL is performed and has been assigned work Relative Value Units and professional fees that remunerate physicians for the additional work associated with performing coronary IVL. Because +92972 is an add-on code, the work RVUs and fees associated with coronary IVL will be added to the remuneration physicians receive for percutaneous coronary intervention procedures, including when atherectomy is also performed.
OVID

Hot Stocks

08:03 EDT Ovid Therapeutics expects cash to provide runway into 2026 - Ovid anticipates its cash runway should fund operations and its clinical development programs into 2026, after expected de-risking milestones for its current pipeline programs and following anticipated clinical results for soticlestat from Takeda. To support this strategy, management has executed several steps, including: received $30 million, non-dilutive capital infusion from Ligand in exchange for a minority interest in soticlestat's potential future milestone payments and royalties owed to Ovid; directing its resources toward anticipated high-value R&D activities, and seeking development collaborations for its novel molecules outside of Ovid's core areas and geographies of focus. Not reflected in its current runway guidance, Ovid retains eighty-seven percent of its interest in soticlestat's future milestones and royalties, which may provide significant additional non-dilutive capital to further fuel the Company and its pipeline.
PBLA

Hot Stocks

07:56 EDT Panbela Therapeutics announces exercise of warants, issuance of new warrants - Panbela Therapeutics entered into agreements with certain holders of its existing warrants exercisable for 2,130,000 shares of its common stock, in the aggregate, to exercise their warrants at a reduced exercise price of $0.78 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $1.9 million, before deducting financial advisory fees. The reduction in the exercise price of the existing warrants and the issuance of the new warrants was structured as an at-market transaction under Nasdaq rules. Roth Capital Partners is acting as the company's financial advisor for this transaction. In consideration for the immediate exercise of the existing warrants for cash and the payment of $0.125 per share underlying the existing warrants, the exercising holders will receive new warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended. Subject to the receipt of stockholder approval for the issuance of the underlying shares of common stock, the new warrants will be exercisable into an aggregate of up to 4,260,000 shares of common stock, at an exercise price of $0.78 per share and have a term of exercise equal to five years after stockholder approval.
CNSL

Hot Stocks

07:52 EDT Wildcat Capital urges Consolidated Communications to reject 'take private' deal - Wildcat Capital Management, which beneficially owns approximately 3M shares of Consolidated Communications Holdings, issued an open letter to CNSL's Board of Directors opposing the company's proposed transaction with affiliates of Searchlight Capital Partners, L.P. and British Columbia Investment Management Corporation, announced on October 16, 2023. Wildcat, the company's fifth-largest independent stockholder, said in its letter that it believes the takeover offer severely undervalues CNSL's equity. Based on its own analysis, Wildcat believes CNSL merits an enterprise value of approximately $4B, representing nearly a 30% premium to the $3.1B enterprise value implied by the proposed transaction at $4.70 per share. Wildcat continues to believe in the strategic value of the assets assembled by CNSL and the company's strong potential as a standalone entity, and called for CNSL to terminate the agreement if a higher price cannot be negotiated. Wildcat intends to vote its shares against the proposed transaction and strongly encourages CNSL's stockholders to do the same. Reference Link
CGAU

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07:47 EDT Centerra Gold announces TSX acceptance of renewed NCIB - Centerra Gold announced that the Toronto Stock Exchange has accepted its renewal of a normal course issuer bid to purchase for cancellation up to an aggregate of 18,293,896 common shares in the capital of the Company during the twelve-month period commencing on November 7, 2023 and ending on November 6, 2024, representing approximately 8.48% of Centerra's total issued and outstanding Common Shares, or 10% of the public float. As of October 31, 2023, Centerra had 215,807,212 issued and outstanding Common Shares. Under the NCIB, daily purchases would be limited to 191,219 Common Shares, other than purchases made under block purchase exemptions. Once the NCIB is commenced, the exact timing and amount of any purchases will depend on market conditions and other factors. Centerra will not be obligated to acquire any Common Shares and may suspend or discontinue purchases under the NCIB at any time. Any purchases made under the NCIB will be made at market price at the time of purchase through the facilities of the TSX and/or alternative Canadian trading systems in accordance with applicable securities laws and stock exchange rules. The Company's previous NCIB, in respect of which the Company sought and received approval from the TSX, authorized the purchase of up to 15,610,813 Common Shares and expired on October 12, 2023. A total of 5,298,200 Common Shares of the Company were repurchased through the facilities of the TSX and alternative Canadian trading systems at a volume weighted average price of C$7.44 per Common Share under the Company's previous NCIB.
ATNM...

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07:40 EDT Actinium Pharmaceuticals names Lynn Bodarky as Chief Business Officer - Actinium Pharmaceuticals (ATNM) announced that Lynn Bodarky has been named Chief Business Officer to lead the company's business development, licensing, and collaboration activities. Bodarky joins Actinium with over 25 years of proven business development and licensing experience at large global pharmaceutical and innovative biotechnology companies including Pfizer (PFE), Merck (MRK), Progenics and HiFiBiO. Over her career, she has executed a wide array of business transactions totaling over $5 billion in value across oncology, autoimmune and neurological indications.
CBOE

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07:37 EDT Cboe Global Markets backs FY23 revenue growth view 7%-9%, consensus $1.9B - Reaffirms High End of Organic Total Net Revenue Growth Range of 7%-9% in 2023; Reaffirms Data and Access Solutions Organic Net Revenue Growth Target of 7%-10%. Decreases 2023 Adjusted Operating Expense Guidance to $754M-$762M from $766M-$774M.
SNOA

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07:37 EDT Sonoma announces U.S. launch of pulse lavage irrigation treatment - Sonoma Pharmaceuticals announced the U.S. launch of its intraoperative pulse lavage irrigation treatment, which can replace commonly used IV bags in a variety of surgical procedures. Sonoma previously launched its pulse lavage irrigation treatment solution in Europe and is introducing this product to the United States at the Symposium on Advanced Wound Care Fall Conference in Las Vegas. Demonstrations will be available November 3-5 at booth 118. The product is expected to be ready for commercial use in the U.S. in November 2023
PAA

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07:36 EDT Plains All American raises FY23 adjusted EBITDA attributable to $2.60B-$2.65B - From $2.45B-$2.55B
ADES

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07:35 EDT Advanced Emissions enters framework for supply agreement with LSR - Advanced Emissions Solutions has entered into a framework for a definitive supply agreement with LSR seeking to address the growing European markets for products related to the purification and filtration of water, especially with regards to PFAS or "Forever Chemicals", as well as the growing market of micropollutants out of waste water. The proposed relationship will build on the existing capabilities and activated carbon production of ADES and the legacy network and expertise of LSR in the European market. ADES will be joining LSR at the world's leading water-related conference Aquatech in Amsterdam to further discuss the rationale and opportunity.
MRMD

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07:34 EDT Marimed CFO Susan Villare resigns, Jon Levine appointed interim - MariMed announced that effective October 31, 2023, SusanVillare resigned as CFO of the Company. The Board of Directors has appointed Jon Levine, President and CEO, as the Company's Interim CFO and has initiated a search process to identify and engage a new CFO.
SSP

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07:34 EDT E.W. Scripps sees Q4 local media revenue down low to mid-double digits - Sees Q4 Scripps networks revenue down in the 10% range.
REGN

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07:18 EDT Regeneron announces new, updated data from hematology pipeline at ASH meeting - Regeneron Pharmaceuticals announced that new and updated data from its hematology pipeline will be shared in 19 abstracts at the American Society of Hematology, ASH, Annual Meeting from December 9 to 12 in San Diego, CA. These include research across six investigational medicines that span eight difficult-to-treat blood cancers and disorders. Together, these presentations showcase the diversity of approaches Regeneron is advancing through its hematology pipeline and its dedication to leading-edge research. At ASH, 10 abstracts will feature updated data and analyses for Regeneron's most advanced investigational blood cancer medicine, odronextamab, in relapsed/refractory follicular lymphoma and R/R diffuse large B-cell lymphoma. Among them are three oral presentations from its pivotal trial, including: the final analysis in R/R DLBCL patients; a comprehensive analysis of minimal residual disease status and circulating tumor DNA profiling in R/R FL and DLBCL patients; and updated analyses and long-term follow-up of efficacy, safety and patient reported outcomes in R/R FL. Furthermore, the company will share long-term survival outcomes and a responder analysis for odronextamab from a Phase 1 trial in R/R DLBCL patients who have progressed after CAR-T therapy, a patient population who have a particularly dismal prognosis and limited effective treatment options.
AOTVF

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07:17 EDT Ascot Resources reports assay results from Premier Gold Project - Ascot Resources announced the third batch of assay results from the 2023 exploration drill program at the Company's Premier Gold Project, located on Nisga'a Nation Treaty Lands in the prolific Golden Triangle of northwestern British Columbia. This release summarizes the initial batch of assay results from this season's surface drilling program for in-fill and exploration purposes at the Big Missouri deposit, approximately six kilometres north of the Premier mill. Underground mine development commenced at Big Missouri in 2022, and crews are currently mining and stockpiling mineralized material as development advances. Highlights from the drill results include: 98.84 g/t Au over 6.48m from a depth of 51.5m in hole P23-2490, including 691.50 g/t Au over 0.90m. This is the all-time second highest-grade drill intercept at Big Missouri and is the Company's highest-grade drill intercept property-wide since 2015. 22.30 g/t Au over 9.72m from a depth of 58.3m in hole P23-2484, including 98.10 g/t Au over 1.91m 17.72 g/t Au over 5.65m from a depth of 21.4m in hole P23-2494, including 31.90 g/t Au over 1.60m Derek White, President and CEO of Ascot commented, "With underground mine development at Big Missouri having started last year, this is an opportune time to have intercepted some of the highest-grade gold mineralization in Ascot's history. In particular, the 692 gram-per-tonne intercept from hole P23-2490 is located in an area currently scheduled to be mined next year, and as such we are eager to exploit this material early in the mine life. Our surface drill program was recently completed, and we look forward to releasing assay results over the next several months."
ASLN

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07:17 EDT Aslan Pharmaceuticals presents new data on Eblasakimab - ASLAN Pharmaceuticals announced new data was presented at the Dermatology Drug Development Summit, DDDS, that took place in Boston, MA, from October 31 to November 2, 2023. The datasets presented strengthen evidence for eblasakimab's differentiated mechanism of action in atopic dermatitis, and, for the first time, show application in a new indication, chronic obstructive pulmonary disease, which can be driven by Type 2 inflammation. A head-to-head study between eblasakimab and dupilumab conducted in skin punch biopsies of AD patients showed differential expression of inflammatory cytokines secreted by the localized skin tissue, with eblasakimab treatment more efficiently reducing expression of Th2 cytokines IL-13, IL-4 and sCD40L, as well as IL-17F and chemokines CCL3 and CCL4, compared to dupilumab treatment. These preliminary results validate previously published data1 from AD patient peripheral blood mononuclear cells from ASLAN's research collaboration with Dr Shawn Kwatra and Dr Madan Kwatra. These data together demonstrate eblasakimab's differentiated effects compared to dupilumab and highlight the potential advantages to targeting IL-13R with eblasakimab, which may lead to more efficient blockade of Type 2 signaling while also sparing the Type 1 receptor. ASLAN also presented new data investigating the role of eblasakimab in COPD using an established ex vivo model of precision cut lung slices from human donors. The model tested airway hyperresponsiveness in the lung tissue using IL-4 and IL-13, the key Th2 cytokines involved in COPD disease pathology3. Eblasakimab significantly reduced IL-4 and IL-13-induced AHR by reducing airway constriction. Furthermore, IL-4 and IL-13 sensitized the airways to further constriction in response to methacholine, but this sensitization was blocked by eblasakimab treatment.
EGLX

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07:16 EDT Enthusiast Gaming's Luminosity returns to Rocket League - Enthusiast Gaming Holdings announced that Luminosity Gaming has returned to Rocket League after a one-year hiatus. In connection with its return, Luminosity Gaming has secured two of the top North American competitors and former OpTic Gaming team members Retals and MaJicBear, positioning Luminosity to be immediately competitive in the North American scene. Luminosity Gaming expects to add a third team member in the coming weeks.
HOWL

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07:16 EDT Werewolf present preliminary data from Phase 1/1b trial for WTX-124 - Werewolf Therapeutics announced preliminary first-in-human clinical data from initial monotherapy dose-escalation cohorts in the Company's lead clinical program, WTX-124x2101. This clinical program is an ongoing, multi-center Phase 1/1b clinical trial of WTX-124, Werewolf's interleukin 2 INDUKINE molecule, in patients with advanced or metastatic solid tumors. The preliminary data will be presented at the Society for Immunotherapy of Cancer's, SITC, 38th Annual Meeting in San Diego, California. The preliminary data include assessments of safety and tolerability, pharmacokinetics, relevant biomarkers and preliminary antitumor activity. Data as of the October 18, 2023, cutoff date are summarized as follows: WTX-124 was generally well-tolerated at all doses tested up to and including 12 mg in the outpatient setting. WTX-124 showed expected pharmacokinetics with evidence of wide therapeutic index allowing for continued dose escalation. WTX-124 demonstrated both translational biomarker activity and early evidence of monotherapy antitumor activity at 6 mg and 12 mg doses. In addition, five preclinical posters further supporting the INDUKINE hypothesis, WTX-124 properties, and other INDUKINE molecules are being presented at the meeting, including: Title: PK/RO Modeling of WTX-124, a Tumor-Activated IL-2 Prodrug, Highlights the Potential for a Substantially Improved Therapeutic Index Compared to Other IL-2 Molecules. Plasma and tumor data from mice were used to perform pharmacodynamic and receptor occupancy modeling to predict IL-2 receptor occupancy on peripheral lymphocytes and tumor infiltrating lymphocytes suggesting WTX-124 has a substantially improved, best-in-class therapeutic index as compared to other IL-2 molecules investigated. Title: Optimal Antitumor Immunity Triggered by WTX-124, a Clinical Stage Conditionally Activated INDUKINETM Molecule that Releases Fully Potent IL-2 in the Tumor Microenvironment. WTX-124 generated robust anti-tumor activity in a MC38 tumor bearing mouse model and promoted the expansion and activation of tumor specific CD8+ T cells as compared to a variant Non-Alpha IL-2 containing INDUKINE molecule. Title: Spatial Analysis of Tumor Infiltrating Lymphocyte Populations in Syngeneic Mouse Tumor Models After Treatment with IL-12 and IL-2 INDUKINETM Molecules. Combination treatment with WTX-124 and alpha PD-1 generated robust anti-tumor activity in a CT26 model resulting in widespread tumor infiltration by CD8+ T cells driving immune activation in the tumor microenvironment. Title: The Combination of ACT and INDUKINETM Therapy Leads to Improved Antitumor Immunity in Solid Tumors. Systemic WTX-124 was shown to preferentially expand CD4 CAR T cells while WTX-330 expanded CD8 CAR T cells, demonstrating that the administration of INDUKINE proteins with adoptive cell therapy could reinvigorate donor cell function leading to improved immunity, engraftment and long-term responses in solid tumors. Title: Development of WTX-712, a Conditionally Activated IL-21 INDUKINETM Molecule for the Treatment of Cancer. WTX-712 was shown to be peripherally inactive in preclinical studies, releasing IL-21 selectively within the tumor microenvironment while driving CD8+ T cell polyfunctionality and promoting immune cell interactions.
DIIBF

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07:15 EDT Dorel Industries sees continued quarter-over-quarter earnings improvement - "Our outlook at the end of the second quarter for continued quarter-over-quarter earnings improvement was valid for the third quarter and remains so going forward. At Dorel Juvenile, market share data confirms that we are gaining sales at the expense of the competition with our new, innovative product that is resonating well with consumers. While we are concerned by the economic environment in which we are operating, we remain focused on bringing winning products to the marketplace, partnering with our retail customers, and investing in e-commerce to ensure that the progress so far this year continues for the balance of 2023 and in to 2024," commented Dorel President & CEO, Martin Schwartz. "While the results at Dorel Home are less positive, sales are improving across the year, and we are narrowing our losses. We are operating in a challenging environment, slowing the pace of our turnaround, but we expect to deliver an operating profit as soon as the fourth quarter of this year, setting the table for a much better performance in 2024," concluded Mr. Schwartz.
GNS

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07:13 EDT Genius Group partners with Daily.ai to deliver AI-powered news via GeniusU.com - Genius Group announces that it has partnered with Daily.ai to deliver AI-powered Email Newsletters to GeniusU's students, partners and subscribers. Genius Group, through its Edtech platform GeniusU Ltd, has agreed to a partnership with Daily.ai whereby they are converting their weekly Genius News which delivers the latest news on entrepreneur education, the future of work, and developments within exponential technologies into an AI-generated newsletter powered by Daily.ai. CEO of Genius Group, Roger Hamilton, said "Daily.ai is leading the way in AI-powered news, and their AI Email Newsletters have attracted a client base of world-class influencers and thought leaders. We're excited to be partnering with them to deliver their tools to our educators, and this will be an excellent complement to the AI educator solution we are delivering via GeniusU."
PSTV

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07:12 EDT Plus Therapeutics granted Orphan Drug Designation for rhenium obisbemeda - Plus Therapeutics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to rhenium obisbemeda for the treatment of breast cancer with leptomeningeal metastases. Rhenium obisbemeda is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. Cohort 4 of the ReSPECT-LM trial recently completed enrollment, and the Company anticipates moving into Cohort 5 following standard safety review. Updates on the ReSPECT-LM trial will be presented at the Society for Neuro-Oncology Annual Meeting November 15-19, 2023. In addition to ODD, the FDA previously granted rhenium obisbemeda Fast Track designation for the treatment of LM.
RPID

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07:08 EDT Rapid Micro Biosystems expects cash to fund operations into at least 2026 - Cash, cash equivalents and investments were $104.0 million as of September 30, 2023, which the Company continues to expect to provide a cash runway at least into 2026. The Company had no debt outstanding as of September 30, 2023.
MORF

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07:05 EDT Morphic expects cash to fund operations through second half of 2027 - Ended third quarter with $725.1 million in cash, cash equivalents, and marketable securities providing runway into the second half of 2027.
LEV

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07:04 EDT Lion Electric receives conditional purchase order from Highland - The Lion Electric announced that it has received a conditional purchase order for 50 all-electric LionC school buses from Highland Electric Fleets, a leading provider of Electrification-as-a-Service for school districts, governments, and fleet operators in North America. The purchase order is conditional upon the satisfactory grant of non-repayable contributions to Highland under Infrastructure Canada's Zero-Emission Transit Fund. The new buses are intended to be used on school routes in Alberta, Canada, serviced by Rental Bus Lines.
HUT

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06:52 EDT Hut 8 Mining gets court approval for stalking horse bud for natural power plant - Hut 8 Mining announced that the Ontario Superior Court of Justice has approved a stalking horse bid as part of the previously announced support agreement with Macquarie Equipment, a subsidiary of Macquarie Group, a global financial services group. In connection with the Stalking Horse Bid, the court has also approved the implementation of a sale and investment solicitation process to be carried out by KSV Restructuring. The SISP is being conducted in respect of the sale of certain assets of Validus Power and the assets and operations of certain Validus' subsidiaries. If the Stalking Horse Bid is ultimately declared the successful bid in the SISP, as further approved by the court, and completed in accordance with its terms, a new Ontario subsidiary of the company will become the owner of the assets of certain Validus Entities. Macquarie will receive a minority equity interest in BidCo of approximately 20% and a subsidiary of Hut 8 will be the majority owner with the remaining approximately 80%. On completion of the Stalking Horse Bid in accordance with the SISP, BidCo would acquire, free and clear of any encumbrances four natural gas power plants located in Ontario.
BLMN

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06:47 EDT Bloomin' Brands reports Q3 combined U.S. comparable restaurant sales (0.5%)
EAF

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06:45 EDT GrafTech expects weak near term demand for graphite electrodes - Sees FY23 LTA revenue $245M-$255M and FY24 LTA revenue $100M-$135M. The company said, "We expect demand for graphite electrodes in the near term will remain weak, reflecting persistent softness in the commercial environment as steel industry production remains constrained by global economic uncertainty. As a result, sales volume in the fourth quarter of 2023 is expected to decline modestly compared to sales volume in the Q3 of 2023. We expect our cash cost of goods sold per MT in the Q4 of 2023 will be below the level recognized in the Q3 of 2023, but will be higher compared to the Q4 of 2022. As a result, for the FY23, we continue to expect a significant year-over-year increase in our cash cost of goods sold per MT as fixed costs are recognized over a smaller volume base, excess fixed costs that would have otherwise been inventoried are recognized when incurred due to reduced production levels and reflecting the full-year impact of higher raw material costs that increased throughout 2022. We continue to closely manage our operating costs and capital expenditures, as well as our working capital levels. ooking ahead, we remain confident in our ability to overcome near-term challenges and are optimistic about the long-term outlook for our business. We anticipate the steel industry's accelerating efforts to decarbonize will lead to increased adoption of the electric arc furnace method of steelmaking, driving long-term demand growth for graphite electrodes. We also anticipate the demand for petroleum needle coke, the key raw material we use to produce graphite electrodes, to accelerate driven by its utilization in producing synthetic graphite for use in lithium-ion batteries for the growing electric vehicle market. We believe that the actions we are taking, supported by a distinct set of capabilities, including our substantial vertical integration into petroleum needle coke via our Seadrift facility, will optimally position GrafTech to benefit from these sustainable industry tailwinds."
MKTX

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06:40 EDT MarketAxess reports October total credit ADV of $12.7B, up 1.8% y/y - Up 7.6% versus September 2023 levels.
ASIX

Hot Stocks

06:34 EDT AdvanSix sees FY23 CapEx about $115M - For FY23: Expect nylon industry margins to remain at prior trough levels through year-end due to unfavorable supply and demand conditions; Anticipate continued higher Nylon Solutions exports in near-term. Expect favorable underlying agriculture industry fundamentals to continue. Expect balanced supply and demand conditions for North American acetone to continue. Capital Expenditures tracking to approximately $115M for the full year 2023, reflecting increased spend due to critical infrastructure, other maintenance, and growth and cost savings projects. "To drive long-term, sustainable performance, we are focusing our resources and efforts around higher value components of our portfolio. Simplification reduces complexity to ensure our investments and resources are aligned with supporting our customers' success in areas of highest impact. Of note, we are accelerating profitable growth through our SUSTAIN program's planned expansion in granular ammonium sulfate production. We're committed to driving best possible outcomes in the current set of industry dynamics and executing levers in our control, including remaining disciplined on cost and optimizing working capital to create shareholder value," concluded CEO Kane.
ENSG

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06:07 EDT Ensign Group acquires Champions Healthcare at Willowbrook - The Ensign Group, the parent company of the Ensign group of companies, announced that it acquired the real estate and operations of Champions Healthcare at Willowbrook, a healthcare campus consisting of a 98-bed skilled nursing facility and a 144-bed assisted living facility located in Houston, Texas. The real estate was acquired by a subsidiary of Standard Bearer Healthcare REIT, Inc., Ensign's captive real estate company, and the acquisition was effective November 1. This acquisition brings Ensign's growing portfolio to 297 healthcare operations, 27 of which also include senior living operations, across thirteen states. Ensign subsidiaries, including Standard Bearer, own 113 real estate assets.
FLR

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06:04 EDT Fluor selected by BHP Canada to develop stage two of potash project - Fluor has been selected by BHP Canada to develop Stage 2 of its multibillion-dollar Jansen potash project in Saskatchewan, Canada. Fluor expects to recognize its undisclosed reimbursable contract value in the fourth quarter of 2023.
ARM

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05:53 EDT Arm to make strategic investment in Raspberry Pi, acquires minority stake - Arm Holdings and Raspberry Pi Ltd on Thursday announced an agreement by Arm to make a strategic investment in Raspberry Pi. Arm has acquired a minority stake in Raspberry Pi, further extending a long-term partnership between the two companies as they collaborate to deliver solutions for the Internet of Things developer community. "Arm and Raspberry Pi share a vision to make computing accessible for all, by lowering barriers to innovation so that anyone, anywhere can learn, experience and create new IoT solutions," said Paul Williamson, SVP and GM, Internet of Things Line of Business, Arm. "With the rapid growth of edge and endpoint AI applications, platforms like those from Raspberry Pi, built on Arm, are critical to driving the adoption of high-performance IoT devices globally by enabling developers to innovate faster and more easily. This strategic investment is further proof of our continued commitment to the developer community, and to our partnership with Raspberry Pi." Reference Link
MSFT

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05:50 EDT Microsoft announces Secure Future Initiative to advance security engineering - On Thursday, Microsoft announced the Secure Future Initiative, which includes responding faster to vulnerabilities and using AI and automation to improve software security. Vice Chair and President Brad Smith said in a blog post: "Satya Nadella, Microsoft Chief Executive Officer; Rajesh Jha, Microsoft Executive Vice President, Experiences and Devices; Scott Guthrie, Microsoft Executive Vice President, Cloud and AI; and I have put significant thought into how we should anticipate and adapt to the increasingly more sophisticated cyberthreats. We have carefully considered what we see across Microsoft and what we have heard from customers, governments, and partners to identify our greatest opportunities to impact the future of security. As a result, we have committed to three specific areas of engineering advancement we will add to our journey of continually improving the built-in security of our products and platforms. We will focus on 1. transforming software development, 2. implementing new identity protections, and 3. driving faster vulnerability response." The Secure Future Initiative "Improve security for customers both in the near term and in the future, against cyberthreats we anticipate will increase over the horizon." Smith said Microsoft will "transform the way we develop software with automation and AI," and the company "must continue to enable customers with more secure defaults to ensure they have the best available protections that are active out-of-the-box." Reference Link
INFY

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05:17 EDT Infosys announces new proximity center in Bulgaria - Infosys announced a new proximity center in Sofia, Bulgaria as part of its continued growth in Europe. In line with Infosys' strategy to amplify human potential hiring local talent, the new center will enable Infosys to attract, re-skill, and up-skill 500 new employees. Over the course of the next four years, these new employees will work on global opportunities around next-gen digital technologies including Infosys Cobalt Cloud Solutions, Infosys Topaz AI & Automation, Data and Insights, IoT, 5G, and software engineering.