Stockwinners Market Radar for November 03, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:24 EDT Avita Medical announces FDA breakthrough device designations for Recell - The company states: "AVITA Medical announced that the FDA granted the RECELL System designations as a Breakthrough Device for its proposed soft tissue repair indication as well as its vitiligo indication. The goal of the FDA Breakthrough Devices Program is to provide patients and health care providers with timely access to new medical devices and technologies by expediting the development, assessment, and review of devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase."

18:49 EDT LGI Homes reports 797 home closings in October - LGI Homes "announced it closed 532 homes in October 2022. As of October 31, 2022, the Company had 92 active selling communities."

18:31 EDT Iveric bio submits first part of NDA for rolling review of avacincaptad pegol - Iveric bio announced that it has submitted to the U.S. Food and Drug Administration the first part of its New Drug Application for rolling review of avacincaptad pegol a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy secondary to Age-Related Macular Degeneration. As previously announced, the company received Fast Track designation from the FDA for ACP. Following receipt of the topline GATHER2 data, the company shared the data with the FDA. Based on the pivotal clinical trials, GATHER1 and GATHER2, which both met their primary endpoint in slowing GA progression with statistical significance at the 12-month time point, the Company requested rolling submission of its planned NDA, which the FDA granted. As per the Company's agreement with the FDA, the first part of the NDA, which included the complete ACP clinical data package, was successfully submitted earlier today. "We are pleased to report this important milestone and look forward to closely collaborating with the FDA throughout the review of our NDA," said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "As we stated previously, our Special Protocol Assessment (SPA) agreement with the FDA provides a basis for review of our NDA based on 12-month safety and efficacy results from GATHER2, taken together with the results of GATHER1."

18:10 EDT Latam Airlines completes financial restructuring process in U.S. - Latam Group announced that it successfully completed its financial restructuring process in the United States, which it voluntarily commenced in May 2020 to reduce its debt, access new sources of financing, and transform its business in response to the global pandemic. Having maintained its position while achieving significant cost savings, LATAM has emerged from the reorganization as a more efficient group, with a modernized fleet, the most extensive network of connections in South America, and the continent's largest loyalty program, the company said. With over $2.2 billion of liquidity, approximately $3.6B less debt on its balance sheet (equivalent to a 35% debt reduction from the pre-filing period), and the support of key incumbent and new shareholders, LATAM is poised to reaffirm its leadership in Latin America and has positioned itself for long-term sustainability, the company added. "Today marks an important milestone for LATAM and our stakeholders. We are pleased that we have completed a significant transformation and emerged from our financial restructuring process with a strengthened financial position and a renewed commitment to operational excellence. As a group with a dynamic team of 30,000 employees and an unrivaled connectivity network, we look forward to continuing to offer passengers the best alternative for travel to, from, and within South America and to contribute in the broader sense to the various countries in which we operate and their diverse interests" said Roberto Alvo, CEO of LATAM Airlines Group.

17:58 EDT Arrival Group receives noncompliance notification from Nasdaq - Arrival received a notification from Nasdaq that the company no longer satisfies Nasdaq Listing Rule 5450(a)(1) because the closing bid price of the company's ordinary shares was below $1.00 per Share for 30 consecutive business days preceding the date of the Notification.

17:46 EDT Starbucks says retention has increased for baristas - Seeing healthy growth in North America business.

17:40 EDT Topgolf Callaway jumps 4% to $18.13 after Q3 earnings beat, guidance raise

17:37 EDT Trupanion to acquire Royal Blue, terms undisclosed - Trupanion announced the signing of a definitive agreement to acquire Royal Blue, the parent company of PetExpert. There are an estimated 1,300 veterinary hospitals in the Czech Republic and Slovakia and over 95% of these have connectivity to the PetExpert platform. The transaction is expected to close in the fourth quarter of 2022 and no additional terms were disclosed. Trupanion does not anticipate a material financial impact to its 2022 financial results as a result of this acquisition.

17:31 EDT Beacon raises FY22 revenue view to up 23%-25% from up slightly above 20% - Consensus $8.31B. Sees FY22 adjusted EBITDA $885M-$910M. Says expects solid finish to 2022 including the benefits of the acquisition of Coastal Construction Products. Says October 2022 sales per day were up high 20% range. Sees Q4 sales per day up 15%-17%% YoY. Says assumes normal fourth quarter seasonality while lapping record November and December results. Says Q4 gross margins expected to be 25%-25.5%. Says expects significant cash flow conversion in Q4. Says balancing product availability and inventory reduction as well as productivity focus and investing for growth. Comments and guidance taken from Q3 investor presentation slides.

17:21 EDT TPI Composites extends supply pact with ENERCON in Turkiye through 2025 - TPI Composites announced that it has extended its supply agreement with ENERCON in Turkiye through 2025 in support of ENERCON's domestic projects in Turkiye and export projects."We are pleased to announce this extension of our contract in our Izmir, Turkiye facility and continuation of our strong partnership with ENERCON," said Bill Siwek, President and CEO of TPI."It is of great pleasure to reaffirm our strong business partnership with TPI and look forward to continuing our collaboration to support ENERCON's ambitions for local projects in Turkiye, as well as projects within Europe. The last years of cooperation have a proven track record of outstanding teamwork and will safeguard ENERCON in having competitive and robust supply for our projects," said Heiko Juritz, CPO of ENERCON.TPI has manufactured wind blades for ENERCON in Turkiye since 2018.

17:14 EDT GoPro sees FY23 gross margin at the low end of 40%-43% in constant currency

17:10 EDT Kimbell Royalty Partners to acquire interests in Hatch Royalty for $290M - Kimbell Royalty Partners announced that it has agreed to acquire mineral and royalty interests held by Austin-based Hatch Royalty in a cash and unit transaction valued at approximately $290M, subject to purchase price adjustments and other customary closing adjustments. The purchase price for the Acquisition is comprised of $150M in cash, approximately 52% of the total consideration, and approximately 7.3M common units of Kimbell Royalty Operating, which are valued at $140M, approximately 48% of the total consideration. Kimbell estimates that, as of October 1 the acquired assets produce approximately 2,072 Boe/d. The Board of Directors of Kimbell's general partner and the governing bodies of Hatch have each unanimously approved the Acquisition, which is expected to close in the Q4, subject to customary closing conditions. The effective date of the Acquisition is expected to be October 1, 2022.

17:03 EDT Expedia CFO says will further delever balance sheet - CFO Julie Whalen says: "Overall, we are pleased to see strong demand expand into the fourth quarter as consumers continue to prioritize travel spend over other discretionary spending. And while it is still early in the quarter, we are seeing total lodging bookings for stays expected to occur in the balance of the year and into 2023, continuing to outpace 2019 levels... As we move forward, given our strong liquidity, our confidence in the business and the fact our stock continues to be highly undervalued, we expect to further delever the balance sheet and continue returning capital to shareholders in the form of share buybacks. In summary, our third quarter results demonstrate some of the early wins we are starting to see from the transformation of the business and the success of our strategic growth initiatives. These early wins give us confidence that a huge opportunity in front of us to drive long-term profitable growth and to maximize shareholder value." Comments taken from Q3 earnings conference call.

16:58 EDT Prothena sees FY22 net cash burn of $108M-$120M, up from $120M-$132M - Prothena states: "The Company is updating its projected full year 2022 net cash burn from operating and investing activities, and expects it to be $108 to $120 million (versus prior guidance of $120 to $132 million) which includes an expected $40 million clinical milestone payment from Novo Nordisk, and expects to end the year with approximately $522 million in cash, cash equivalents, and restricted cash (midpoint) (versus prior guidance of $454 million) which is primarily driven by operating and financing activities. The updated estimated full year 2022 net cash burn from operating and investing activities is primarily driven by an updated estimated net loss of $121 to $137 million (versus prior guidance of $154 to $170 million), which includes an estimated $31 million of non-cash share-based compensation expense."

16:56 EDT Accenture names Andrew Levy chief corporate, government affairs officer - Accenture has appointed Andrew J.P. Levy to the newly created position of chief corporate and government affairs officer. In this newly created role, Levy will lead the company's geopolitical strategic analysis and its global government relations function, as well as a global network of external strategists and advisors in this area. Levy has been with Accenture for more than 10 years, most recently serving as the company's general counsel for Growth Markets, based in Hong Kong and Singapore. Prior to joining Accenture, Levy held other regional and global legal roles for Accenture. Previously, he was an attorney with Paul, Weiss, Rifkind, Wharton & Garrison LLP in New York and Washington, D.C., and served as deputy general counsel for the U.S. Department of Homeland Security. "Assessing geopolitical trends and working effectively with governments and thought leaders around the world has never been more important," said Joel Unruch, general counsel and corporate secretary at Accenture. "Andrew's international experience and political and legal background make him perfectly suited for this new and extremely important role."

16:55 EDT Fidelity National raises quarterly dividend to 45c from 44c per share - The dividend will be payable December 30 to stockholders of record as of December 16.

16:53 EDT Akebia reaffirms FY22 net product revenue guidance of $170M-$175M - "Managing operating expenses is critical as we look for opportunities to add value to the company," said David A. Spellman, CFO. "By focusing on operating expenses and winding down certain projects, we're pleased to report a reduction in spend quarter over quarter in 2022. Auryxia net product revenue increased in the Q3 from the Q3 of 2021. There was a slight decline from the Q2 partially due to the drawdown of inventory at certain customers during the Q3. In addition, since the start of COVID, the phosphate binder market has contracted 15%. While the phosphate binder market has continued to decline, the work we've done to increase net price per pill puts us in a position to affirm our 2022 net product revenue guidance for Auryxia of $170M- $175M."

16:47 EDT Bill.com to acquire Finmark, terms not disclosed - Bill.com announced it has signed a definitive agreement to acquire Finmark, a financial planning software provider that simplifies financial planning and cash flow insights for SMBs. Finmark's intuitive financial planning solution makes it easy for SMBs to analyze their business holistically, turn insights into decisions, and forecast with confidence. Accounting firms also use Finmark's software to automate many of the processes involved in providing additional strategic client advisory services, including forecasting and cash flow management. "We are building the essential financial operations platform for SMBs," said Irana Wasti, BILL Chief Product Officer. "The acquisition of Finmark adds a powerful planning and cash flow analytics tool for SMBs and brings a very talented team to BILL. Finmark's innovative software provides businesses with automated tools to build financial forecasts based on integrated data. This tool, together with our platform and data, will further empower SMBs to manage their businesses and cash flow." The transaction has been approved by the Boards of Directors of both Finmark and BILL, and is expected to close by the end of this calendar year, subject to customary closing conditions. Terms of the acquisition were not disclosed.

16:46 EDT Syndax lowers FY22 research and development expenses view to $115M-$125M - The company said, "For the FY22, the Company is lowering its expectations of both research and development and total operating expenses. The Company now expects research and development expenses to be $115M-$125M and total operating expenses to be $145M-$155M. This is a reduction from the Company's prior guidance for the FY22 of $130M-$140M in research and development expenses and $160M-$170M in total operating expenses. The updated guidance reflects the benefits derived from the shared expenses for our axatilimab cGVHD development program. In September, Syndax made a debt repayment in connection with the termination of a Loan Agreement. This loan repayment has no adverse impact on Syndax's cash guidance and the Company continues to expect to have sufficient capital to fund operations into the second half of 2024."

16:38 EDT Floor & Decor reports Q3 SSS up 11.6%

16:33 EDT Select Medical board authorizes $1B share buyback program - The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $1B worth of shares of its common stock. The common stock repurchase program will remain in effect until December 31, 2023, unless further extended or earlier terminated by the board of directors.

16:29 EDT Monster Beverage announces new $500M share repurchase program - The company announced that its board of directors has authorized a new share repurchase program for the repurchase of up to an additional $500M of the company's outstanding common stock. The company expects to make the share repurchases from time to time in the open market, through privately-negotiated transactions, by block-purchase or through other transactions managed by broker-dealers or otherwise, subject to applicable laws, regulations and approvals. The timing of the share repurchases will depend on a variety of factors, including market conditions, and the share repurchases may be suspended or discontinued at any time.

16:24 EDT PayPal working with Apple to enhance offerings for PayPal and Venmo merchants - PayPal said: "Working with Apple to enhance our offerings for PayPal and Venmo merchants and consumers: Leveraging Apple's Tap to Pay on iPhone technology, U.S. merchant customers will soon be able to accept contactless debit or credit cards and mobile wallets, including Apple Pay, using an iPhone and the PayPal or Venmo iOS app; Adding Apple Pay as a payment option in PayPal's unbranded checkout flows on merchant platforms, including the PayPal Commerce Platform; Next year, U.S. customers will be able to add PayPal and Venmo network-branded credit and debit cards to Apple Wallet and use them anywhere Apple Pay is accepted." PayPal added that Venmo is now live as a new payment option for select Amazon (AMZN) customers; ramping to full availability for U.S. Amazon customers this holiday season.

16:23 EDT Legend Biotech announces seven studies accepted for presentation at ASH - The company states: "Legend Biotech announced that seven company-sponsored studies were accepted for presentation at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans. The presentations deliver the latest on the clinical development program for ciltacabtagene autoleucel, the B-cell maturation antigen -directed chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of multiple myeloma. The poster presentations will detail an analysis from the Phase 1b/2 CARTITUDE-1 study assessing patients with sustained minimal residual disease negativity (greater than or equal to6 months, and greater than or equal to12 months), as well as updated data from CARTIFAN-1, a Phase 2 confirmatory trial of cilta-cel in China for the treatment of heavily pretreated Chinese patients with relapsed or refractory multiple myeloma. This is the first time that data from CARTIFAN-1 will be presented at a conference. Longer-term follow-up data from the ongoing multicohort Phase 2 study, CARTITUDE-2, will also be presented, communicating results from Cohort B, which is comprised of patients who had early relapse and Cohort C, which includes patients with progressive multiple myeloma and previous exposure to a non-cellular anti-BCMA immunotherapy. The study design of CARTITUDE-6/EMagine will also be presented at the meeting. This Phase 3 study seeks to evaluate the safety and efficacy of daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) followed by cilta-cel vs DVRd followed by ASCT in newly diagnosed multiple myeloma patients."

16:22 EDT Hannon Armstrong sees annual distributable EPS up at CAGR of 10%-13% - The company expects that annual distributable earnings per share will grow at a compounded annual rate of 10% to 13% from 2021 to 2024, relative to the 2020 baseline of $1.55 per share, which is equivalent to a 2024 midpoint of $2.40 per share. The company also expects growth of annual dividends per share to be at a compounded annual rate of 5% to 8%.

16:16 EDT Coterra Energy reports Q3 production 641 Mboepd - Natural gas production averaged 2,807 MMcfpd, exceeding the high-end of guidance. Oil production averaged 87.9 MBopd, above the mid-point of guidance.

16:14 EDT Block says gross profit up 37% year-over-year in October - Block gross profit excluding BNPL was up 24% year-over-year in October, the company said in its quarterly letter.

16:12 EDT ATSG sees FY22 adjusted EBITDA to meet or exceed $640M - ATSG expects its capital spending for 2022 will be $625 million, including $195 million in sustaining capex and $430 million for growth. Growth capex will be funded primarily by the strong Adjusted Free Cash Flow ATSG is generating this year. "We are on schedule to meet our targets, as demand for our express-package network assets and flight operations remains strong. We are ready to operate under expanded peak holiday-season flight schedules for our CMI customers, supporting fulfillment of higher e-commerce shopping spurred by special early-season promotions. We anticipate growth in ATSG's cash flow through the current economic cycle and beyond," he said.

16:07 EDT Starbucks reports Q4 global SSS up 7% - Global comparable store sales increased 7%, primarily driven by an 8% increase in average ticket. North America and U.S. comparable store sales increased 11%, driven by a 10% increase in average ticket and a 1% increase in comparable transactions. International comparable store sales decreased 5%, driven by a 5% decline in comparable transactions and a 1% decline in average ticket; China comparable store sales decreased 16%, driven by a 17% decline in comparable transactions, partially offset by a 1% increase in average ticket. The company opened 763 net new stores in Q4, ending the period with 35,711 stores globally: 51% company-operated and 49% licensed.

16:03 EDT MFIC Corporation increases quarterly dividend to 37c per share - The board of directors declared a dividend of 37c per share payable on January 5, 2023 to shareholders of record as of December 19.

15:55 EDT Alerus Financial raises dividend 12.5% YoY to 18c per share - Alerus Financial announced that its board of directors declared a regular quarterly cash dividend of 18c per common share, a 12.5% increase over the dividend paid a year ago. The dividend is payable on January 13, to shareholders of record as of close of business on December 23. Current and historic dividend information, as well as quarterly financial statements, investor presentations, and earnings call transcripts are available online through Alerus' investor relations website at investors.alerus.com.

15:45 EDT StoneCo announces Pedro Zinner to succeed Thiago Piau as CEO - StoneCo announced that Thiago Piau, the current CEO, will become a Board member of the company, where he will focus his attention on developing key strategic and financial initiatives to help drive the future expansion of StoneCo. Pedro Zinner, a current Board member of StoneCo, will step-down from the Board and succeed Piau as CEO. Zinner will join Stone's executive team no later than March 31st, 2023 and will begin working closely with Piau and the management team in a transition period before taking on the CEO role. Zinner was most recently the CEO of Eneva, one of the leading power-generation companies in Brazil, from 2017 to November 2022.

14:40 EDT Petrobras trading resumes

14:09 EDT NY Attorney General James secures $523M from Teva for opioid crisis claims - New York Attorney General Letitia James today marked a monumental milestone in her fight against the opioid crisis in New York state and announced that her office has secured up to $523M from Teva Pharmaceuticals , its American subsidiary Teva Pharmaceuticals USA, and its affiliates for their role in fueling the opioid crisis. The $523M settlement is the largest reached with an individual opioid defendant by Attorney General James and raises the total amount secured from opioid manufacturers and distributors to more than $2B to combat the opioid crisis. The settlement resolves Attorney General James' claims against Teva, the final remaining defendant not currently in bankruptcy and concludes the Attorney General's litigation against opioid manufacturers and distributors. "Teva knowingly and intentionally misled New Yorkers and the American people about the deadly dangers of opioids, and last year, a jury found them responsible for the devastation and destruction they have caused," said Attorney General James. "You cannot put a price on lives lost, addiction suffered, and families torn apart, but with the more than $2B we have now delivered to New Yorkers, we can continue to rebuild and recover. I made a promise to put an end to the havoc wreaked by opioid manufacturers in New York and across the nation and to hold them accountable for the consequences. This is a landmark day in our battle against the opioid crisis, and I am proud to be able to deliver critical funding and resources to the communities Teva and other companies ravaged with their rampant misconduct." Reference Link

13:50 EDT Merus falls after FDA recommends additional enrollment in Zeno study - Shares of clinical-stage oncology company Merus are down 34% or approximately $7 per share on Thursday, to $13.56 per share, after indicating that after a recent meeting with the FDA on "potential Biologics License Application, or BLA filing forZenocutuzumab or Zeno in NRG1 fusion cancer. "Based on the FDA feedback, Merus believes that a potential registrational path remains viable in a NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a potential tumor agnostic filing. The majority of the eNRGy trial and Early Access Program enrollment to date has been NRG1+ non-small cell lung cancer and NRG1+ pancreatic cancer. The FDA recommended that Merus enroll additional patients under either approach , to obtain further supportive data for a potential registrational data set, consistent with the recent FDA draft guidance on Tissue Agnostic Drug Development in Oncology. The amount of data needed for a potential filing under either approach will depend upon the magnitude and durability of responses and the overall risk benefit assessment." said the company in a statement

13:04 EDT NGM Biopharmaceuticals to present post-hoc analyses from CATALINA trial - NGM Biopharmaceuticals announced the presentation of findings from post-hoc analyses of its randomized, double-masked, sham-controlled CATALINA Phase 2 trial of NGM621, a monoclonal antibody designed to inhibit activity of complement component 3, in patients with GA secondary to AMD at The Retina Society Annual Scientific Meeting taking place November 2 - 5, 2022 in Pasadena, Calif. The presentation, given by Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Texas and an investigator for the CATALINA trial, included a summary of topline findings, as previously reported by NGM Bio, in addition to results from post-hoc analyses undertaken to further interpret the CATALINA study results. The primary efficacy endpoint of the CATALINA trial was the rate of change in GA lesion area, as measured by fundus autofluorescence imaging, over 52 weeks of treatment. As previously reported, over 52 weeks of treatment, NGM621 administered every four weeks and every eight weeks via intravitreal injection demonstrated a reduction in the rate of change in GA lesion area (slope) of 6.3% and 6.5%, respectively, compared to sham, which did not reach statistical significance in either arm. One of the post-hoc analyses presented at the Retina Society meeting involved the evaluation of a sub-population of patients least likely to be impacted by FAF grading limitations: those in the middle two quartiles of a quartile analysis based on baseline lesion area. The patients in this sub-group had baseline GA lesions measuring 4.17 - 9.64 mm2 as compared to study inclusion criteria of baseline GA area between greater than or equal to2.5 mm2 and less than or equal to17.5 mm2. In this analysis, NGM621 demonstrated a reduction in the rate of change in GA lesion area of 21.9% and 16.8%, compared to sham. Using MMRM analysis with the adjusted treatment arm, the reduction in change from baseline in GA at 52 weeks was 20.6% and 16.6.%. NGM621 was discovered by NGM Bio under its strategic collaboration with Merck, known as MSD outside the United States and Canada.

13:02 EDT American Axle trading resumes

13:00 EDT American Axle jumps 13% to $10.31 after Bloomberg takeover interest report

12:28 EDT Amazon pauses new corporate hiring amid 'uncertain' economy - Beth Galetti, Amazon's Senior Vice President of People Experience and Technology, told employees in a letter: "With the economy in an uncertain place and in light of how many people we have hired in the last few years, Andy and S-team decided this week to pause on new incremental hires in our corporate workforce. We had already done so in a few of our businesses in recent weeks and have added our other businesses to this approach. We anticipate keeping this pause in place for the next few months, and will continue to monitor what we're seeing in the economy and the business to adjust as we think makes sense. In general, depending on the business or area of the company, we will hire backfills to replace employees who move on to new opportunities, and there are some targeted places where we will continue to hire people incrementally. We're facing an unusual macro-economic environment, and want to balance our hiring and investments with being thoughtful about this economy. This is not the first time that we've faced uncertain and challenging economies in our past. While we have had several years where we've expanded our headcount broadly, there have also been several years where we've tightened our belt and were more streamlined in how many people we added. With fewer people to hire this moment, this should give each team an opportunity to further prioritize what matters most to customers and the business, and to be more productive. We still intend to hire a meaningful number of people in 2023, and remain excited about our significant investments in our larger businesses, as well as newer initiatives like Prime Video, Alexa, Grocery, Kuiper, Zoox, and Healthcare."

12:19 EDT Canadian Natural increases dividend 13% to C$0.85 per share - Canadian Natural Resources announces that its board of directors has approved a 13% increase to its quarterly dividend on its common shares to C$0.85 per common share. The dividend will be payable on January 5, 2023 to shareholders of record at the close of business on December 16, 2022. "Canadian Natural's growing and sustainable dividend demonstrates the confidence that the board of directors has in the sustainability of our business model, the strength of our balance sheet and the company's diverse, long life low decline asset base. This increase represents the continuation of the company's leading track record of 23 consecutive years of dividend increases, with a compound annual growth rate of approximately 21% over that period of time," the company stated.

12:08 EDT Lyft: No change to Q3 revenue, margin, adjusted EBITDA guidance - Lyft confirmed there have been no changes to its previously issued guidance regarding: its third quarter 2022 revenues, Contribution Margin and Adjusted EBITDA, and its 2024 financial targets for $1 billion in Adjusted EBITDA with more than $700 million in free cash flow. These targets were issued during the Company's second quarter 2022 earnings conference call on August 4, 2022. The announced reduction in force is a proactive step to ensure the Company is set up to accelerate execution and deliver strong business results in Q4 of 2022 and in 2023. As previously announced, the Company is scheduled to report its third quarter 2022 financial results on Monday, November 7, 2022.

12:06 EDT Icahn confirms holding 8.5% stake in Crown Holdings - Icahn Enterprises (IEP) and Carl Icahn disclosed in a regulatory filing that the reporting persons may be deemed to be the beneficial owner, in the aggregate, of 10,201,273 shares of the common stock of Crown Holdings (CCK), representing an 8.5% stake. Icahn and his associated entities acquired their positions in the shares of common stock "in the belief that they were undervalued and represented an attractive investment opportunity." The reporting persons, among other things, intend to have discussions with representatives of the the company's management and board of directors relating to a variety of matters that they believe will increase shareholder value, including "operational, financial, corporate governance, management, capitalization, accounting, strategic direction, and share performance matters," the filing stated. The Wall Street Journal previously reported that Carl Icahn has accumulated more than an 8% stake in Crown Holdings and wants the company to divest or spin-off noncore assets to focus on the beverage can business.

12:00 EDT Altice USA falls -25.9% - Altice USA is down -25.9%, or -$1.62 to $4.64.

12:00 EDT Lincoln National falls -31.1% - Lincoln National is down -31.1%, or -$16.22 to $35.88.

12:00 EDT Greenhill & Co. rises 23.6% - Greenhill & Co. is up 23.6%, or $1.73 to $9.05.

11:23 EDT Turkcell trading halted, news pending

11:17 EDT LiveOne sets December 22 as record date for PodcastOne stock dividend - LiveOne announced that it has fixed December 22 as the record date to determine LiveOne's shareholders eligible to receive its planned special dividend of between 5% and 10% of PodcastOne's common stock in aggregate as part of its intention to spin-out PodcastOne as a separate public company. "Other criteria to determine LiveOne's shareholders eligible for the special dividend shall be determined and announced by LiveOne at a later date. In July 2022, LiveOne announced that PodcastOne closed a $8.1M financing at a post-money valuation of $68M as part of its intention to spin-out PodcastOne as a separate public company and dividend of a portion of its common equity to 15K+ LiveOne shareholders. LiveOne expects to file a Registration Statement on Form S-1 with respect to spin-out with the U.S. Securities and Exchange Commission by December 15, 2022, and expects to complete the spin-out by the end of its fiscal year ending March 31, 2023. The planned spin-out, amount of the special dividend and LiveOne's shareholders dividend eligibility shall be subject to obtaining applicable approvals and compliance with applicable rules and regulations and public market trading and listing requirements," the company stated.

11:04 EDT Fox Corp. partners with FreeWheel for OneFOX inventory - Fox Corporation (FOX) announced that it has selected FreeWheel (CMCSA) as a partner to enable its OneFOX video inventory across the company's entertainment, sports, streaming and news portfolio. With this agreement, FreeWheel will work with FOX to holistically manage direct sold advertising campaigns across premium content from the company's leading brands, which includes FOX News Media, FOX Sports, FOX Entertainment, and Tubi, the company's leading, free ad-supported streaming service. Additionally, the agreement allows both parties to bring forth new opportunities addressing current industry needs, including: Unified video inventory, ease of management for campaigns running across Fox's portfolio; Additional data and insights capabilities that are available by unifying execution across this portfolio; Working smarter to find target audiences.

10:40 EDT Kushner calls Veris Residential letter 'uninformed', 'disingenuous' - Kushner, one of the largest shareholders of Veris Residential, sent a response to Veris' Board of Directors following their unanimous rejection of Kushner's proposals to the Company: The letter read, " I received your letter which I found to be uninformed at best and disingenuous at worst. Kushner's bid is fully capitalized and committed, which Kushner is happy to substantiate and disclose to the Board if the Board is actually interested in engaging with us. Lip service does not qualify as engagement. This leadership team has no clear long term plan to maximize the value of the portfolio, nor are they the right team to execute. Veris mischaracterizes the prior experience between our two organizations. Veris Board Members have consistently misled Kushner which has further eroded our confidence in current leadership. We made very clear to Board Members we had no interest in acquiring Harborside on its own and were instead prepared to acquire the company at a substantially higher price than today. After being misled for a month, we withdrew an offer for Harborside we were told by the Board to make, left with the unmistakable impression the Board doesn't know what they're doing. Veris rejects external management out of hand because of broad strokes analysis of "externally managed" vs "internally managed". But this completely mischaracterizes the context including the bespoke proposal we've made. Most internally managed REITs are many multiples the size of Veris. Most externally managed REITs are poorly governed fee machines. Our proposal specifically excludes current fee streams, contributes our substantial organization at cost, and calls for a fully independent Board to avoid conflicts. Kushner doesn't engage in third party management for many reasons, and as a substantial owner of the company would be fully aligned with shareholders to maximize the value of the assets. We're glad to see Veris recognize their grossly high G&A load but blaming it on the past and at the same time claiming it's in line with peers is laughable. We will be making our proposal public since this Board and management team are more focused on enriching themselves than shareholders. With respect to performance, the proof is in the pudding. We've distributed hundreds of millions of dollars to our partners over the past 2 years and Veris has distributed zero. The market clearly believes in Kushner more than Veris' management team given recent stock performance. Veris announced the effective completion of their "strategic transformation" and the only people who bought the stock were insiders in receipt of Kushner's overtures. Kushner announced their proposals to the public and the market drove the stock price to levels 50% above last month's all time lows."

10:33 EDT CVRx announces launch of Barostim NEO2 IPG - CVRx annouced its launch of the new Barostim NEO2 IPG. "The second-generation device reduces the size of the IPG by 10% and extends battery life by 20%, reducing the frequency of device replacements for patients and their providers," the company stated. "The new Barostim NEO2 is another leap forward in improving the patient and provider experience with Barostim Therapy. These upgrades enable improved longevity using a smaller footprint and allow physicians to implant the device more easily than ever before," added Nadim Yared, President and CEO of CVRx.

10:31 EDT Nikola to reduce headcount by 7% this month

10:20 EDT Huadi International Group Co trading resumes

10:18 EDT Nikola: Q4, FY23 deliveries to be below expectations - The company did not provide a BEV delivery target for 2023. Comments taken from Q3 earnings conference call.

10:15 EDT Huadi International Group Co trading halted, volatility trading pause

10:12 EDT Nikola says won't meet truck delivery guidance for 2022 - Nikola CFO Kim Brady said on the company's earnings call that battery electric vehicle deliveries in 2022 will fall short of its 300 target. Brady also said that customers are reluctant to invest in charging infrastructure.

10:08 EDT SLNA Stock trading resumes

10:04 EDT ArcelorMittal invests $25M in TerraPower - ArcelorMittal announces it has invested $25 million in nuclear innovation company TerraPower through its XCarb Innovation Fund. The investment is part of an $830 million equity raise TerraPower has concluded, which is the largest private raise among advanced nuclear companies. TerraPower, which was founded by Bill Gates in 2008, entered the nuclear energy arena because the company's founders saw clean energy as the pathway to lift billions out of poverty. It has spent the last decade investing in and developing ground-breaking nuclear technologies. Its flagship technology is Natrium, which features a cost-competitive sodium fast reactor combined with a molten salt energy storage system. This combination will provide clean, flexible energy and integrate seamlessly into power grids with high penetrations of renewables. TerraPower is experiencing significant growth, and is currently building its first Natrium reactor, a TerraPower and GE Hitachi technology, as part of the U.S. Department of Energy's Advanced Reactor Demonstration Program. The facility, being constructed near the site of a retiring coal plant in Kemmerer, Wyoming, will feature a 345 MWe sodium fast reactor alongside an energy storage system that can boost output to 500 MWe during peak demand. Large scale, first-of-a-kind, energy generation projects like the Natrium project take years to come to fruition, and TerraPower is targeting an in-service date for the project within this decade.

10:04 EDT Vuzix leases manufacturing space to support expansion of waveguide production - Vuzix Corporation announces that the Company has signed a new lease for floor space in a building adjacent to its West Henrietta headquarters for the express purpose of expanding its waveguide production capacity. The lease is for partial occupancy of the building with an option to lease the entire building as needed for future phase expansion. This action is expected to increase the Company's annual production capacity to well over one million units during the first half of 2023. "The optical, weight and power advantages offered by Vuzix waveguides are well appreciated by our partners in enterprise, defense, consumer and other markets. With the growing demand for custom configured waveguides emerging for us, it is an opportune time for Vuzix to be ramping its waveguide production capacity," said Paul Travers, President and CEO of Vuzix. "All Vuzix OEM solutions are designed and manufactured in-house here in New York State, protected by a deep IP portfolio, and supported by facilities equipped to supply at scale and at a cost competitive price for key customers."

10:02 EDT Ardelyx presents new data analyses at Kidney Week 2022 on XPHOZAH - Ardelyx announced that new analyses of data from its three Phase 3 trials supporting the clinical utility of XPHOZAH will be presented at the American Society of Nephrology, ASN, Kidney Week 2022, taking place in Orlando, Florida from November 3-6, 2022. "These data continue to support the benefit that novel-mechanism XPHOZAH could have for patients on dialysis with hyperphosphatemia," said David Rosenbaum, Ph.D., chief development officer for Ardelyx. "Notably, early response to XPHOZAH was found to be predictive of continued response throughout the treatment period. This information could help guide treatment decisions that maximize the potential therapeutic benefit of XPHOZAH for these patients. With over 1,100 patients treated with XPHOZAH in clinical studies in the U.S. as well as clinical data generated by our partner Kyowa Kirin in Japan, we believe the impact that this first-in-class treatment could have for CKD patients on dialysis is clear."

10:01 EDT Microsoft, Raytheon Technologies expand collaboration - Raytheon Technologies (RTX) is deepening its collaboration with Microsoft (MSFT) to equip the aerospace and defense company's employees with cloud-based tools, technologies, and platforms to enhance collaboration, optimize operations and unlock intelligent insights that drive greater value for customers. The effort includes co-development of capabilities, as well as Raytheon Technologies' use of existing or modified versions of popular Microsoft solutions such as Microsoft Teams. It is part of the company's strategy to optimize operations and give employees access to standardized digital tools globally.

10:00 EDT Intrepid Potash falls -20.2% - Intrepid Potash is down -20.2%, or -$8.69 to $34.38.

10:00 EDT Altice USA falls -33.9% - Altice USA is down -33.9%, or -$2.12 to $4.14.

10:00 EDT Tecnoglass rises 17.1% - Tecnoglass is up 17.1%, or $3.40 to $23.30.

09:59 EDT Clever Leaves partners with Anden Naturals to bring cannabis to Peru - Clever Leaves Holdings announced that its partner, Peruvian medicinal cannabis company Anden Naturals, has obtained the sanitary registration for the finished product, "Andenol 50," a 5% THC dominant oral solution produced by Clever Leaves in Colombia and sold under the Anden Naturals brand in Peru. Andenol 50, is Anden Naturals' first THC dominant product to obtain sanitary registration for its commercialization as a finished product and is considered to be a "phytotherapeutic" product, by the Peruvian health authority and indicating passage of all quality inspections. Anden Naturals manufactures and markets medicinal cannabis products in Peru through magistral formulations as well as finished products imported from other countries. The company distributes medical cannabis products through its own pharmacies in the country. Obtaining this sanitary registration of a THC dominant finished product reflects both the unmatched quality of the medical cannabis cultivated by Clever Leaves and Clever Leaves' rigorous product development processes. The initial shipment of 1,000 units is set for Q1 of 2023 and the potential market is expected to be 30,000 registered patients, according to data as of August 2022.

09:55 EDT Verb Technology, Pittsburgh Pirates announce video multiyear deal - VERB Technology Company announced that the Company has entered into a multi-year partnership with its first Major League Baseball team, the Pennsylvania-based Pittsburgh Pirates to deploy VERB's suite of sales enablement solutions in driving ticket and merchandise sales and engaging with Pirates fans through interactive, shoppable digital content.

09:51 EDT Greenpro Capital's incubatee company Celmonze plans to go public - Greenpro Capital Corp. announced that its incubation company, Celmonze plans to go public to the U.S. Capital Market in year 2023. Celmonze focuses on skincare and beauty products businesses in Malaysia and Singapore since year 2000. Celmonze International Laboratories now comprises of five research labs located across Europe and North America, with its headquarters based in Paris, France. Celmonze now has more than 80 outlets to serve the market and will continuously growing to a targeted 200 outlets across the ASEAN region.

09:50 EDT Kellogg expects bottlenecks, shortages to last through Q4, says CEO

09:49 EDT Precision BioSciences: Abstract on Azer-cel accepted for presentation at ASH - Precision BioSciences announced that an abstract on the effective cell dose and functional attributes of the company's lead CD19 candidate, Azercabtagene Zapreleucel was accepted for poster presentation at the 64th American Society of Hematology Annual Meeting and Exposition, being held December 10-13, 2022 in New Orleans, Louisiana. Precision is currently evaluating azer-cel in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory non-Hodgkin lymphoma who relapsed following treatment with an autologous CAR T. "We look forward to seeing this data presented at the ASH meeting and highlighting the differentiated product cellular attributes including product composition and cell doses that contribute to optimized efficacy and safety of azer-cel. This is the first analysis of an allogeneic CD19 CAR T product composition to demonstrate that strategies to maximize naive cell phenotype may lead to improved safety and efficacy of an allogenic CAR T therapy," said Alan List, M.D., Chief Medical Officer of Precision BioSciences.

09:47 EDT Advanced Drainage falls -21.9% - Advanced Drainage is down -21.9%, or -$24.85 to $88.60.

09:47 EDT Lincoln National falls -25.3% - Lincoln National is down -25.3%, or -$13.19 to $38.91.

09:47 EDT Ball Corp. rises 8.3% - Ball Corp. is up 8.3%, or $3.95 to $51.80.

09:45 EDT BioLargo adds Linda Park, Christina Bray to board of directors - BioLargo announced it has added two new board members to its team: Linda Park and Christina Bray. Linda Park is a trusted executive and legal professional with a proven track record of supporting and advising public companies. Christina Bray is a senior finance specialist, entrepreneur, and renewables specialist, and currently serves as the CEO and founder of Bluedot Energies.Concurrently, board members John Runyan and Kent Roberts II have retired from their positions on the Board of Directors where they served faithfully for over a decade. Both will remain as formal Advisors to the Board of Directors as their time permits.

09:44 EDT Merus trading resumes

09:42 EDT IDBA Stock trading resumes

09:41 EDT Kellogg sees gross profit margin up in Q4, but not as much as expected - Comments taken from Q3 earnings conference call.

09:39 EDT 10x Genomics trading resumes

09:37 EDT Altice USA trading halted, volatility trading pause

09:36 EDT Electrovaya announces C$14.8M private placement - Electrovaya has entered into securities purchase agreements with existing institutional investors, new institutional investors and insiders for a private placement of the Company's common shares and warrants to purchase common shares for aggregate gross proceeds to the Company of approximately C$14.8 million. The Company agreed with purchasers to use its best efforts to complete a listing of its Common Shares on the Nasdaq Capital Market by April 30, 2023. Pursuant to the Private Placement, the Company will issue 17,543,402 Common Shares and Warrants exercisable to purchase up to 8,771,700 Common Shares at a purchase price of C$0.8461 per Common Share and associated Warrant. Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of C$1.06 per Common Share, subject to adjustment in accordance with the terms and conditions of the Warrants, at any time prior to the three-year anniversary of the closing date of the Private Placement. In addition, if the Common Shares are not listed on the Nasdaq Capital Market by April 30, 2023, the exercise price of the Warrants by such date will be adjusted to C$0.94 per Common Share, subject to adjustment in accordance with the terms and conditions of the Warrants. The Private Placement is anticipated to close on or about November 7, 2022, and is subject to the satisfaction of certain customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals, including the approval of the Toronto Stock Exchange. Craig-Hallum Capital Group LLC is acting as exclusive placement agent for the Private Placement in the United States.

09:35 EDT Uber's Drizly announces new brand direction - Drizly, an Uber Company, announced its new brand direction. The company said: "Drizly is signaling its expansion from an on-demand-only player with delivery in 'under 60 minutes,' to a tailored e-commerce shopping destination focused on helping customers find the best drink for the moment, whether they need it now or later. This transition is further supported by the broadening types of moments and occasions that Drizly has observed consumers turning to the platform for, including sending gifts. With gifting experiencing sustained momentum on Drizly over the past few years, gift order share has scaled over 100 percent from 2019 to 2022 to date. As part of this brand evolution, Drizly is rolling out a redesigned product experience, with ongoing updates slated in the coming months to better serve all of its customer's life moments."

09:34 EDT Merus trading halted, volatility trading pause

09:32 EDT IDBA Stock trading halted, volatility trading pause

09:32 EDT Cassava files lawsuit against perpetrators of 'short and distort' campaign - Cassava Sciences announced that it has filed a lawsuit in federal court against certain individuals who executed a "short and distort" campaign against the Company. The 150+ page complaint alleges that the Defendants' disinformation campaign caused a precipitous decline in Cassava Sciences' stock price, a multi-billion dollar decline in its market capitalization, and delayed the Company's work in developing a treatment for Alzheimer's disease. The lawsuit alleges: "Defendants placed personal enrichment over science, over the health of patients, and over the truth. Defendants saw an opportunity to manipulate a stock price and financially benefit from their 'short positions' by defaming a company developing a drug for people with Alzheimer's disease, a condition that afflicts millions of people. Defendants seized that opportunity and, while enriching themselves, caused irreparable harm to the company, its attempts to find a treatment for the disease, and patients waiting for that treatment." The complaint identifies over 1,000 false and defamatory statements made by the Defendants in submissions to the U.S. Food and Drug Administration as well as "reports" and presentations that Defendants published online or on social media.

09:30 EDT OraSure receives general clearance for its ORAcollect Dx device - OraSure Technologies announced that the Company received U.S. FDA clearance for its ORAcollect*Dx saliva collection device for OTC use. The device had been previously cleared for prescription use by the FDA. ORAcollect*Dx joins the Oragene*Dx product line which previously received FDA general clearance for prescription and OTC use. This new designation now allows ORAcollect*Dx devices to be used by OraSure's commercial partners and legally marketed with their therapeutics or devices in conjunction with their product's intended use. OraSure received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency in individuals who may be at risk for alpha-1. Alpha-1 raises patients' risks for lung disorders and it is estimated that about 3% of COPD patients have alpha-1. Beginning in Q2 2023, Grifols will offer free AlphaID At Home Genetic Health Risk Service, supporting alpha-1 screening, that utilize the ORAcollect*Dx device to help identify individuals at risk. "This clearance represents a major milestone for OraSure as we work in conjunction with our commercial partners to increase access to healthcare," said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. "With the movement toward precision medicine, we increasingly see the need for genetic testing supporting FDA approved therapeutics as drugs become more specialized for targeted patient populations. This expanded designation now allows us to better support our customers and expands the potential for future indications with the ORAcollect(R)*Dx device."

09:30 EDT Vyant Bio sells vivoPharm subsidiary to Reaction for $5.5M - Reaction Biology and Vyant Bio announced that the companies have closed on a definitive agreement for Reaction to acquire Vyant Bio's subsidiary vivoPharm LLC, located in Hershey, Pennsylvania. Reaction will retain U.S. personnel from the acquired operations to establish its Hershey, Pennsylvania presence. The purchase price for the transaction is $5.5M in an upfront cash payment. Vyant Bio expects to net approximately $4.4M in cash after tax and transaction related expenses, as well as incur $0.6M in exit costs associated with this transaction. "This transaction provides non-dilutive capital and enables Vyant Bio to further concentrate our efforts to more rapidly advance our therapeutic pipeline in genetic CNS disorders," said Jay Roberts, CEO.

09:29 EDT In8bio announces 'positive' early data from the ongoing INB-100 Phase 1 trial - IN8bio announced "positive" early data from the ongoing Phase 1 trial evaluating INB-100, an allogeneic gamma-delta T cell therapy, in patients with high-risk acute myeloid leukemia, or AML, undergoing haploidentical hematopoietic stem cell transplant have been selected for a poster presentation at the 64th American Society of Hematology, or ASH, Annual Meeting and Exposition taking place December 10-13. The abstract highlights data from Cohort 1 of the ongoing Phase 1 clinical trial of INB-100 in patients with high-risk AML undergoing HSCT. Three patients have at least 12 months of follow-up, and all remain in morphological complete remission , or CR; two patients have remained progression-free for more than two years and a third for more than one year post-transplant at the time of abstract submission. Immune system reconstitution through the first 100 days post-treatment demonstrates continued normal function, including observed elevations in T cells, B cells, and gamma-delta T cells. No DLTs or greater than grade 3 events of acute or chronic graft versus host disease, cytokine release syndrome, or immune effector cell neurotoxicity syndrome have been observed. The most common adverse events were constipation, cytomegalovirus reactivation, emesis, fatigue, and hypomagnesaemia, the majority of which were Grade 1/2. Additional updated data will be presented during the poster session at ASH. Trishna Goswami, M.D., Chief Medical Officer of IN8bio, said: "The patients with high-risk AML undergoing HSCT in Cohort 1 continue to demonstrate encouraging signs of long-term durable responses after a single dose with INB-100. These early signs of long-term durability and progression-free survival demonstrate the potential of INB-100 as a new treatment option in this patient population. Importantly, the safety profile on INB-100 continues to be manageable, and we have not seen dose-limiting toxicities to date, which is encouraging. These data suggest that treatment with a one-time allogeneic gamma-delta T cell therapy has the potential to disrupt the treatment paradigm for AML. We look forward to sharing updated data at ASH and additional data at future peer-reviewed conferences."

09:27 EDT Affimed, Artiva announce partnership to advance therapy of AFM13, AB-101 - Affimed announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimed's Innate Cell Engager, ICE, AFM13 and Artiva's cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101. This clinical agreement follows the parties' existing two-year preclinical collaboration to assess combining elements of the companies' respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies. As part of the collaboration, the companies evaluated the combination of AFM13 and AB-101 in various preclinical models and generated data that supports development of a co-administered combination therapy. The Affimed-Artiva partnership aims to expedite further development of the combination therapy in CD30-positive lymphoma patients who have exhausted other treatment options. The companies plan to file an IND for the program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023. Under the terms of the agreement, Affimed and Artiva will pursue the development of the AFM13/AB-101 combination treatment in the United States on a co-exclusive basis. Affimed will lead regulatory activities through Phase 2 and any confirmatory studies. Affimed will be responsible for funding clinical study costs through Phase 2, while Artiva will be responsible for the costs of supplying AB-101 and IL-2 for such studies. If accelerated approval is obtained, the companies will share confirmatory study costs on a 50/50 basis.

09:25 EDT Apellis to present long-term data on efficacy, safety profile of EMPAVELI - Apellis Pharmaceuticals announced that results from the long-term extension study of EMPAVELI in adults with paroxysmal nocturnal hemoglobinuria, PNH, will be presented at the American Society of Hematology, ASH, Annual Meeting being held Dec. 10-13 in New Orleans, Louisiana. The data show that EMPAVELI, the first and only targeted C3 therapy, demonstrated robust and sustained improvements in key markers of disease across a broad population of PNH patients for up to two years. The new results reinforce the positive efficacy and safety of EMPAVELI in both treatment-naive patients and patients who had previously been treated with eculizumab, a C5 inhibitor, across all five prior PNH clinical studies. After being treated with EMPAVELI for up to two years, mean hemoglobin was sustained at near-normal levels at 11.6 g/dl, 83% of patients were transfusion free, and 73% of patients had normalized levels of lactate dehydrogenase. Long-term safety data were consistent with previous clinical study results, with no thrombotic events or meningitis infections reported. The most common adverse events were hemolysis and injection site reactions.

09:24 EDT Orchard Therapeutics announces neurocognitive data from OTL-201 study - Orchard Therapeutics announced early clinical findings from its ongoing proof-of-concept study of investigational OTL-201 in MPS-IIIA will be featured in an oral presentation at the 64th American Society of Hematology Annual Meeting & Exposition, taking place December 10-13, 2022, in New Orleans. The oral presentation at ASH 2022 will showcase the first neurocognitive data for all patients and extend upon previously presented biochemical results, with a median follow-up of 1.5 years. Orchard is planning to host a virtual KOL investor webcast on Monday, December 12, 2022, at 5:00 p.m. EST to review the data presented at the meeting. A live webcast will be available under "Events" in the Investors & Media section of the company's website at www.orchard-tx.com and a replay of the webcast will be archived following the event. Five patients with MPS-IIIA, aged 6 to 24 months, were treated with OTL-201 as part of this ongoing proof-of-concept trial, sponsored by The University of Manchester, conducted at Royal Manchester Children's Hospital, and funded by Orchard Therapeutics. Primary study objectives include safety, tolerability and peripheral expression of SGSH activity in total leukocytes at 12 months. Secondary study objectives include overall survival and neurocognition as measured by the Bayley Scales of Infant and Toddler Development. Patients will be followed for a minimum of three years.

09:23 EDT Diana Shipping announces delivery of Ultramax dry bulk vessel m/v DIS Phoenix - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has taken delivery of the m/v DSI Phoenix, a 2017 built Ultramax dry bulk vessel of 60,456 dwt. The vessel is one of nine modern Ultramax dry bulk vessels that the Company entered into an agreement to purchase in August 2022. Including the newly delivered m/v DSI Phoenix, Diana Shipping Inc.'s fleet currently consists of 37 dry bulk vessels. The Company also expects to take delivery of 6 Ultramax dry bulk vessels in the fourth quarter of 2022. As of today, the combined carrying capacity of our fleet, excluding the 6 Ultramax dry bulk vessels not yet delivered, is approximately 4.6 million dwt with a weighted average age of 10.29 years.

09:22 EDT Magenta Therapeutics to present MGTA-117 data at 2022 ASH meeting - Magenta Therapeutics announced that it will make three presentations relating to its ongoing clinical trials at the 2022 American Society of Hematology Annual Meeting, to be held in New Orleans from December 10-13, 2022 and virtually. In addition, an academic collaborator will present data from a preclinical program from Magenta's research platform. "We have made significant progress in the MGTA-117 Phase 1/2 clinical trial and look forward to presenting clinical evidence at ASH that we believe supports proof-of-mechanism for MGTA-117. We are also very encouraged by the predictive value of our MGTA-117 preclinical modeling which has closely matched our pharmacokinetics and pharmacodynamics clinical experience in the early cohorts of the ongoing study. We expect these results will collectively inform the continued development of MGTA-117, our most advanced targeted antibody-drug conjugate, to enable more patients to benefit from stem cell transplant and gene therapies," said Jason Gardner, D.Phil., President and CEO, Magenta Therapeutics.

09:22 EDT Rocket Lab delivers final solar panels to Maxar for lunar space station - Rocket Lab (RKLB) has delivered the final solar panels to Maxar (MAXR) that will fly on the Power and Propulsion Element for NASA's Gateway lunar space station. SolAero Technologies Inc, a space solar power provider acquired by Rocket Lab, was awarded the contract in 2019 from Maxar to design and manufacture the solar panels that will supply nearly 70 kilowatts of electrical power to Gateway, an essential element of NASA's Artemis missions that will land the first woman and first person of color on the surface of the Moon.

09:21 EDT Nikola appoints Michael Lohscheller as CEO, effective November 2 - In a regulatory filing, Nikola announced that on November 2, the board of directors of the company appointed Michael Lohscheller CEO in connection with Mark Russell's retirement from that position, in each case effective November 3, as opposed to the previously-announced effective date of January 1, 2023. Russell continues to serve as a member of the Board.

09:20 EDT Centessa to present additional 18-months data from OLE of Phase 2a study - Centessa Pharmaceuticals announced that new data from an additional 18-months of continued treatment with SerpinPC from the open-label extension of AP-0101, a Phase 2a study of SerpinPC for the treatment of hemophilia, has been accepted for oral presentation at the 64th American Society of Hematology Annual Meeting, to be held in New Orleans, LA, from December 10 - 13, 2022. The ASH presentation will include efficacy, safety, and tolerability data from 18-months of continued treatment with a subcutaneous injection of SerpinPC, a novel inhibitor of activated protein C, at a flat dose of 60 mg once every 4 weeks for 48 weeks, followed by 1.2 mg/kg once every 2 weeks for 24 weeks, in subjects with hemophilia. The abstract accepted for oral presentation is detailed below and included in the online meeting program on the ASH Annual Meeting website. AP-0101 is a first-in-human open-label multicenter study to investigate the safety, tolerability, pharmacokinetics and efficacy of subcutaneous doses of SerpinPC in male participants with severe hemophilia. The Company previously announced the results for Parts 1 and 2 (six-month repeat dose) on September 9, 2021. Part 1 was a Single Ascending Dose Study completed in 15 healthy male subjects and in 12 male persons with hemophilia. All 12 PwH in Part 1b chose to participate in Part 2. Part 2 enrolled 23 male PwH who were not on replacement factor prophylaxis to receive SerpinPC at 0.3, 0.6 or 1.2 mg/kg, administered as a subcutaneous injection once every 4 weeks over a 24-week period. For the OLE, in Part 3, subjects who completed Part 2 received a flat dose of 60 mg of SerpinPC administered as a subcutaneous injection once every 4 weeks for 48 weeks. In Part 4, subjects who completed Part 3 received 1.2 mg/kg of SerpinPC administered as a subcutaneous injection once every 2 weeks for 24 weeks. The abstract to be presented at ASH will share results from the OLE with a follow-up of 48 and 24 weeks, respectively.

09:20 EDT Beam Therapeutics to present ESCAPE approach data at ASH - Beam Therapeutics announced that new data supporting the advancement of its Engineered Stem Cell Antibody Paired Evasion conditioning approach will be presented during poster sessions at the 64th Annual American Society of Hematology Annual Meeting and Exposition. The meeting is being held December 10-13, 2022, in New Orleans. Beam is advancing ESCAPE as part of its long-term strategy to support broad accessibility of base editing treatments for patients with sickle cell disease and other hematologic diseases. The data to be presented at ASH expand upon data presented earlier this year for its ESCAPE-1 approach, which consists of multiplex base edited HSCs that include a therapeutic edit for SCD at the HGB1/2 gene designed to enable upregulation of fetal hemoglobin and an additional simultaneous edit at CD117. Findings showed that the edit-antibody pair targeting CD117, an optimal conditioning target for eliminating HSCs, led edited HSCs to function normally but escape the binding of the conditioning antibody. In addition, Beam will present work on ESCAPE-2, in which the company leveraged its initial ESCAPE work to screen guides that were compatible, in a multiplex-edited HSC, with a next-generation adenine base editor that could install the therapeutic HbG-Makassar edit. "Improving conditioning regimens for patients ahead of autologous transplant is a key focus for Beam as part of Wave 2 of our long-term strategy to bring best-in-class base editing treatments to people with SCD," said Giuseppe Ciaramella, Ph.D., president and chief scientific officer of Beam.

09:16 EDT Immersion renews multi-year license with with Nippon Seiki - Immersion announced that it renewed a multi-year license to Immersion's technology with Nippon Seiki a global supplier of control panels for home, office and factory appliances, for use in Nippon Seiki's line of printer and copier products, and has expanded its license with Immersion to cover Nippon Seiki's automotive products. "We are increasingly seeing more new car models adopting haptics across various interfaces throughout the cabin," said Nobumitsu Shimada, Representative Director, Japan and VP, APAC, Immersion. "We are pleased that Nippon Seiki has renewed its license with us and expanded its license of our patented technology to the automotive market. We are proud to count Nippon Seiki among our licensees in the automotive market."

09:16 EDT Tradeweb Markets reports total trading volume for October of $21.3T - Tradeweb Markets reported total trading volume for October of $21.3T. Average daily volume for the month was $1.05T, a decrease of 16.5% year-over-year.

09:15 EDT Roku CFO Steve Louden to step down in summer of 2023 - In an 8-K filing last night, Roku announced: "On October 31, 2022, Steve Louden, CFO, advised us that after helping us recruit and transition his role to a successor he plans to leave the company. We expect this transition to take place sometime in 2023, and will commence an executive search to identify Mr. Louden's successor."

09:14 EDT Distribution Solutions increases share buyback program to $12.5M - The board of Distribution Solutions authorized an increase of the existing share buy-back program from $7.5M to $12.5M. During the quarter, the company repurchased approximately 54,000 shares of its common stock for an aggregate price of $1.9M which leaves $7.6M available under its expanded authorized share repurchase plan.

09:13 EDT CleanSpark reports 532 bitcoin mined in October - CleanSpark released its unaudited bitcoin mining and operations update for the calendar year-to-date ending October 31, 2022. "I'm excited to announce that phase two of our immersion-cooled mining campus in Norcross is now officially complete and hashing. The progress there has translated into another record-breaking month for us, mining a total of 532 bitcoin. And we've now seen a 20% increase in our hashrate two months in a row. As I've said many times before, these successes are made possible by the hard work of our teams who are absolutely dedicated to ensuring CleanSpark maintains its position as a top publicly traded mining company in North America," said Zach Bradford, Chief Executive Officer. Bitcoin Mining & Operations Update: Bitcoin mined in October: 532, up 19% from September 2022; Calendar year-to-date bitcoin mined: 3,622; Total BTC holdings as of October 31: 290; Total BTC converted for operations and growth in October: 836; Currently deployed fleet of about 54,000 latest-generation bitcoin miners with a hashrate of 5.1 EH/s as of October 31, up 23% from September 2022. The Company funded growth and operations through the sale of 836 bitcoins in October 2022 at an average of approximately $19,340 per BTC. Sales of BTC equated to proceeds of approximately $16.1 million. October daily BTC mined reached a high of 19.2.

09:11 EDT SeaStar Medical announces safety finding from study of SCD in children - SeaStar Medical Holding announced positive interim data in a poster presentation at the American Society of Nephrology Kidney Week 2022 taking place November 3-6, 2022 in Orlando, FL. The poster titled, Multi-Center Study to Assess the Safety of a Selective Cytopheretic Device for Treatment of Immunomodulatory Dysregulation due to AKI in Children greater than or equal to10 and less than or equal to20 kg: Report From the First 4 Patients, will be presented by Stuart Goldstein, MD, Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital as part of the session "AKI: Biomarkers, Risk Factors, Treatments, Outcomes" on Thursday, November 3, 2022 from 10:00 AM - 12:00 PM ET. The presented poster highlights preliminary findings from the Company's ongoing open-label clinical trial being conducted at five pediatric hospitals across the U.S. evaluating the SCD for the treatment of Immunomodulatory Dysregulation due to severe AKI. The study is evaluating children that weigh between greater than or equal to10 and less than or equal to 20kg, have a clinical diagnosis of AKI requiring CKRT and at least one non-renal organ failure. With these subjects the SCD was integrated post CKRT membrane, changed daily, and circuit ionized calcium maintained less than0.4 mmol/L. Subjects received SCD treatment for up to 10 days or CKRT discontinuation, whichever came first. Participants are followed through Day 60 post SCD initiation for mortality and dialysis dependence. Under the current study, six subjects have been treated with the SCD. Four subjects developed AKI in the presence of shock, and the other two subjects developed AKI in the setting of STEC Hemolytic Uremic Syndrome. All subjects ended SCD therapy before Day 10. Five of the subjects transitioned off CKRT for improvement in clinical status; Family chose to withdraw all care for subject on ECMO after 136 hours of SCD. Of the 660 hours of SCD treatment given, circuit iCa levels were less than or equal to0.4 mmol/L 95% of the time. Of the subjects that reached Day 60, 5 were still inpatient and dialysis independent and 1 subject deceased after SCD therapy had ended but before ICU discharge. An additional patient was enrolled but did not continue with SCD because their iCa was not in range due to citrate intolerance. To date, no SCD-related serious adverse events have been reported in pediatrics. Approximately 4,000 pediatric patients in the U.S. each year with AKI require CKRT and those patient profiles are associated with high morbidity and mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk of long-term conditions, including chronic kidney disease. The SCD is currently being evaluated by the FDA for a Humanitarian Device Exemption marketing approval for use in children with AKI. The Company expects the FDA to complete a substantive review of its HDE application during the first quarter of 2023, with a potential commercial launch expected in the second quarter of 2023. Dr. Goldstein served as a consultant to SeaStar Medical in the preparation and submission of the HDE application.

09:11 EDT SAB Biotherapeutics presents overview of DiversitAb platform, data - SAB Biotherapeutics announced that the Company presented an overview of its DiversitAb polyclonal platform and data on SAB-176 and SAB-185 showing the benefits of fully-human polyclonal antibodies derived from SAB's Transchromosomic Bovin over plasma derived antibodies from humans, at the 2022 Plasma Product Biotechnology Conference in Limassol, Cyprus, which concluded on Nov. 3. In a presentation titled, "Plasma fractionation and downstream processing of human polyclonal antibodies from the DiversitAb platform," Dr. Bausch presented an overview of SAB's novel immunotherapy platform utilizing a specialized manufacturing process to enable a scalable and reliable production of targeted, higher-potency neutralizing antibody products than has been previously possible.Titled "Phase 2 efficacy and safety of two novel SAB immunotherapies against respiratory disease indications associated with highly mutating viruses," Dr. Bausch's second presentation outlined data on SAB-185 for COVID-19 and SAB-176 for seasonal and pandemic influenza. The data show that SAB-185 and SAB-176 are highly effective against variants of several highly mutating viruses associated with the diseases, a major challenge in currently available treatments for COVID-19 and influenza.

09:10 EDT ironSource announces expansion of partnership with Samsung - ironSource (IS) announced the expansion of its partnership with Samsung (SSNLF), as it launches on mobile devices in the Middle East and North Africa. Aura, ironSource's solution suite for telecom operators and OEMs, is already integrated on Samsung mobile devices in more than 30 markets, including Europe, Russia, South East Asia and India, and ironSource will now be Samsung's sole partner on newly released A-series and M-series mobile devices in over 50 markets across MENA - strengthening Aura's footprint in the region.

09:09 EDT Grifols receives FDA clearance for AlphaID At Home Genetic Health Risk Service - Grifols announced that its AlphaID At Home Genetic Health Risk Service, the first-ever free direct-to-consumer program in the U.S. to screen for genetic risk of alpha1-antitrypsin deficiency, has been cleared by the U.S. FDA.

09:08 EDT MessageMedia integrates into BigCommerce Platform - MessageMedia announced an Early Access Program to its direct integration with BigCommerce (BIG). The new MessageMedia SMS Marketing integration provides tens of thousands of BigCommerce merchants with an easy-to-use, full-featured turnkey messaging solution to better engage customers at key points in the buyer's journey and improve efficiency in the online buying process. MessageMedia is a wholly owned subsidiary of Sinch (CLCMF).

09:06 EDT BYND Cannasoft provides update on patent application for EZ-G device - BYND Cannasoft Enterprises announced that as part of the PCT patent application process for the EZ-G device, an International Searching Authority examiner has provided a preliminary, non-binding opinion that one of the inventions comprising the EZ-G device is novel and inventive. BYND Cannasoft can now accelerate the examination of its present application in some jurisdictions, such as the US and Israel, as part of a PCT-PPH program. Although non-binding, the positive opinion of the ISA examiner provides greater comfort of the patent application proceeding through the examination procedure without objections being raised as to a substantive lack of patentability. The EZ-G device is a unique, patent-pending device that, combined with proprietary software , regulates the flow of low-concentration CBD oils into the soft tissues of the female reproductive system. According to research conducted across the globe, treatment with low-concentration CBD oils can relieve candida, dryness, scars, and many other female health issues. In September, BYND Cannasoft completed its acquisition of Zigi Carmel Initiatives & Investments Ltd., which holds the intellectual property for the patent-pending EZ-G device. At that time, BYND Cannasoft announced plans to pursue the patent and establish a marketing and sales system for the EZ-G device based on B2B and B2C sales.

09:05 EDT Neurocrine presents data on Ingrezza capsule performance - Neurocrine will present data from a study on Ingezza capsules evaluating in vitro dissolution performance of whole intact or crushed capsule contents in 40 mg and 80 mg strength. The data demonstrated that crushing the capsule contents of Ingrezza did not impact the dissolution performance in vitro. Additionally, very rapid and complete drug release was observed in all samples, independent of capsule strength or preparation. Neurocrine Biosciences will also present data on the long-term use of valbenazine for tardive dyskinesia in elderly patients .

09:04 EDT NeuroMetrix announces strategic launch of Quell Fibromyalgia - NeuroMetrix announced the strategic launch of its Quell Fibromyalgia device through the Pathfinder Program. Quell Fibromyalgia is the first and only medical device authorized by the U.S. Food and Drug Administration to help reduce the symptoms of fibromyalgia. The Pathfinder Program is designed to validate and further refine the commercial process for Quell Fibromyalgia in anticipation of a full commercial launch in Q2 of 2023. Pathfinder starts on December 1, 2022 and will be limited to 25 key-opinion leaders in fibromyalgia practice across the United States. The guidance of these key physicians will be significant to the Company's ability to effectively communicate the benefits of Quell to patients and healthcare professionals.

09:04 EDT MFA Financial reports book value $15.31 as of September 30 -

09:02 EDT MFA Financial reports book balue $15.31 as of September 30

09:01 EDT Fat Brands enters development deal to open 80 franchised locations - FAT Brands Inc., parent company of Round Table Pizza, Fatburger, Buffalo's Express and 14 other restaurant concepts, announces a new development deal to open 80 new franchised locations in the state of Texas. In partnership with Brame Holdings LLC, 40 Round Table Pizza restaurants and 40 co-branded Fatburger and Buffalo's Express locations will open over the next 10 years with the first units slated to open in 2023.

08:59 EDT ParkerVision secures patent license agreement with Hisense - ParkerVision announced today that it has successfully resolved its patent infringement litigation against Chinese Hisense International on mutually-agreeable and confidential terms including a license covering certain patents. In conjunction with this agreement, ParkerVision will file a motion to dismiss its patent infringement proceedings against Hisense in the Western District of Texas and Hisense will withdraw from the pending IPR proceedings against ParkerVision. ParkerVision initiated a patent infringement action against Hisense in the Western District of Texas in September 2020, with a second action filed in June 2021. The infringement action related to Hisense's use of WiFi chips in certain of its products. ParkerVision has additional patent infringement actions currently ongoing in the Western District of Texas including cases against Intel, TCL and LG.

08:55 EDT Orbit International reports bookings in excess of $5M in October - Orbit International announced that consolidated bookings for the month of October 2022 were in excess of $5,000,000. Deliveries for some of these orders have already commenced and are expected to continue through the fourth quarter of 2023. Mitchell Binder, President and CEO of Orbit International commented, "We are pleased to report that our consolidated bookings for the month of October were in excess of $5,000,000, representing our strongest booking month of 2022. Our Electronics Group bookings were approximately $3,100,000 and were highlighted by two orders previously announced by our Q-Vio subsidiary. These orders, totaling in excess of $2,350,000, are for displays used on a major U.S. Army program. Our OEG bookings also include approximately $400,000 in orders received by our Simulator Product Solutions subsidiary. Bookings from our Power Group totaling in excess of $1,900,000, were the highest amount received in 2022 and were highlighted by (i) approximately $775,000 for a COTS power supply used for a major armament system; (ii) approximately $300,000 for production units used for oil and gas exploration; and (iii) approximately $325,000 for a follow-on order for COTS power supplies used on a major missile defense system. In addition, we have been working on a significant follow-on order with a customer utilizing our VPX power supply. However, although we expected to receive this award in 2022, it now appears this contract will not be received until at some point in 2023. Despite the strong month of bookings for both our operating groups, in addition to the aforementioned VPX opportunity, as previously reported both our OEG and OPG are experiencing continued delays in the awards of contracts on key programs. Several factors are causing delays on these awards, which are coming from the Department of Defense, including work restrictions related to the pandemic, a shifting of prioritization of certain contract awards from the DoD, funding delays due to increased prices and other timing issues. It should be noted that timing uncertainty in the receipt of contracts from our prime contractors doing business with the U.S government is an inherent factor in our industry. As in the past, although timing remains an uncertainty, we expect these contract awards to eventually be received, although some of these awards that were expected during the current year may be delayed until 2023."

08:52 EDT LYTE by Phunware waving its build fee for November - LYTE by Phunware announced the launch of its "No Build Fee" Black Friday Sale, which will run the entire month of November. During November, the company is waiving its standard $100 flat build fee for any purchase of a pre-built or custom PC. "At LYTE by Phunware, we know the way to a gamer's heart, especially during the holiday season, is through a next-level PC," said Caleb Borgstrom, GM of gaming at LYTE by Phunware. "That is why -- for the entire month of November -- we are making it more affordable than ever to make their holiday wishes come true this season."

08:51 EDT Applied Genetic reminds shareholders to tender their shares - Applied Genetic Technologies President and Chief Executive Officer, Sue Washer, sent the following letter to shareholders: On October 23, 2022, we announced that AGTC entered into a definitive agreement, pursuant to which a portfolio company of Syncona Limited has commenced a tender offer to purchase all of the outstanding shares of common stock of AGTC. Syncona is a leading, well-financed healthcare company focused on founding, building, and funding global leaders in life science, with a successful track record in building ophthalmology gene therapy businesses. pon closing, each stockholder will receive $0.34 per share in cash and a right to receive additional cash payments of up to a maximum of $0.73 per share based on the achievement of certain milestones. The total potential payment represents a premium of up to approximately 344% over the closing share price immediately prior to the transaction announcement and a premium of approximately 268% over the 30-day volume weighted average closing price per share of AGTC's common stock. I am writing today urging you to tender your shares of AGTC common stock in the tender offer. Our board of directors unanimously voted in favor of this acquisition and unanimously recommends that all AGTC stockholders tender their shares. The board believes the transaction represents an attractive offer that is in the best interests of AGTC's stockholders. Should the majority of outstanding shares not be tendered, the Company will have no alternative but to pursue bankruptcy with no certainty of value for stockholders. Our management team and board aggressively pursued alternative opportunities. However, after considering our limited financial resources and the current state of the equity and other funding markets, our board determined that this transaction would maximize stockholder value and enable the continued advancement of our XLRP clinical program, with the potential for additional cash payments to stockholders if the defined milestones are met. We believe this deal delivers the best value to our stockholders. You should have recently received materials relating to the tender offer (by mail or electronic delivery), including (i) a copy of AGTC's Solicitation/Recommendation Statement on Schedule 14D-9, (ii) Syncona's offer to purchase, dated October 26, 2022, which sets forth the terms and conditions of the tender offer, and (iii) instructions as to how to tender your shares of AGTC common stock in the tender offer. We urge you to read these materials carefully. The tender offer is currently scheduled to expire at 5:00 p.m. Eastern Time on Monday, November 28, 2022."

08:50 EDT Navitas Semiconductor, VREMT to open joint R&D Lab - Navitas Semiconductor and VREMT, announced the opening of an advanced, joint R&D power semiconductor laboratory to accelerate EV power-system developments using Navitas' GaNFast power ICs and GeneSiC power MOSFETs and diodes. GaN and SiC are 'wide bandgap' power semiconductors that deliver higher efficiency at faster switching speeds, with smaller system size and lower costs than legacy silicon chips. These advances will enable EV power conversion systems to deliver faster-charging, faster-acceleration, longer-range and lower-cost EVs which will accelerate our planet's transition from fossil-fuel to clean-air vehicles. The lab will host highly skilled Navitas engineers, working with advanced power system design tools and in close partnership with VREMT system design teams. The joint R&D lab will be further supported by Navitas' own unique EV System Design Center, located in Shanghai. The Design Center assists customers to maximize GaN and SiC performance advantages, including high-frequency magnetics design plus advanced packaging and modules to create higher power density, higher efficiency, and lower system cost power electronics systems for EVs.

08:48 EDT IMAC launches ecommerce website for vitamin, supplement line - IMAC Holdings announces it has launched an e-commerce platform to retail its vitamin and supplement products to consumers nationwide. IMAC recently launched Vita Eternum, an organic, whole-food supplement line using a "seed to bottle" manufacturing process which can now be purchased online at www.vitaeternum.com. The Vita Eternum vitamin and supplement product line includes USDA certified organic Sleep and Stress ashwagandha, Women's Multivitamin, and Men's Multivitamin as well as an unflavored Multi Collagen Protein and Back Multivitamin. The Vita Eternum products retail between $29 and $49 per unit.

08:47 EDT Peloton sees revenue for the year to resemble seasonality of FY22 - Not providing specific revenue or subscriber guidance for the FY.

08:45 EDT ZimVie launches TSX Implant in the U.S. - ZimVie announced the launch of the TSX Implant in the United States, the latest innovation in the company's platform of surgical, restorative, and digital dentistry solutions. TSX Implants are designed for immediate extraction and loading protocols as well as placement predictability and primary stability in soft and dense bone. The TSX Implant incorporates features with more than two decades of real-world, clinical data to deliver peri-implant health, crestal bone maintenance, long-term osseointegration, and prosthetic stability.1-8, 11-13* Integrated with ZimVie's end-to-end digital workflows and engineered with surgical and restorative versatility, the TSX Implant furthers ZimVie's commitment to simplify procedures and optimize practice protocols.

08:44 EDT Huadi International announces strategic plan to enter energy industry - Huadi International Group announced its strategic plan to enter into clean energy industry. The Company has initiated discussion with a local government in Sichuan province, China and plans to invest and construct local production base for anode materials, which are core to the development of clean energy batteries and storage technologies. HUDI's management and the local officials held discussions during several virtual conferences on clean energy development. Among the discussion were the potential investment, product range, technology application, anticipated operational scale and performance of the clean energy initiative proposed by HUDI. Field trips have been scheduled by the local officials to perform due diligence after reviewing and confirming the Company's strategic planning for the new energy business. The Company's strategic plan is aimed to mobilize Sichuan local economic development and improve environment sustainability.

08:43 EDT Color Star Technology changes ticker symbol to "ADD" - Color Star Technology is changing its NASDAQ ticker symbol to "ADD". The company will increase its efforts in artificial intelligence, metaverse and mobile communications segments, and also commence its offline entertainment business as the global environment continues to recover in order. The company's ColorWorld Metaverse platform has become a metaverse social platform with over one million registered users worldwide. The mobile communications segment of Color Star has become another major business focus of the company. The DONOphone metaverse smartphone, which is jointly created with an international company, has been launched. The offline entertainment business, including large-scale exhibitions, celebrity performances and ticket sales, will also become a focus of the company. Color Star will produce various cultural events.

08:43 EDT HUMBL acquires BM Authentics for 90M shares, $110,000 in cash - HUMBL, Inc. announced the acquisition of BM Authentics, a trusted provider of sports merchandise and memorabilia headquartered in Chicago, Illinois. BM Authentics works with clients such as professional athletes, brands, representation and marketing agencies, to provide sports merchandise ranging from autographed jerseys, bats, balls, helmets, photos and more. BM Authentics merchandise will be made available on the HUMBL platform and will be verified, registered and cataloged on blockchain. This will include Certificates of Authenticity, along with cataloging on the BLOCKS Registry, a decentralized global database that can be used for the lifetime tracking of collectible merchandise. The HUMBL Wallet will hold and validate the Certificates of Authenticity, thus providing an additional layer of security with consumer and brand protection over the life of the physical asset or digital collectibles. The purchase price for the transaction was 90,000,000 shares of HUMBL common stock and $110,000 in cash. Brian Foote recently retired 450,000,000 common shares on September 21, 2022 to ensure such a transaction would result in no additional dilution to shareholders.

08:41 EDT Timber Pharmaceuticals announces halt of common stock trading - Timber Pharmaceuticals announced that trading of its shares of common stock has been halted by the New York Stock Exchange due to the low trading price of the Company's shares of common stock on November 1, 2022. The Company expects the trading halt to remain in effect until after Timber's Special Meeting of Stockholders scheduled for November 7, 2022, at which the Company is seeking stockholder approval to complete a reverse stock split in order to regain compliance with NYSE's listing requirements, and consummation of such reverse stock split based on the parameters being voted on at such meeting. Subject to NYSE approval, it is anticipated that trading will resume on the NYSE American following the implementation of the reverse stock split. Although not anticipated by the Company, the Exchange could maintain the trading halt. The Exchange could also suspend trading and move to delist the Company's common stock if the price per share post-split does not meet the requirements of Section 1003(f)(v) of the NYSE American Company Guide. John Koconis, Chairman and Chief Executive Officer of Timber, commented, "We expect this trading halt will remain in effect until shortly after the special meeting of stockholders that will take place on November 7th at 1:00 P.M. and consummation of a reverse stock split consistent with the parameters being voted on at that meeting. Timber's board of directors and management continue to believe in the strength of its clinical development programs including Timber's lead asset, TMB-001, which is in development for the treatment of autosomal recessive congenital ichthyosis and has been awarded Breakthrough and Fast Track designation by the U.S. Food & Drug Administration. These designations will continue to benefit us as we advance through the ongoing pivotal Phase 3 ASCEND trial. Congenital ichthyosis is a painful chronic disease with no approved treatments and Timber is working hard to fulfill the promise of TMB-001 for the many patients in need of an effective treatment."

08:41 EDT Peloton to relaunch digital app in the new year, says CEO - CEO McCarthy says there will be a tiered pricing associated with the new content strategy.

08:40 EDT Emerita Resources reports results from drilling at Romanera deposit - Emerita Resources is pleased to announce additional assay results from the 2022 delineation drilling at the La Romanera Deposit at its wholly owned Iberian Belt West project. IBW hosts three previously identified massive sulphide deposits: La Infanta, La Romanera and El Cura. All deposits are open for expansion along strike and at depth. Presently, there are 13 rigs on La Romanera deposit delineation and 1 rig continues to drill at La Infanta. Six drilling companies are engaged in the program. The most recent drill rig is capable of drilling shallower angle drill holes and will accelerate drilling of some of the thicker, higher base metal grade sections of the deposit, based on the historical intercepts. This area of the deposit was not systematically assayed for gold by previous operators. According to Joaquin Merino, P.Geo., President of Emerita, "The upper central area of the deposit is expected to contain a significant proportion of the historical resource, based on the base metal grades and thickness of the sulphide intervals in the historical drill holes. We are interested to see what the gold values are in this section of the deposit. In addition, we expect to commence drilling the El Cura deposit with two drills after December 1, 2022 which is after the hunting season in the area. El Cura is situated between La Romanera and La Infanta deposits." Additional assay results for the following six drillholes are reported as follows: Holes LR025, LR026 and LR033 are located at the western side of the deposit at various elevations. Holes LR032 and LR006B are in the central part of the deposit and hole LR030 on the eastern side. Drillhole LR025 intercepted only the Lower Lens mineralization from 184.2 m and encountered 11.2 m of massive sulphide mineralization grading 0.4 % Cu; 1.5 % Pb; 4.2 % Zn; 0.8 g/t Au and 60.8 g/t Ag, including 2.8 m grading 0.3 % Cu; 3.8 % Pb; 12.2 % Zn; 1.72 g/t Au and 131.9 g/t Ag. Drillhole LR026 intercepted massive sulphide in the Upper Lens over 16.9m which in this hole comprises mostly pyrite with no significant values of base or precious metals. The Lower Lens occurs 19.5m below the Upper Lens and consists in 16.3 m grading 0.4 % Cu; 0.2 % Pb; 0.4 % Zn; 0.7 g/t Au and 16.0 g/t Ag, including 2.8 m grading 0.6 % Cu; 0.2 % Pb; 0.0 % Zn; 2.0 g/t Au and 38.6 g/t Ag. Drillhole LR033 was drilled into the central-west part of the deposit and intercepted the two lenses of massive sulphides. The Upper Lens occurs from 326.2 m and has 1.9 m grading 0.5 % Cu; 1.5 % Pb; 1.3 % Zn; 1.2 g/t Au and 83.8 g/t Ag. The interval between the Upper and Lower Lenses is 20.1 m. The Lower Lens consists of 1.2 m of low-grade massive sulphides. Drillhole LR032 targeted a zone 250 m below surface in the central part of the deposit. It encountered two lenses of massive sulphides. The Upper Lens occurs from 328.3 m and comprises 4.6 m grading 1.5 % Cu; 0.1 % Pb; 0.0 % Zn; 0.5 g/t Au and 39.1 g/t Ag. The interval between the two lenses is 27.4 m. The Lower Lens consists of 7.5 m grading 0.2 % Cu; 0.7 % Pb; 1.0 % Zn; 1.8 g/t Au and 43.8 g/t Ag, including 2.9 m grading 0.3 % Cu; 0.8 % Pb; 0.9 % Zn; 3.51 g/t Au and 65.9 g/t Ag. Drillhole LR006B intercepted the Upper Lens from 472.7 m where it is only 0.5 m thick grading 0.4 % Cu; 1.4 % Pb; 2.2 % Zn; 1.3 g/t Au and 92.0 g/t Ag. The Lower Lens was intercepted 5.5m below and is also characterized by massive sulphide mineralization. The Lower Lens intercept consists of 40.7 m grading 0.3 % Cu; 0.7 % Pb; 0.5 % Zn; 1.6 g/t Au and 32.3 g/t Ag, including 4.8 m grading 0.2 % Cu; 1.3 % Pb; 1.8 % Zn; 4.2 g/t Au and 64.2 g/t Ag with a second high grade gold interval of 3.0 m grading 0.4 % Cu; 0.4 % Pb; 0.3 % Zn; 6.54 g/t Au and 47.8 g/t Ag. Drill hole LR006B shows that excellent gold grades continue to be present at this elevation, approximately 400 m below surface. Drillhole LR030 intercepted mineralization at 300 m below surface in the eastern side of the deposit. It encountered the Upper and Lower massive sulphide lenses. The Upper Lens occurs from 325.4 m down the hole and comprises 5.3 m grading 0.1 % Cu; 0.6 % Pb; 10.2 % Zn; 0.4 g/t Au and 54.5 g/t Ag. The interval between the lenses is 26.1 m. The Lower Lens intercept consists of 6.3 m grading 1.1 % Cu; 0.4 % Pb; 0.7 % Zn; 1.1 g/t Au and 21.4 g/t Ag. Hole LR030 is located approximately 100 m east of the historical Upper Lens drilling and appears to mark a significant extension of the Upper Lens massive sulfides to the east in this area. Copper and gold grades are significant in the Lower Lens in this hole.

08:38 EDT Mind Medicine investor demands investigation into misconduct allegations - FCM MM HOLDINGS notifies shareholders that it has formally filed a complaint with the Securities and Exchange Commission and will file a referral to the Department of Justice regarding allegations against Mind Medicine. The Complaint focuses on the following allegations: self-dealing, lack of material disclosure, false statements/public statement fraud, and if the allegations are true, criminal activities, by CEO Robert Barrow, under Sarbanes-Oxley. The Complaint presents and analyses the allegations in the lawsuit Freeman v. Burbank et al. that MindMed's intellectual property was mishandled due to a one-sided deal negotiated by Mr. Stephen Hurst, then MindMed's CEO, and Mr. Carey Turnbull, CEO of Ceruvia Lifesciences. Mr. Hurst founded Ceruvia's predecessor, purportedly in secret. If the Deal occurred, Ceruvia has undisclosed freedom to operate on MindMed's IP surrounding LSD and its derivatives, and MindMed is not able to research or compete on BOL-148. The Complaint also lists Ceruvia executives who concurrently worked for MindMed during Messrs. Hurst and Barrow's tenure and the implications for MindMed's IP and trade secrets. Additionally, the Complaint scrutinizes whether MindMed adequately disclosed to investors the significant risk of MM-110's failure in gaining full Food and Drug Administration product approval. After MindMed terminated the MM-110 program in August of 2022, FCM conducted a rigorous review of publicly available data of MM-110, a core drug of MindMed, from primarily both MM-110's patent application and protocol of the Phase I trial, which were available prior to the initiation the Study. The Complaint addresses FCM's conclusion that it is highly unlikely the FDA would have allowed the Study to be performed in the US as written - i.e. patients would be treated at a dose thirty-five times higher than the comparable dose which caused death in mice. Ultimately, MindMed instead performed the Study in Australia, and in May 2022, reported that the Study's topline results were favorable regarding safety and tolerability and builds on "encouraging" results from pre-clinical studies. The Results were then presented to the FDA, and MindMed later disclosed that the FDA now requires MindMed to complete a myriad of pre-clinical safety studies prior to instituting additional clinical trials in the US. Mr. Barrow stated that the Pre-Clinical Studies could take years, and MindMed subsequently shuttered the program. The Complaint also examines the departures of several high-profile executives of the Company right before they were required to sign off on MindMed's SEC filings. Similar to Chief Legal Officer Cynthia Hu who left one month prior to being required to sign MindMed's stock offering, Chief Financial Officer David Guebert resigned from MindMed the business day before he was obligated to make his first Sarbanes-Oxley certification of MindMed's financials. The Complaint further notes that MindMed's auditor Ernst & Young was fired shortly after reporting that MindMed had a material weakness in its internal controls under Sarbanes-Oxley.

08:36 EDT Daxor announcew new study on utility of its BVA-100 blood test in HF - Daxor announces a new study in the prestigious Journal of Cardiac Failure demonstrating the importance and clinical utility of Daxor's BVA-100 blood test in heart failure, HF. The researchers showed that Daxor's BVA-100 was able to measure intravascular volume overload in heart failure patients - a key metric targeted to successfully manage heart failure. Common surrogate markers and clinical evaluation to assess volume overload in contrast were shown to be ineffective at making a comparative clinically actionable measure, despite common usage in many hospitals. The study titled, "Blood Volume Analysis and Hemodynamic Measures of Vascular Compliance in Patients with Worsening Heart Failure," assessed the relationship between blood volume, resting, and stress cardiovascular pressures in worsening HF. The study results showed little to no correlation between patient symptoms, physical exam or cardiac pressures as compared to direct blood volume measures. "More than 6 million Americans suffer from heart failure, one of the most prevalent, complex, and deadly diseases leading to nearly one million deaths and one million hospitalizations annually," said Michael Feldschuh, CEO and President of Daxor Corporation. "Worsening HF is associated with exceedingly high 30-day mortality and risk for rehospitalization. Our test informs clinicians with critical information to help manage and treat volume derangements in complex HF patients and past studies in peer-reviewed journals have shown substantial improvements in reducing mortality, hospital readmission, length of stay, and costs from the use of our diagnostic."

08:35 EDT Nordic Semiconductor extends partnership with Memfault - Memfault announced an extension of its partnership with Nordic Semiconductor to give Bluetooth Low Energy developers building on nRF52 and nRF53 Series easy access to Memfault's device reliability engineering capabilities. The updated integration gives nRF52 and nRF53 Series developers the same streamlined experience as nRF91 Series developers with an out-of-the-box integration of the Memfault platform to accelerate product development, derisk product launches, and ship more robust, always-improving products.

08:34 EDT Peloton sees demand for Conneted Fitness hardware remaining challenged - The company said: "Given macro economic uncertainties we believe near-term demand for Connected Fitness hardware is likely to remain challenged. Our forecast incorporates a seasonal mix-shift toward our Connected Fitness segment, expected holiday promotional activity, a mix-shift of sales toward our rental program, as well as the impact from expanding our third-party retail partnerships. We expect Connected Fitness churn to be similar to 1Q. Over the course of FY'23 we anticipate approximately $70 million of additional restructuring related cash charges, a portion of which we expect to impact 2Q."

08:34 EDT Midwest Energy Emissions defers all major debt - Midwest Energy Emissions announced that it has reached an agreement that extends the maturity date of the Company's entire unsecured and secured debt obligations until August 25, 2025 The principal financial partner is the holder of an unsecured note with a principal amount outstanding of approximately $13.2M and a secured note with a principal amount outstanding of approximately $270,000. The notes were originally scheduled to mature on August 25, 2022, which has now been extended for three years. In addition, interest on the secured note, which note has been longstanding, has been reduced from 15.0% to 9.0% per annum. The unsecured note, as originally constituted, bears zero interest and entitles the lender to a certain non-recourse profit share. As part of the changes being announced, the lender has also been given an additional non-recourse profit share under the unsecured note. In addition, the Company has negotiated a repurchase option which, at the Company's sole discretion, allows for the Company's buyback of a significant portion of stock held by the lender at a price of $0.50 per share.

08:33 EDT Verano Holdings launches BITS edibles line - Verano Holdings Corp. announced the launch of BITS, a new line of low-dose, high-function edibles that allow cannabis consumers to do more with less. Each of BITS' five initial flavors offer a blend of 5 mg of THC, complementary cannabinoids and adaptogens designed to enhance not overtake, and to make the cannabis edible experience less intimidating, more accessible and enjoyable. Beginning November 4, 2022, the new product line from Verano will be available across the Company's Zen Leaf dispensaries and third-party retail locations in six core markets: Illinois, Maryland, Massachusetts, Nevada, New Jersey and Ohio, with additional rollouts in Arizona and Florida expected in the near future.

08:33 EDT LPL Financial to acquire Financial Resources Group Investment Services - LPL Financial announced that the firm has entered into a definitive purchase agreement to acquire Financial Resources Group Investment Services, FRGIS, an LPL branch office supporting financial institutions and advisors, headquartered in Fort Mill, South Carolina. FRGIS will continue to operate independently within LPL following the closing of the acquisition (the "Closing"), retaining its brand and leadership team. "We are excited to embark on this new phase of our relationship with our deeply respected, long-standing partner, FRGIS," said Rich Steinmeier, LPL Financial managing director and divisional president, Business Development. "This acquisition strengthens our relationship with a strategically important client and provides a foundation on which to accelerate expansion of several strategic growth areas, particularly in the financial institution space. FRGIS is an industry leader of managed programs for banks and credit unions and provides a strategic complement to LPL's existing enterprise offering." The transaction is structured as an equity purchase and is anticipated to close in early 2023, subject to receipt of regulatory approval and other customary closing conditions. The purchase price includes $140 million to be paid at the Closing, subject to standard adjustments included in the definitive purchase agreement, with additional earn-out payments over the three years following the Closing.

08:32 EDT iBio seeking to divest its contract development, manufacturing organization - iBio announces it is seeking to divest its contract development and manufacturing organization in order to complete its transformation into an antibody discovery and development company. Proceeds and cost-savings from the divestiture of the CDMO facility and reduction in operations will be invested in advancing the Company's lead immuno-oncology assets towards the clinic, as well as the continued development of the RubrYc Discovery Engine, the artificial intelligence platform used to create the majority of iBio's therapeutic candidates, and intended to extend the Company's cash runway. "We currently possess valuable assets in both biomanufacturing and biotech," said Tom Isett, CEO of iBio. "We believe focusing our efforts on drug discovery and development to be the path to greatest value-creation for shareholders, especially given the recent addition of RubrYc Therapeutics' pipeline and tools to engineer precision-targeting antibodies. Concurrently, given the strong demand for biomanufacturing capacity, we are providing the opportunity for another organization to more fully utilize the advanced bioanalytical and bioprocess capacity resident in our large-scale cGMP biologics production facility located in the growing Southeast Texas 'Biocorridor'. We are expecting to complete the CDMO divestiture in 2023, while we focus on advancing our lead preclinical program and our expanding pipeline and partnership opportunities." Following a detailed review of its pipeline and growth opportunities, iBio will focus its resources on the continued development of its lead immuno-oncology assets including, IBIO-101, an immunotherapy for the depletion of regulatory T cells, and two differentiated, antibody candidates emanating from its antibody discovery platform, EGFRvIII and CCR8. In pre-clinical research, each demonstrates specificity for its target and a high degree of cell-killing capability, with potentially reduced off-target effects. The transition to a focused AI-Biotech business is expected to reduce iBio's monthly burn rate by approximately half, or approximately $2.5-3.0 million per month. Assuming an asset sale at levels comparable with other similar cGMP facilities, the Company believes that cost reductions in conjunction with proceeds from asset sales could provide cash runway into the first half of calendar year 2024.

08:30 EDT Theriva announces first patient dosed in second cohort of Phase 1b/2a trial - Theriva Biologics announced the first patient has been dosed in Cohort 2 of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 in allogeneic hematopoietic cell transplant recipients for the prevention of acute graft-versus-host-disease. "We are encouraged by the growing evidence that demonstrates SYN-004 has the potential to reduce serious adverse events in patients undergoing allogeneic HCT to treat hematologic cancers, and are pleased with the program's continued clinical advancement as part of our oncology-focused pipeline," said Steven Shallcross, Chief Executive Officer of Theriva Biologics. "We are very grateful for the tremendous support from Dr. Dubberke and his team at Washington University as we continue our progress towards improving treatment outcomes for these highly susceptible patients by overcoming existing limitations of broad-spectrum IV beta-lactam antibiotics."

08:27 EDT RioCan REIT announces renewal of Normal Course Issuer Bid - RioCan Real Estate Investment Trust announced that the Toronto Stock Exchange has approved its notice of intention to make a normal course issuer bid for a portion of its trust units as appropriate opportunities arise from time to time. RioCan's normal course issuer bid will be made in accordance with the requirements of the Toronto Stock Exchange. Pursuant to the notice, RioCan is authorized to acquire up to a maximum of 30,247,803 of its 303,413,346 outstanding Units, or approximately 10% of the public float of 302,478,039 as of October 31, 2022 over the next 12 months. Purchases under the normal course issuer bid will be made through the facilities of the Toronto Stock Exchange or through a Canadian alternative trading system and in accordance with applicable regulatory requirements at a price per Unit equal to the market at the time of acquisition. The number of Units that can be purchased pursuant to the bid is subject to a current daily maximum of 207,826 Units, subject to RioCan's ability to make one block purchase of Units per calendar week that exceeds such limits. Units purchased under the normal course issuer bid will be cancelled upon their purchase, or may be used to satisfy RioCan's obligation to deliver Units under RioCan's Restricted Equity Unit Plan and/or Performance Equity Unit Plan. RioCan intends to fund the purchases out of its available cash and undrawn credit facilities. Under its previous normal course issuer bid, which expired on October 21, 2022, RioCan was authorized to acquire a total of 31,616,150 Units of which 13,956,020 Units were purchased by RioCan at a weighted average price of $21.9806 per Unit. RioCan may begin to purchase Units on November 7, 2022 and the bid will terminate on November 6, 2023 or such earlier time as RioCan completes its purchases pursuant to the bid or provides notice of termination. RioCan believes that the purchase of its Units may represent an investment opportunity for the Trust and an appropriate and desirable use of its funds based on market conditions, Unit price and other factors.

08:26 EDT Olink announces 1,000 peer-reviewed articles citing use of PEA technology - Olink announced the achievement of more than one thousand peer-reviewed publications citing the use of Olink Proximity Extension Assay technology, underscoring the widespread adoption and successful application of its protein biomarker solutions by the scientific community. "We are delighted that so many outstanding scientists have been able to use our protein biomarker solutions to further their important research and produce this exceptional body of high-quality publications," said Dr. Ida Grundberg, Chief Scientific Officer, Olink. "Peer-reviewed publications are the lifeblood of the research community, representing a key measure of success for scientists, driving progress towards a deeper biological understanding of human health and disease, and providing the foundation to develop new and better therapies."

08:26 EDT Marriott says wage, benefit growth continues to moderate - Expects 2023 RevPAR "up nicely," with particular strength in Q1. Expects significant pent up travel demand in 2023.

08:25 EDT Rhythm announces 11 presentations at he Obesity Society's annual meeting - Rhythm Pharmaceuticals announced a total of 11 presentations at The Obesity Society's Annual Meeting at ObesityWeek being held November 1-4, 2022 in San Diego. Results from the Clinical Registry Investigating Bardet-Biedl Syndrome - In a poster titled, "Substantial Burden Associated With Hyperphagia and Obesity in Children With Bardet-Biedl Syndrome," researchers assessed mean and median hyperphagia scores by weight category and evaluated the correlation between hyperphagia score and BMI percentile for 39 children with BBS who completed the Hyperphagia Questionnaire with scores that range from 11 to 55, with higher values indicating more significant hyperphagia. An additional poster presented by Dr. Pomeroy, titled, "Natural History of Weight Gain in Children With Bardet-Biedl Syndrome: Results From the Clinical Registry Investigating Bardet-Biedl Syndrome," includes analyses of data from 331 children aged 3 to 17 years with BBS were designed to improve understanding of weight gain patterns. highlights include: At the first CRIBBS assessment, 9% of children were classified as overweight and 81% were classified as obese; 29 of children included in the natural history subset had class III obesity at baseline; Overall, 67.5% of children with obesity at baseline remained in the same or moved to a higher obesity class by the last assessment greater than or equal to2 years later; and In the full analysis population and natural history subset, 22.7% and 32.3% of children with obesity reported using weight loss interventions, respectively, with the majority experiencing additional weight gain. Clinical benefit of treatment with setmelanotide in BBS Phase 3 clinical trial: Researchers investigated the impact of setmelanotide across weight, hunger, and quality of life in patients aged 6 years and older with BBS and obesity who participated in Rhythm's Phase 3 clinical trial. Highlights include: 27 of 32 patients had clinical improvements that met thresholds in greater than or equal to1 measure at the last study visit; 30 of 32 patients experienced clinical improvement or weight stabilization; 10 of 11 evaluable patients experienced greater than or equal to1-point reduction in maximal hunger score; 18 of 19 evaluable patients experienced a meaningful or positive nonmeaningful improvement in QOL; and Setmelanotide was observed to be generally well tolerated; 1 patient discontinued study drug during placebo treatment due to an AE.

08:24 EDT Royal Caribbean: FY23 booked well within historical ranges - Booking volumes in the third quarter accelerated versus the second quarter of 2022 and remained significantly higher than booking volumes received in the third quarter of 2019 for all future sailings. For 2023, all quarters are currently booked well within historical ranges at record pricing, the company said.

08:21 EDT Capriotti's joins Mobivity's Connected Rewards program - Capriotti's Sandwich Shop has launched a new program with Mobivity Holdings, a contextual performance network provider that connects national restaurants, retailers, and their partners to the more than 200 million game players in the U.S. With this new program, Capriotti's can now attract new customers and reward existing ones with privacy-safe, targeted offers through in-game exposure and rewards. Mobivity's Connected Rewards technology and partnerships with leading game publishers have universal appeal given that 73% of the population between ages 13 to 64 play games at least one hour a week. As consumers play, they can earn in-game rewards from brands they love. Through Capriotti's partnership with Mobivity, these same players will have the opportunity to unlock Capriotti's discounts and offers by spending their earned tokens. Capriotti's Rewards will be promoted both inside the game and through e-mails and social postings tied to the game.

08:19 EDT Jushi Holdings announces opening of relocated scranton dispensary - Jushi announced the opening of its relocated Beyond Hello Westside dispensary in Pennsylvania, through its subsidiary, Pennsylvania Dispensary Solutions. "Beyond Hello Dickson City is located just two minutes from I-81, the Viewmont Mall and a host of hotels, restaurants, shops and grocery stores," said Jim Cacioppo, Chief Executive Officer, Chairman and Founder of Jushi Holdings Inc. "Designed by our in-house team, this new store features a lighter, brighter color palette with a focus on display cases that highlight our curated selection of medical marijuana products and accessories. With plenty of parking spots and a seamlessly integrated shopping experience with beyond-hello.com, Beyond Hello Dickson City is well located to serve patients across the Greater Scranton Area."

08:17 EDT Irwin Naturals to acquire assets of Care Clinic in Florida, terms not disclosed - Irwin Naturals entered into a binding agreement on October 30, 2022, to acquire the assets of Clare Clinic, Inc., d/b/a Florida Mind Health Center, which operates three healthcare clinics in Florida. The clinics are located in Gainesville, Tallahassee and Panama City, and offer ketamine-assisted therapy, NAD+ and other IV therapies. Those clinics will join Irwin Naturals Emergence, a fast-growing national chain offering psychedelic mental healthcare that already includes five clinics in Florida. Earlier this year, the Company announced it intended to move to the forefront of psychedelic mental healthcare by assembling a national chain of clinics. For more than six months now, Irwin Naturals Emergence has been vetting the more than 600 independent ketamine clinics currently operating in the United States, seeking to identify profitable clinics that practice the standard of customer care consistent with the Irwin Naturals brand. The company invited those clinics that met its criteria to join the family, so to speak, and become part of Irwin Naturals Emergence, which is a wholly owned subsidiary of Irwin Naturals.

08:15 EDT NFI Group named partner of choice for over $380M grants - NFI Group announced that NFI subsidiary New Flyer of America has been named partner of choice by a total of 38 major transit agencies across the United States for its successful project awards from the Federal Transit Administration's 2022 Low or No Emission and Buses and Bus Facilities Grant Programs. New Flyer supported the successful applications for over $380 million in grants awarded to 38 U.S. public transit agencies and was the named partner for two individual agency awards of over $25 million each. While New Flyer has been named as a partner, new awards will not be added to NFI's backlog until contract documentation is completed and a formal purchase order is received. "NFI is proud that subsidiary New Flyer has been selected as the partner of choice for numerous public transit agencies as they look to reduce emissions in their cities through these FTA grant programs" said Chris Stoddart, President, North American Bus and Coach, NFI. "Our success demonstrates NFI's leadership in low- and zero-emission buses, including our wide range of battery- and fuel cell-electric products and our Infrastructure Solutions offering charging. The growth in these FTA grant programs, from $182 million in 2021 to over $1.6 billion of funding in 2022, is a testament to the strong tailwind of public support that will inevitably transform America into an electric bus future. NFI looks forward to continuing to lead the evolution to zero-emission mobility- what we call the ZEvolution."

08:14 EDT Inozyme announces first self-administration of INZ-701 - Inozyme Pharma announced the first self-administration of INZ-701 in the open-label Phase 2 extension portion of the ongoing Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency. The implementation of self-administration of INZ-701 followed Inozyme's submission of a protocol amendment to the U.S. Food and Drug Administration and approval of a protocol amendment submitted to the German Federal Institute for Drugs and Medical Devices. The Company has also submitted documentation to additional ex-U.S. regulatory agencies to allow self-administration. These submissions were supported by preliminary safety data from the ongoing trial. "This is a significant milestone for a product candidate at this stage of its clinical and regulatory pathway and we believe highlights the safety profile of INZ-701 to date in our ongoing Phase 1/2 clinical trial," said Kurt Gunter, M.D., Inozyme's senior vice president and chief medical officer. "Self-administration opens up a convenient dosing option for patients in the Phase 2 extension. The extension portion of the trial is designed to provide important long-term safety and clinical data and support the development of INZ-701 as the first potential approved therapy for ENPP1 Deficiency."

08:13 EDT Marriott expects 'additional upside' from international travel - Says "yet to see slowdown" in international demand. Says travel spending has been "incredibly resilient." Sees FY22 gross room growth of 4.5% vs. prior view of 5%. Expects "solid room growth" going forward. Comments taken from Q3 earnings conference call.

08:09 EDT Planet Fitness announces executive leadership appointments - Planet Fitness has promoted Jennifer Simmons, previously Senior Vice President of Business Strategy and Analytics, to Division President, Corporate Clubs, and Paul Barber has been appointed Chief Information Officer, effective immediately. Simmons joined Planet Fitness in 2013 and most recently served on the executive leadership team as Senior Vice President of Business Strategy and Analytics. Barber will lead the company's technology evolution and strategy, focused on delivering technology solutions that will continue to enhance the member experience while optimizing infrastructure, data, and operations for flexibility and scale. Previously, he was the Chief Technology Officer at Airline Report Corporation.

08:07 EDT Lipocine appoints Chief Medical Officer, Chairman of the Board - Lipocine appointed George Nomikos as Chief Medical Officer and Spyros Papapetropoulos as Lead Director and Chairman of the Board. George Nomikos is a biopharmaceutical R&D scientist and psychiatry-trained clinician who until recently served as SVP, Medical & Clinical Sciences at Scholar Rock, a clinical-stage biopharmaceutical company, where he oversaw clinical development and medical functions of neuromuscular therapeutics. Dr Nomikos previously held senior positions at Biogen, Sage, Takeda, Astellas, Amgen and Eli Lilly. Papapetropoulos has been a member of Lipocine's board since April 2022. He is currently Chief Medical Officer at Vigil Neuro. Previously he served as Chief Development Officer, and SVP, Head of Development at Acadia Pharmaceuticals, CEO at SwanBio Therapeutics, and Head of Research & Development and Chief Medical Officer at Cavion.

08:06 EDT Pacira not providing revenue, gross margin guidance - Since early 2020, the company's revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise. Given the continued uncertainty around labor shortages, COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. The company is reiterating its full-year 2022 operating expense guidance as follows: Non-GAAP R&D expense of $75 million to $85 million; and Non-GAAP SG&A expense of $220 million to $230 million. Stock-based compensation of $47 million to $50 million.

08:03 EDT Helius Medical to showcase new PoNS device - Helius Medical Technologies will showcase its innovative new Portable Neuromodulation Stimulator, PoNS, at the 99th annual American Congress of Rehabilitation Medicine, ACRM, Conference, held November 8-11 in Chicago. "The ACRM is committed to helping people live their fullest lives by improving, expanding and regaining mobility, and we're excited to exhibit at the Conference because we share the same goals," said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. "PoNS addresses a complication that's very top-of-mind for people with MS: 70% of them report having difficulty walking, and of that group 70% identify gait deficit as the most challenging aspect of their disease."

07:59 EDT Atea Pharmaceuticals presents Phase 1 data for AT-752 - Atea Pharmaceuticals presented a poster highlighting favorable AT-752 Phase 1 clinical data for the treatment of dengue fever at the American Society of Tropical Medicine & Hygiene, ASTMH, 2022 Annual Meeting in Seattle, Washington. The poster is titled, "Safety, tolerability, and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus: results from a Phase 1, first-in-human, dose-escalation study." "Dengue is the most prevalent mosquito-borne virus and despite its alarming increase over the last two decades, there are no direct-acting antiviral treatments available," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "These data demonstrate that AT-752 was well tolerated up to the highest dose tested and rapidly achieved plasma levels above the in vitro EC90. Based on these data, we anticipate that AT-752 may have the potential to rapidly inhibit dengue virus replication across all serotypes. In addition, AT-752 exhibited no pharmacokinetic sensitivity across varying ethnic populations participating in the trial." Atea is currently conducting two AT-752 clinical studies. The first study is a global, randomized, double-blind, placebo-controlled Phase 2 trial in adult patients with dengue virus infection. The study is designed to evaluate the antiviral activity, safety and pharmacokinetics of multiple doses of AT-752 in areas where dengue is endemic. The second study is a human challenge study that is being conducted in the United States. The challenge study is designed to evaluate healthy subjects who are challenged with a Dengue Virus-1 Live Attenuated Virus strain after receiving AT-752 or placebo.

07:58 EDT Vectivbio completes enrollment for CIC cohort of STARS study - VectivBio Holding announced the completion of enrollment of the Colon-in-Continuity cohort for the company's Phase 3 STARS pivotal study investigating the long-acting synthetic GLP-2 agonist apraglutide in Short Bowel Syndrome with Intestinal Failure. STARS is a pivotal, global Phase 3 study enrolling approximately 144 patients with SBS-IF stratified 50/50 for CIC and stoma, with patients being evaluated over 48 weeks and 24 weeks respectively. This stratification will allow for the evaluation of anatomy-specific key secondary endpoints. Patients are randomized 2:1 for either once-weekly-apraglutide or placebo. The study includes an improved PS weaning algorithm tailored to remnant bowel anatomy to enhance signal detection. STARS is designed to establish a new standard of care for all patients with SBS-IF and to tailor apraglutide treatment to patients with distinct remnant bowel anatomy. The Phase 3 study is being conducted globally in 18 countries and over 80 sites.

07:57 EDT Merus sees cash, equivalents sufficient to fund operations beyond 2024

07:57 EDT GXO Logistics expands partnership with Floyd - GXO Logistics will hold a ribbon-cutting ceremony to celebrate the expansion of its partnership with innovative furniture designer and manufacturer Floyd that began in 2019. The new warehouse space, situated in a GXO Direct facility, a shared space solution in Horn Lake, Mississippi, is 120,000 square feet and will be used for picking and packing large furniture items as well as supporting kitting and returns management. Floyd uses GXO Direct to achieve highly efficient picking and packing, gain real-time visibility into its inventory levels and to put its inventory within one- or two-day ground delivery of approximately 99% of the U.S. population, reducing time-in-transit as well as damage rates and losses.

07:55 EDT Maquia Capital Acquisition announces adjournment of special meeting - Maquia Capital Acquisition Corporation announced that its special meeting in lieu of annual meeting of stockholders, which was originally scheduled for Tuesday, November 1, 2022 and was postponed to Thursday, November 3, 2022, has been adjourned to 10 a.m., Eastern Time, on November 4, 2022. At the Meeting, stockholders will be asked to vote on a proposal to approve an extension of the date by which Maquia must consummate an initial business combination from November 7, 2022 to May 7, 2023, or such earlier date as determined by the Company's board of directors. As of 5:00 pm Eastern Time on November 2, 2022, Maquia has received requests to redeem a total of 14,781,810 shares of Class A common stock, which requests may be withdrawn at any time prior to the Meeting, or such other date as the chairman of the board of directors may determine to be the deadline for accepting withdrawals of such redemption requests. Stockholders who wish to withdraw their previously submitted redemption requests may do so prior to the Meeting by requesting the Company's transfer agent Continental Stock Transfer & Trust Company to return such shares. If all of the redemption requests received by Maquia as of November 2, 2022 are satisfied by Maquia, the 14,781,810 shares of Class A common stock, representing 82.61% of the total outstanding shares of Class A common stock of Maquia as of November 2, 2022, would be redeemed.

07:55 EDT InfuSystem and Sanara MedTech announce wound therapy partnership - InfuSystem (INFU) and Sanara MedTech (SMTI) announced the establishment of a partnership, SI Wound Care, focused on delivering a complete wound care solution targeted at improving patient outcomes, lowering the cost of care, and increasing patient and provider satisfaction. The partnership is expected to enable InfuSystem to offer innovative products including Cork Medical negative pressure wound therapy devices and supplies and Sanara's advanced wound care product line to new customers through the jointly controlled entity.

07:53 EDT Quoin Pharmaceuticals announces updated Q3 conference call timing - Quoin Pharmaceuticals announced updated timing for its third quarter 2022 business update conference call and webcast. The conference call and webcast will now take place at 10:00am ET on Thursday November 10th, 2022. The third quarter 2022 financial results will be reported before the open of the financial markets on the same day, Thursday November 10, 2022.

07:52 EDT Aecom selected for major works package in Melbourne, Australia - Aecom has been selected, with partners Acciona and MACA Civil, as the Preferred Proponent to develop a plan to deliver the North Package, a major package of works with the North East Link Program, Victoria, Australia - the state's biggest road project and largest ever investment in Melbourne's north-east. Aecom is expected to provide a range of engineering, design, and advisory services to support the development and delivery of the project.

07:50 EDT Kura Oncology enters financing transactions with Bristol-Myers Hercules Capital - Kura Oncology (KURA) announced a $25 million equity investment from Bristol Myers Squibb (BMY) and a term loan facility with access to up to $125 million from Hercules Capital, Inc. (HTGC). If the term loan is fully drawn, proceeds from these two transactions together with existing cash are expected to fund Kura's current operating plan into 2026. Kura has agreed to sell 1,370,171 shares to Bristol Myers Squibb at a price of $18.25 per share for gross proceeds of $25 million. The shares of common stock were offered and sold to Bristol Myers Squibb in a registered direct offering. In connection with the equity investment, Bristol Myers Squibb will appoint a member to Kura's Global Steering Committee. Kura will maintain full ownership and control of its programs and operations. Under the terms of the loan agreement with Hercules Capital, $10 million will be drawn immediately after closing and an additional $15 million is immediately available to Kura at its sole discretion. Kura may draw an additional $75 million in two separate tranches upon achievement of near-term clinical milestones. An additional $25 million may be drawn in a fourth tranche, subject to the approval of Hercules Capital. The loan bears an initial interest rate of 8.65% and adjusts with future changes in the prime rate. Kura will pay interest only for the first 24 months, extendable to up to 48 months on achievement of certain milestones. The loan matures 60 months from closing in November 2027.

07:49 EDT Nuwellis announces peer reviewed data on kidney replacement therapy - Nuwellis announced the publication of promising clinical data supporting the use of kidney replacement therapy with ultrafiltration to treat preterm, low weight neonates with end-stage kidney disease in Pediatrics. The investigator-led, retrospective study examined seven preterm neonates with end-stage kidney disease who were successfully managed using an innovative approach to kidney replacement therapy using a physician modified Aquadex SmartFlow ultrafiltration system, which is cleared by the U.S. Food and Drug Administration only for use in adults and pediatric patients weighing 20 kg or more. Five of the seven newborns survived to hospital discharge. "Physicians continue to express the urgent need for neonatal fluid management therapies designed to support small children and infants," said Nestor Jaramillo, Jr., President and CEO of Nuwellis. "We remain committed to developing safe innovations and bringing them to market as quickly as possible to address this critical unmet need. This patient population continues to be an important and fast-growing segment of our business."

07:47 EDT Microbot Medical receives additional patent allowance in Israel - Microbot Medic continues to aggressively protect its global intellectual property portfolio for the LIBERTY Robotic System as an additional patent allowance was issued by the Israeli Patent Office, covering the modular concept, and compliments a corresponding application that was previously granted by the U.S. Patent and Trademark Office. The allowed claims cover the unique modular and versatile design of the LIBERTY Robotic system allowing for the manipulation of a variety of tools. The Company expects the allowed claims to reinforce the position of the LIBERTY Robotic System as the first fully disposable, fully sterilized, robotic system for endovascular procedures.

07:44 EDT Virax Biolabs launches RSV-Influenza-COVID Triple Virus Antigen Rapid Test Kit - Virax Biolabs announced the distribution of a RSV-Influenza-COVID Triple Virus Antigen Rapid Test Kit has been launched in markets accepting the CE mark, such as the European Union. The test kits are for use in both at-home and in point-of-care settings to accurately identify infections related to respiratory syncytial virus, influenza and COVID-19 with results typically available in 15 minutes. The specialized diagnostic kits can be found by contacting the company's sales representatives.

07:42 EDT Creative Medical Technology: FDA clears IND application for AlloStem - Creative Medical Technology announced that the U.S. FDA has cleared the company's Investigational New Drug application, enabling the company to proceed with initiating a clinical trial for Type 1 Diabetes using AlloStem.

07:38 EDT Kura Oncology expects cash to fund operations into 2026 - Cash, cash equivalents and short-term investments totaled $427.8 million as of September 30, 2022, compared with $518.0 million as of December 31, 2021. Management believes that cash, cash equivalents and short-term investments, plus cash from the term loan facility from Hercules, if fully drawn, will be sufficient to fund its current operating plan into 2026.

07:35 EDT Northern Oil and Gas raises quarterly cash dividend 20% to 30c per share - The dividend is payable on January 31, 2023, to stockholders of record as of the close of business on December 29, 2022.

07:32 EDT Moderna sees revenue from APAs for product sales $18B-$19B in 2022 - Advance Purchase Agreements: Revenue from Moderna's APAs for product sales for anticipated delivery in 2022 are expected to be $18-19 billion, reflecting deferrals of $2-$3 billion to 2023. Cost of Sales: Cost of sales as a percentage of product sales are now expected to be 26-28% of sales, with the upper end of the range potentially driven by further charges due to product updates. Research & Development and Selling, General & Administrative Expenses: Full-year expenses are expected to be approximately $4 billion. Tax Rate: The Company expects an effective tax rate for the full year in the low- to mid-teen percentage range. Capital Expenditures: The Company expects capital investments for 2022 of approximately $0.5 billion.

07:29 EDT MDU Resources authorizes strategic review for MDU Construction Services Group - As the next step of MDU Resources' strategic planning, the board of directors has unanimously determined the best way to optimize value would be to create two pure-play companies: a leading construction materials company and a pure-play regulated energy delivery company. Accordingly, the board has authorized management to commence a strategic review process for MDU Construction Services Group, Inc. with the objective of achieving the board's goal of creating two pure-play public companies. MDU Resources is working to complete the separation of Knife River, which, as previously announced, is expected to be effected as a tax-free spinoff to MDU Resources shareholders to be completed in 2023. Knife River is a top producer of construction aggregates in the United States. "We believe these steps will unlock significant value for MDU shareholders," CEO Goodin said. "Having two pure-play companies would provide each company the opportunity to execute its individual business plans and achieve industry-leading performance."

07:25 EDT Teleflex recalls certain Gibeck Iso-Gard Filter products - Teleflex has announced a worldwide recall of affected lots of the below-referenced Gibeck Iso-Gard Filter products. The Gibeck Iso-Gard Filter is a bacterial and viral filter, intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. Teleflex initiated this voluntary recall on August 29, 2022 due to reports received indicating that the device split or detached during use. Teleflex is currently issuing an expansion to this recall to include additional lots. Select lots of the device manufactured between December 17, 2019 and March 26, 2022 are subject to this recall and its expansion.

07:25 EDT Focus Financial CFO sees resiliency, stability of results to continue - Jim Shanahan, Chief Financial Officer of Focus, said: "The strength of our results this past quarter was again evident, as we exceeded our guidance on all measures. Our performance benefitted from our diversified sources of revenue, the highly variable nature of our management fees and our structural earnings preference. We expect that the resiliency and stability of our results will continue to be evident as we navigate the current market turbulence. We are executing well against our M&A pipeline, and we remain confident that we will weather the current challenges and emerge well-positioned to capitalize on the forward growth opportunity within our industry. Our international partnership of 87 like-minded firms, led by dynamic management teams, is highly differentiated in the independent wealth management space. Our value proposition continues to resonate with firms in the industry and we are a highly sought-after partner."

07:22 EDT Wesco sees FY22 revenue growth 12%-14%, reported sales up 15%-17% - Revenue consensus is $21.27B. Sees FY adjusted EBITDA margin 7.9%-8%. Comments taken from Q3 earnings conference call presentation slides.

07:18 EDT Agios Pharmaceuticals expects cash to fund operations through catalysts - Cash, cash equivalents and marketable securities as of September 30, 2022, were $1.0 billion compared to $1.4 billion as of September 30, 2021. This cash position does not include the receipt of a one-time payment of $131.8 million associated with the sale of royalty rights on U.S. net sales of Servier's TIBSOVO. Agios expects that its cash, cash equivalents and marketable securities will enable the company to execute its operating plan through major catalysts and to cash-flow positivity without the need to raise additional equity.

07:12 EDT Crocs sees Crocs Brand revenues $5B by 2026 - Expects: HEYDUDE Brand revenues to now be over $1.0 billion in 2023. Consolidated adjusted operating margins to still exceed 26% by 2026. Gross leverage to still be below 2.0x by mid-year 2023 following strong earnings and cash flow expectations for 2022.

07:08 EDT NuStar Energy sees FY22 net income $193M-$205M - "We expect to generate full-year 2022 net income in the range of $193 to $206 million and full-year 2022 adjusted EBITDA in the range of $700 to $730 million," said Shoaf. He also noted that NuStar now plans to spend $105 to $125 million in strategic capital in 2022. "We still expect to allocate almost $60 million to growing our Permian system and plan to spend about $10 million to expand our West Coast Renewable Fuels Network," said Shoaf. "In addition, we now expect to spend between $30 and $40 million on reliability in 2022."

07:08 EDT Athenex extends cash runway into next year - As of September 30, 2022, the Company had cash and cash equivalents, restricted cash, and short-term investments of $41.4 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

07:07 EDT Peloton falls 14% to $7.45 after Q1 earnings miss

07:06 EDT Athenex announces receipt of positive Nasdaq listing determination - Athenex announced that a Nasdaq Hearings Panel has granted the company's request for continued listing on The Nasdaq Stock Market, subject to the Company's satisfaction of the minimum $1.00 bid price requirement by March 14, 2023. To evidence compliance with the minimum bid price requirement, the Company's common stock must close at or above $1.00 per share for a minimum of 10 consecutive business days by March 14, 2023.

07:05 EDT ConocoPhillips sees Q4 production 1.74-1.80 MMBOED - Fourth-quarter 2022 production is expected to be 1.74 to 1.80 million barrels of oil equivalent per day MMBOED . The company's full-year expected production remains unchanged at 1.74 MMBOED. The company updated its 2022 operating capital guidance to $8.1 billion versus the prior guidance of $7.8 billion, reflecting inflationary impacts and partner-operated well mix in the Lower 48. This guidance excludes $1.7 billion of capital associated with the closed acquisitions of an additional 10% interest in APLNG and bolt-on acquisitions in the Lower 48. Full-year guidance for adjusted operating cost is $7.7 billion versus the prior guidance of $7.5 billion, reflecting inflationary impacts in the Lower 48. Full-year guidance for depreciation, depletion and amortization has decreased from $7.6 billion to $7.5 billion. Full-year guidance for adjusted corporate segment net loss remains at $0.9 billion.

06:59 EDT Hyatt sees FY22 system-wide RevPAR up 60%-65% y/y, down 7%-down 4% vs. 2019 - Sees FY22 net room growth up 6.5% y/y.

06:45 EDT GSK reports EAGLE-2, EAGLE-3 trials for gepotidacin stopped early for efficacy - GSK plc announced that the pivotal phase III EAGLE-2 and EAGLE-3 trials evaluating gepotidacin, an investigational treatment for uncomplicated urinary tract infection, or uUTI, in female adults and adolescents, will stop enrolment early for efficacy following a recommendation by the Independent Data Monitoring Committee, or IDMC. This decision was based on a pre-specified interim analysis of efficacy and safety data in over 3000 patients across the trials. The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure visit for gepotidacin versus nitrofurantoin in patients with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin. The IDMC review did not identify any safety concerns. The EAGLE-2 and 3 trials are now closed for recruitment, with final study visits and data collection anticipated during the first quarter of 2023. GSK will work with regulatory authorities to commence regulatory filings for gepotidacin in H1 2023. The full results will also be submitted for presentation at a scientific congress and for publication in a peer-reviewed journal in 2023. Chris Corsico, SVP, Development, GSK, said: "Uncomplicated urinary tract infections are the most common outpatient infection with over half of all women developing a uUTI during their lifetime and more than a quarter of women suffering from recurrent uUTIs. There has been no new class of oral antibiotics for uUTI for over 20 years. With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary. The IDMC's recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients with uUTIs."

06:33 EDT CommScope still sees FY23 core adjusted EBITDA $1.35B-$1.50B

06:23 EDT Patterson-UTI reports an average of 131 drilling rigs operating in October - Patterson-UTI reported that for the month of October, the company had an average of 131 drilling rigs operating in the United States.

06:22 EDT Tuya receives noncompliance letter from NYSE - Tuya announced that it has received a letter from the New York Stock Exchange dated November 2, notifying Tuya that it is below compliance standards due to the trading price of its American Depositary Shares.

06:21 EDT ING Groep director Mariana Gheorghe decides not to stand for reappointment - ING announced that Mariana Gheorghe has decided not to be available for reappointment to the Supervisory Board at the next General Meeting of Shareholders, in 2023. Mariana Gheorghe was appointed a member of the Supervisory Board at the General Meeting in May 2015 and was reappointed for a second term of four years in 2019. Mariana Gheorghe is a member of the Nomination and Corporate Governance Committee, the Remuneration Committee, Risk Committee and the ESG Committee and will continue in her roles until her current term ends at the General Meeting in 2023. The process of selecting and nominating a candidate for appointment to the Supervisory Board at the 2023 General Meeting is underway.

06:19 EDT ING Groep announces share buyback programme of up to EUR 1.5B - The company said, "ING announced the start of a share buyback programme under which it plans to repurchase ordinary shares of ING Groep N.V., for a maximum total amount of EUR 1.5 billion. The purpose of the share buyback programme is to reduce the share capital of ING. It is a next step in converging our CET1 ratio towards our target of around 12.5% by 2025, as announced during our Investor Update in June 2022. ING Group's CET1 ratio was 14.7% at the end of the third quarter of 2022 which is well above the prevailing CET1 ratio requirement of 10.52%. The buyback programme will have an expected pro-forma impact of roughly 44 bps on our CET1 ratio. The share buyback programme will commence on 3 November 2022 and is expected to end no later than 30 December 2022. Any remaining amount of the programme after the end date will be paid out in cash to shareholders on 16 January 2023."

06:18 EDT X4 Pharmaceuticals Chief Medical Officer, Dr. Diego Cadavid, to depart - X4 announced that its Chief Medical Officer, Dr. Diego Cadavid, intends to depart the company by the end of 2022, but will continue to support X4 as a consultant. Dr. Cadavid, still a practicing neurologist, is leaving to pursue an opportunity that closely aligns with his commitment to patients with intractable CNS disorders. X4 is appointing Dr. Murray Stewart as interim Chief Medical Officer while it conducts a search for a permanent replacement for Dr. Cadavid.

06:15 EDT Watts Water sees Q4 organic growth 5%-8%, adj. operating margin 13.7%-14.2% - Sees "seasonally strong" free cash flow in Q4. Comments taken from Q3 earnings conference call presentation slides.

06:07 EDT LXP Industrial Trust increases quarterly dividend 4.2% to 12.5c per share - LXP declared a regular quarterly common share/unit dividend/distribution for the quarter ending December 31, 2022 of 12.5c per common share/unit payable January 17, 2023 to common shareholders/unitholders of record as of December 30, 2022. This represents an increase of 4.2% from the previous quarterly per share common share/unit dividend/distribution and equates to an annualized increase of 2c per common share/unit and an annualized dividend/distribution of 50c per common share/unit, subject to and assuming future declarations.

05:57 EDT Noble Corp. sees Q4 adjusted EBITDA $155M-$175M - For Q4, Noble announced a guidance range for adjusted EBITDA of $155M to $175M. Capital expenditures are expected to range between $65M and $85M. These estimates reflect the October 3 closing date of the Maersk Drilling business combination and the October 5 sale of five jackups to Shelf Drilling. Commenting on Noble's outlook, Eifler stated, "Our leadership team's extensive worldwide travel to meet with employees and customers in recent weeks has only reinforced our confidence in the talent that we have assembled and the tremendous opportunity at hand for Noble. Despite global macroeconomic uncertainty, the fundamentals in our business, particularly in the deepwater segment, remain very promising, and Noble is poised and ready to execute as a new and dynamic leader in offshore drilling."

05:52 EDT Coinbase Chief Product Officer Surojit Chatterjee to step down - In a regulatory filing, Coinbase said that on October 28, the company and Surojit Chatterjee, the company's Chief Product Officer, mutually agreed that Chatterjee would step down as Chief Product Officer, effective November 30, 2022. Coinbase expects that Chatterjee will continue to serve Coinbase in an advisory role through at least February 3, 2023, it said. "Coinbase is grateful for Mr. Chatterjee's contributions throughout his employment at Coinbase, including his leadership in building Coinbase's product organization and launching products in aim of increasing economic freedom in the world. In connection with Mr. Chatterjee's resignation, Coinbase's product, engineering and design teams are being reorganized within a product group structure under which the leaders of such groups will assume responsibility for Coinbase's product offerings."

05:43 EDT Treasure Global signs MOU with iPay88 Holding for ZCITY App - Treasure Global announced that it has signed a memorandum of understanding with iPay88 Holding, a payment company that offers e-commerce, retail, online banking, e-wallets solutions and more to its merchants in South-East Asia, to become TGI's exclusive payment gateway partner for its proprietary ZCITY App, as well as a partner for TGI's digital food and beverage management platform, Tazte. Under the terms of the agreement, iPay88 will provide e-commerce and retail payment solutions for ZCITY, not only in Malaysia but also additional South-East Asian countries including Indonesia, Thailand and the Philippines, supporting ZCITY's future regional expansion. iPay88 also offers features such as recurring payment solutions and "buy now pay later" which the company has the opportunity to leverage in the future. In addition, partnering with iPay88 provides access to its large F&B merchant list. As part of the agreement, iPay88 will promote Tazte as one of its exclusive collaboration partners prompting F&B merchants to sign up for Tazte as their Manage Software as a Service Solution.

05:33 EDT WISeKey joins forces with Orbus Digital to deploy SSL/TLS services - WISeKey announced that is has joined forces with Orbus Digital to deploy a complete suite of security solutions for organizations' websites based on SSL/TLS services, secured by the OISTE/WISeKey root of trust. GAINDE 2000 Group, an African group in the field of ICTs. Orbus Digital is the branch of the GAINDE 2000 Group that develops a range of products and services to facilitate the administrative procedures and business processes of companies by means of digital solutions. Orbus Digital and WISeKey have signed a strategic partnership agreement aiming to generate synergies by launching new and innovative cryptographic security solutions in the West African region and in other markets.

05:29 EDT ING Groep announces EUR 1.5B share buyback program - ING announced the start of a share buyback program under which it plans to repurchase ordinary shares of ING Groep for a maximum total amount of EUR 1.5B. The purpose of the share buyback program is to reduce the share capital of ING. It is a next step in converging our CET1 ratio towards our target of around 12.5% by 2025, as announced during our Investor Update in June.

05:16 EDT Gogoro announces B2B initiative, partnership with Zypp Electric - Gogoro announced a strategic B2B initiative and partnership with Zypp Electric, India's EV-as-a-Service platform. Together, the companies are focused on accelerating the urban shift of logistics fleets and last mile deliveries to electric using battery swapping. The Gogoro ecosystem offers businesses a path forward that is safe, sustainable, proven and easily scalable. Last mile delivery fleets require a sustainable solution that not only achieves the best alternative to gas-powered vehicles but is well suited to the specific segment needs of the delivery industry. The Gogoro platform delivers the most sophisticated two-wheel battery swapping system that enables delivery operators to manage their fleets and deliveries more efficiently and sustainably. Gogoro expects to launch its B2B pilot with Zypp Electric in Delhi in December and be deployed to multiple fleet operators to support last mile fulfillment, e-commerce, & hyper-local deliveries.