Stockwinners Market Radar for November 11, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:53 EST Cardinal Health announces strategic acquisitions to its portfolio - Cardinal Health (CAH) announced today that it has entered into definitive agreements to acquire two companies that accelerate Cardinal Health's strategic growth areas and that will enhance patient care. The company also provided confirmation of its capital deployment plans. Cardinal Health will acquire a majority stake in GI Alliance, the country's leading gastroenterology management services organization, from a combination of GIA physician owners and funds managed by affiliates of Apollo (APO). Cardinal Health will purchase its majority stake for approximately $2.8 billion in cash, which will represent 71% ownership. GIA will operate as a platform within Cardinal Health's Pharmaceutical and Specialty Solutions segment. Cardinal Health will also acquire the Advanced Diabetes Supply Group (, one of the country's leading diabetic medical supplies providers, for approximately $1.1 billion in cash. ADSG will merge with Cardinal Health's at-Home Solutions business.

20:10 EST Cathie Wood's ARK Investment buys 1.01M shares of PacBio today

19:50 EST Jet.AI Inc trading halted, news pending

18:18 EST Regional Health Properties receives NYSE American notice of delisting - Regional Health Properties announced that, on November 11, 2024, NYSE American LLC publicly announced and provided a notice to the Company that NYSE Regulation has determined to commence proceedings to delist the Company's common stock, no par value, and the Company's Series A Redeemable Preferred Shares, no par value, from NYSE American. The NYSE Regulation has determined that the Company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i) and (ii) of the Company Guide by the end of the maximum 18-month compliance plan period, which expired on November 10, 2024. The Company has a right to a review of the NYSE Regulation determination to delist the Securities by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange. The Company's request for such a review must be made by November 18, 2024. The Company intends to appeal such determination. The Company expects the Securities to continue to trade on NYSE American during the appeal process.

17:37 EST Teradyne increases share repurchase plan for 2024 - Teradyne plans to repurchase up to an additional $100M of its common stock in the remainder of 2024 as part of its previously announced $2B share repurchase program. This is an increase from its previously announced intention to repurchase common stock in an amount necessary to offset dilution from equity compensation and its employee share repurchase program.

17:15 EST Enstar Group enters into ADC agreement with James River Group - Enstar Group (ESGR) has entered into an adverse development cover, or ADC, reinsurance agreement with certain subsidiaries of James River Group (JRVR). An Enstar subsidiary will provide $75M of limit in excess of the existing $160M ADC reinsurance coverage provided to such subsidiaries of James River by State National Insurance earlier this year. The transaction will provide further protection against future adverse reserve development for certain U.S. casualty exposures within James River's Excess & Surplus Lines segment for accident years 2010 to 2023. Enstar's subsidiary will also make a $12.5M investment in James River common stock. Completion of the transaction is subject to regulatory approval and satisfaction of other customary closing conditions.

17:05 EST IAC exploring spinoff of 85% ownership in Angi to shareholders - IAC (IAC) said in a letter to shareholders: "We are again at one of those inflection points, and here's what we plan to do: We are exploring a spinoff of our 85% ownership in Angi (ANGI) to IAC shareholders, which would make Angi the 10th fully standalone public company to come from IAC; We have decided to report Care.com as a separate segment in our financials beginning with the fourth quarter of 2024 to showcase the earnings of the leading consumer marketplace for care - in the last twelve months, that was $46 million of Adjusted EBITDA; In the event of an Angi spin, we will be a smaller IAC, and our corporate costs will need to reflect that. We'll be reviewing corporate costs with an Angi spin-off in mind; We will opportunistically analyze strategic sales of IAC businesses to simplify IAC and free up capital for better value creation, with the expectation that Dotdash Meredith ("DDM") and MGM would comprise the core of IAC should an Angi spin occur; and We will continue to actively evaluate new areas to deploy our capital, but attractively valued assets are not easy to acquire in this current market environment. We remain patient for the right opportunity, and the bar on new acquisitions remains high. Of course, the most significant step outlined above, though perhaps not the most surprising, is the potential separation of Angi from IAC. In a consistent pattern of anti-conglomerating, Angi would join a long list of businesses built up over time and spun off by IAC. Strategically, operationally, and financially, Angi is now ready to stand separately with a more liquid equity currency and the ambition to win, while IAC continues to simplify and focus. I deeply believe in the breakout potential of the Angi business, and, while we haven't yet delivered it durably inside of IAC, our shareholders would be able to participate directly in Angi's bright future on its own. Plus, with increased liquidity in the stock, we expect Angi to have a more attractive currency to optimize its business - whether for category consolidation, capital formation, or employee compensation."

16:45 EST Intevac says will enter restructuring, reduce headcount by 19% - Comments taken from Q3 earnings conference call.

16:35 EST Investors Title Company declares special cash dividend of $14 per share - The dividend is payable to shareholders of record on December 2, 2024, payable December 16, 2024.

16:31 EST Victory Capital reports October-end AUM $172.3B - Victory Capital "reported total assets under management of $172.3B, other assets of $4.2B, and Total Client Assets of $176.5B, as of October 31, 2024. For the month of October, average Total AUM was $175.0B, average Other Assets was $4.6B, and average Total Client Assets was $179.6B."

16:25 EST Cohen & Steers reports preliminary AUM of $89.7B as of October 31 - Cohen & Steers reported preliminary assets under management of $89.7B as of October 31, a decrease of $2B from assets under management of $91.8B at September 30. The decrease was due to market depreciation of $2.3B and distributions of $150M, partially offset by net inflows of $454M.

16:18 EST Strattec Security names Matthew Pauli CFO - Strattec Security announced the Board of Directors of STRATTEC has appointed Matthew Pauli as Senior Vice President, Chief Financial Officer effective November 13, 2024. He will succeed Dennis Bowe, who will be continuing with the Company in an advisory role to aid in the transition. Jennifer Slater, STRATTEC President and CEO, noted, "We are in the midst of a transformation that requires deep financial experience and capabilities related to operational change, data analytics and information systems. Given the level of experience essential to execute our transformation, the Company needs operational financial proficiency with implementing tools and oversight processes to create the focus and consistency requisite for achieving more predictable financial outcomes. Dennis has been great support for me and the organization as we have managed through the early stages of change, and we are very grateful that he will continue to support us through this transition."

16:16 EST Invesco reports preliminary AUM $1.77T as of October 31 - Invesco reported preliminary month-end assets under management of $1.772T, a decrease of 1.3% versus previous month-end. The firm delivered net long-term inflows of $2B in the month.

16:11 EST Zeta Global up 8% at $39.71 after Q3 results, raised guidance

16:09 EST Domo select by Bond Vet for global data technology services - Domo announced that Bond Vet, a full-service veterinary clinic offering primary care, wellness services, surgical procedures and urgent care for pets, has selected Domo as its global data technology platform. This collaboration underscores Bond Vet's strategy of combining compassionate, high-quality veterinary care with the latest advancements in technology and operational efficiency. By integrating innovative and automated solutions, the practice can dedicate more time to caring for pets and pet parents, improving patient outcomes and client experiences. "We are excited to partner with Domo," said Joe Altobelli, Bond Vet's Chief Financial Officer. "With the rapid growth of data in today's business landscape, Bond Vet recognizes the critical need for powerful data analysis capabilities. Domo integrates advanced and predictive analytics, machine learning and real-time data processing to provide actionable insights that empower teams to make data-driven decisions with greater speed and accuracy."

16:09 EST LivaNova announces OSPREY clinical study meets safety/efficacy endpoints - LivaNova "announced that it met the primary endpoints for its OSPREY randomized controlled trial, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation. Together with its safety endpoints, the RCT achieved statistical significance of its primary endpoint responder rates1,2 between the treatment arm and the sham arm for the LivaNova aura6000(TM) System. The aura6000 is an implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea. In the OSPREY study, apnea-hypopnea index and oxygen desaturation index (ODI) reductions are analyzed as part of the study's secondary endpoints. Comparing median values from baseline to six months with therapy (assessed at the seven-month follow-up visit), OSPREY subjects in the device stimulation group experienced significant reductions in these endpoints as follows: AHI reduced by 66.2% when the median at baseline of 34.3 is compared to the median of 11.6 at six months. ODI reduced by 63.3% when the median at baseline of 34.9 is compared to the median of 12.8 at six months. Once the six-month results analysis is completed, LivaNova will submit the OSPREY clinical data to the U.S. Food and Drug Administration as part of its premarket approval submission for the aura6000 System."

16:02 EST Arcturus Therapeutics receives FDA clearance to begin H5N1 vaccine trial - Arcturus Therapeutics Holdings announced that the U.S. Food and Drug Administration has issued a "Study Can Proceed" notification for the Company's Investigational New Drug application, ARCT-2304, a self-amplifying mRNA vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority and designed to enroll approximately 200 healthy adults in the United States. "Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR self-amplifying mRNA technology is a key step in this important process," said Joseph Payne, President & CEO of Arcturus Therapeutics. "The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza."

16:01 EST Neurogene reports 'positive' interim efficacy data from NGN-401 participants - Neurogene announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase 1/2 open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. Low-dose NGN-401 has demonstrated a favorable safety profile. "Today marks an important day for Neurogene and the Rett syndrome community as we share positive interim data for NGN-401 from our low-dose cohort that shows the first four participants demonstrated meaningful gains of skills and developmental milestones in core clinical domains of Rett syndrome, which are not expected to occur when compared to and contextualized against the natural history of Rett syndrome. Data were also concordant across multiple scales and show consistency of effect across patients, despite their unique clinical presentations at baseline," said Rachel McMinn, Ph.D., Founder and Chief Executive Officer of Neurogene. "We are incredibly thankful to the participants, caregivers and Rett syndrome trial sites who are participating in our study." "Rett syndrome is a devastating neurodevelopmental disease that is incredibly challenging for patients and their caregivers given there are no treatment options available to address the underlying cause of the disease," said Aleksandra Jacobs, M.D., Ph.D., Professor of Pediatric Neurology, Albert Einstein College of Medicine and Director of the Center for Rett Syndrome in the Children's Hospital at Montefiore Medical Center. "The totality of the outcomes shared today with NGN-401 gene therapy have never been seen before in the treatment of Rett syndrome. Notably, these initial participants acquired developmental skills post-treatment during the period in which the natural history of Rett syndrome indicates girls would not. I look forward to the continued progress in this program and additional data to come."

14:41 EST Altimmune says pemvidutide given 'clean safety bill of health' by FDA - At the Guggenheim Securities Healthcare Innovation Conference, Altimunne said earlier: "So the first thing is that survodutide has a ratio of GLP-1/glucagon of 8 to 1. It's much more heavily biased to GLP one, we're 1 to 1, which means that we have more glucagon potency. So if you believe in glucagon and its effects on liver fat and lipids, we're a preferred molecule. We actually beat Survodutide on their weight loss at 48 weeks, given the same statistical analysis. And in addition, we're much better tolerated there. Adverse event discontinuations were in excess of 20% or all of their doses approaching 30%. In fact, that one study presented at the liver meetings 47% adverse event discontinuation rates, and now they're announcing titration out to 24 to 32 weeks, whereas we can achieve better than that with a much more limited dose titration. I think it's also important to realize that we were given a safety bill, clean safety bill of health by the FDA. If you look at the Survodutide Phase three program, we actually have a safety study in there that's powered to show non-inferiority to placebo. Sorry for the statistical terms to show no harm greater than placebo, and that's very unusual... So that's a bit strange. It hasn't been enforced in any of the other sponsors. They mentioned in a recent publication that glucagon could have cardiotoxic effects So this is a reasonable study to do. We're speculating that there might be something there that raised the attention of the agency. We don't know for certain. But I would say flipping back to Pemvidutide is that we were given a very good clean a very clean bill of health by the agency. As we mentioned before our studies are all efficacy studies. They're not safety studies. We weren't asked to do one by the agency." Survodutide is a drug being developed by Boehringer Ingelheim to treat obesity and metabolic dysfunction-associated steatohepatitis, or MASH.

12:32 EST Chipotle appoints Scott Boatwright as CEO - Chipotle Mexican Grill's Board of Directors has appointed Scott Boatwright as CEO and a member of the board, effective immediately. Prior to being named Interim CEO in August, Boatwright served as COO, reporting directly to the company's CEO since 2017. Prior to Chipotle, Boatwright spent 18 years with Arby's Restaurant Group in various leadership positions.

12:02 EST Virgin Galactic rises 23.0% - Virgin Galactic is up 23.0%, or $1.43 to $7.65.

12:02 EST Finance of America rises 33.4% - Finance of America is up 33.4%, or $5.32 to $21.23.

12:01 EST Trimble says SketchUp surpasses 1M active subscribers - Trimble announced that its SketchUp 3D modeling software surpassed one million active subscribers. The announcement was made at Trimble Dimensions User Conference and 3D Basecamp. "We've found the subscription business model allows us to consistently deliver new features, services and integrations that empower our AEC customers to communicate design ideas better and work more efficiently and collaboratively with all stakeholders on a construction project," said Christopher Cronin, VP & GM, architecture, design and education at Trimble SketchUp. "The response from our customers to the lower up-front investment, reliable budgeting and consistent delivery of visualization, collaboration, interoperability and now, AI enhancements, have been key to us surpassing this milestone."

12:00 EST Valhi falls -22.4% - Valhi is down -22.4%, or -$9.24 to $32.06.

11:25 EST Houston American Energy trading resumes

11:14 EST Apple's Find My now sharable with third parties - Apple (AAPL) has introduced Share Item Location, a new iOS feature that helps users locate and recover misplaced items by easily and securely sharing the location of an AirTag or Find My network accessory with third parties such as airlines. Share Item Location is available now in most regions worldwide as part of the public beta of iOS 18.2, which will soon be available to all users as a free software update for iPhone Xs and later. Find My is built with privacy and safety at its core. The shared location will be disabled as soon as a user is reunited with their item, can be stopped by the owner at any time, and will automatically expire after seven days. Users can generate a Share Item Location link in the Find My app on their iPhone, iPad, or Mac. Recipients of a link will be able to view a website that shows a location of the item on an interactive map. The website will automatically update when a new location is available and will show a timestamp of the most recent update. In the coming months, more than 15 airlines serving millions of people globally - including Aer Lingus, Air Canada (ACDVF), Air New Zealand (ANZFF), Austrian Airlines, British Airways, Brussels Airlines, Delta Air Lines (DAL), Eurowings, Iberia, KLM Royal Dutch Airlines (AFLYY), Lufthansa (DLAKY), Qantas (QABSY), Singapore Airlines (SINGF), Swiss International Air Lines, Turkish Airlines, United (UAL), Virgin Atlantic, and Vueling - will begin accepting Find My item locations as part of their customer service process for locating mishandled or delayed bags. More airlines will be added over time.Reference Link

10:49 EST Houston American Energy trading halted, news pending

10:00 EST Ouster rises 17.5% - Ouster is up 17.5%, or $1.40 to $9.39.

10:00 EST Cango rises 17.9% - Cango is up 17.9%, or 61c to $4.01.

10:00 EST ProShares UltraShort Bloomberg Natural Gas falls -16.4% - ProShares UltraShort Bloomberg Natural Gas is down -16.4%, or -$13.61 to $69.20.

09:50 EST FDA grants Sonoma 510(k) approval for Microdacyn Hydrogel - The FDA posted online 510(k) approval for Sonoma Pharmaceuticals' Microdacyn Hydrogel, which is intended for use of acute and chronic wounds, ulcers, cuts, abrasions and burns healing. Reference Link

09:48 EST Bristol Myers rises 11.6% - Bristol Myers is up 11.6%, or $6.29 to $60.43.

09:48 EST Cango rises 17.9% - Cango is up 17.9%, or 61c to $4.01.

09:48 EST FutureFuel falls -13.8% - FutureFuel is down -13.8%, or -84c to $5.25.

09:47 EST ProShares UltraShort Bloomberg Natural Gas falls -15.1% - ProShares UltraShort Bloomberg Natural Gas is down -15.1%, or -$12.53 to $70.28.

09:44 EST DESTINY TECH100 INC trading halted, volatility trading pause

09:42 EST Total Wireless partners with Puerto Rican boxer Amanda Serrano - Total Wireless announced its official partnership with Puerto Rico's boxing trailblazer and unified featherweight champion Amanda Serrano and Most Valuable Promotions. Serrano, who has never owned a cell phone due to her commitment and focus on boxing, has now at age 36 received her first-ever phone. With an unlimited data plan that will never slow her down, she can stay connected while still honing in on her career. As part of its partnership with Most Valuable Promotions, Total Wireless will join MVP Uncut, the company's evergreen docuseries following MVP talent behind the scenes as they prepare for Paul vs. Tyson and Taylor vs. Serrano 2. On Tuesday, November 12, MVP Uncut will capture Serrano receiving her first-ever phone at a local Total Wireless store.

09:39 EST Engine Capital responds to Dye & Durham's recent efforts 'to entrench itself' - Engine Capital, which owns approximately 7.1% of the issued and outstanding common shares of Dye & Durham issued the following statement regarding the Board of Directors' "recent efforts to entrench itself and disenfranchise shareholders": "Chair Colleen Moorehead and her Board's actions indicate that they will go to great lengths to maintain power and prevent shareholders from having their voices heard. After pursuing a requisitioned shareholder meeting to refresh the Board for over eight months, Engine received a letter from Company counsel late Friday raising baseless concerns regarding our director nomination notice for the upcoming Annual Meeting and seeking additional superfluous information. Dye & Durham continues to baselessly claim that Engine is part of a shareholder group - a false assertion that's been obsessively peddled by Ms. Moorehead and CEO Matt Proud for months now. Despite these transparent entrenchment efforts, Engine intends to comply with the information requests and urges the Board to immediately cease its gamesmanship and commit to providing shareholders the opportunity to vote for our world-class slate at the December Annual Meeting. If the Board invalidates our nomination, Engine will be forced to take legal action against the Company, which would only waste additional shareholder capital and potentially delay the Annual Meeting. We suspect this is Ms. Moorehead and Mr. Proud's ultimate goal and cannot permit this precedent of weaponizing the corporate machinery. This latest defense tactic follows the Board's attempts to use a Competition Bureau investigation into Dye & Durham to convince the Court that current management and the Board should stay in power. Ironically, Mr. Proud and the Board's own mismanagement - as evidenced by the stunning admission in Court documents that eight out of 11 direct reports of Mr. Proud recently departed - is what seemingly put Dye & Durham in the crosshairs of the Competition Bureau in the first place. Under the Board's oversight, nearly the entire senior management team reporting to Mr. Proud has exited the Company, Canadian regulators have launched an investigation, two deals in the U.K. and Australia were blocked by regulators, shareholder feedback has been ignored for years and customers have grown increasingly aggravated. Finally, given Ms. Moorehead's history of self-preservation tactics, we caution the Board against resorting to further entrenchment maneuvers before the upcoming shareholder vote, including self-refreshment. The Company's directors should not hand-pick their successors given their track record of poor performance and anti-shareholder governance. Shareholders have the right to elect a new Board composed of independent and experienced directors whose sole focus will be creating long-term shareholder value."

09:31 EST Xiao-I announces strategic agreement with Hong Kong public sector client - Xiao-I announced a strategic agreement with an undisclosed Hong Kong public sector client. This engagement further solidifies Xiao-I's reputation and expands its footprint in the Hong Kong public sector, and is projected to generate initial revenue of approximately 8M Hong Kong dollars. Through this collaboration, Xiao-I will leverage its proprietary HuaZang Large Language Model as the foundational model, with Chatbot application, to enhance the client's existing HR operations, enabling an AI-driven transformation of their internal workflows.

09:30 EST Aligos Therapeutics trading halted, volatility trading pause

09:17 EST Nisun International acquires minority stake in KFC franchisee - Nisun International acquired a minority stake in Nanjing Pin Bai Sheng Catering, a franchisee and partner in China's food and beverage sector. Nanjing Pin Bai Sheng provides catering services across educational institutions, government agencies, and corporate settings. In the coming years, the two companies plan to expand to over 200 campus locations.

09:09 EST AMN Healthcare approves near, long-term emissions reduction targets - AMN Healthcare announces it has approved near and long-term science-based emissions reduction targets with the Science Based Targets initiative, SBTi, joining over 4,000 companies globally in the pursuit of net zero emissions. This decisive move underscores AMN Healthcare's dedication to sustainability and proactive measures against climate change.

09:07 EST Longeveron appoints Blass as Chief Technology Officer - Longeveron announced that it has appointed Devin Blass as Chief Technology Officer, CTO, and Senior Vice President of Chemistry, Manufacturing, and Controls, CMC, effective December 2, 2024. In this role, he will lead the Company's technological and manufacturing strategies.

09:07 EST BackCountry chooses Sezzle for payment solution - Sezzle announced a new partnership with Backcountry. Customers will soon be able to take advantage of Sezzle flexible financing, across all of Backcountry's online and in-store brands, including Steep & Cheap, Competitive Cyclist, and MotoSport. Backcountry's decision to switch from a competing BNPL provider to Sezzle was influenced by several key factors, with the Sezzle product's superior approval rates being a standout advantage. The Sezzle platform's ability to approve a wider range of customer profiles aligns with Backcountry's commitment to inclusivity and customer satisfaction. This approval efficacy highlights Sezzle's strength in serving diverse customer needs, including those who may have been impacted by the debt cycles of traditional credit institutions. This key differentiator made Sezzle the clear choice for Backcountry.

09:06 EST Children's Place appoints Ende as GVP, Head of Real Estate - The Children's Place announced that Philip Ende has been appointed GVP, Head of Real Estate, effective November 11, 2024. As the Head of Real Estate, Ende will oversee the real estate strategy and operations for the Company. He will report to Muhammad Umair, President and Interim Chief Executive Officer.

09:05 EST Latham Group to unveil new line of plunge pools - At this week's International Pool, Spa, & Patio Expo in Dallas, Latham Group will unveil a new line of plunge pools designed to bring leisure and luxury to backyards of any size. From the only brand to offer both fiberglass and vinyl liner options, the curated collection includes six designs perfect for homeowners seeking a sleek, elegant pool that fits seamlessly into any outdoor space. Blending form with function, Latham Plunge Pools provide practical and stylish solutions that are ideal for compact yards but also add a luxurious touch to larger spaces as well. These fun-sized pools offer full-sized fun with greater convenience, faster and more affordable installation, energy efficiency, and easy maintenance with less chemical usage.

09:04 EST BCP partners with Microsoft, Kyndryl on IT infrastructure update - Banco de Credito del Peru has partnered with Microsoft (MSFT) and Kyndryl (KD) to modernize BCP's IT systems with hybrid cloud and help Peruvians gain greater access to digital banking services. This agreement represents BCP's investment of more than $650M over five years, making it one of the largest technology investments in Latin America's financial services sector.

09:02 EST Instacart says local, independent grocers adopt Instacart Caper Carts - Instacart announced that multiple local and independent grocers, including Bowman's Market, Maurer's Market IGA, Neiman's Family Market, Queen's Price Chopper and Soelbergs Market are adopting Caper Carts, Instacart's AI-powered smart carts, across their stores. This move signifies a growing trend among independent grocers to embrace and integrate technology that enhances and makes the grocery shopping experience more delightful for their customers.

08:51 EST Citius Pharmaceuticals, Citius Oncology report promising cancer trial results - Citius Pharmaceuticals (CTXR) and Citius Oncology (CTOR) announced "promising" preliminary results from an ongoing investigator-initiated Phase I clinical trial evaluating the safety and efficacy of a combined regimen of pembrolizumab and lymphir in patients with recurrent solid tumors. The trial aims to identify an optimal dose for future trials and explore the impact of a treatment regimen combining pembrolizumab and lymphir on the tumor immune microenvironment. Pembrolizumab, developed by Merck (MRK) and sold under the brand name keytruda, is the leading PD-1 inhibitor. The results of this chemotherapy-free regimen combining two immuno-modulator agents, pembrolizumab and lymphir demonstrated: an overall response rate of 27% - 4/15 - and a clinical benefit rate of 33% among evaluable patients; and median progression-free survival for patients achieving clinical benefit of 57 weeks. Two of the four patients who achieved partial remission had received prior checkpoint inhibitors. The trial enrolled 21 patients with recurrent or metastatic solid tumors. Among the evaluable participants, four patients achieved a partial response, and one patient demonstrated durable stable disease lasting over six months. The combination regimen was generally well tolerated, with most adverse events related to the patients' underlying disease. No significant immune-related adverse events were observed.

08:43 EST Aptevo announces ALG.APV-527 meets trial endpoints in Phase 1 study - Aptevo Therapeutics and Alligator Bioscience announced preliminary data from the companies' Phase 1 trial evaluating the first-in-class bispecific antibody, ALG.APV-527, as monotherapy for the treatment of multiple solid tumor types likely to express tumor antigen 5T4. These data indicate that trial endpoints of adequate exposure, safety, tolerability and biological activity were met. Outcomes were presented at a poster session on Friday November 8, 2024, at the Society for Immunotherapy of Cancer Conference in Houston, Texas. "The interim results from Phase 1 trials of ALG.APV-527 are showing encouraging outcomes, particularly in terms of safety and disease stability in the trial patients who were refractory to multiple previous therapies. Among evaluable patients, 56% (9/16) achieved stable disease in this monotherapy trial. A colon cancer patient remained on study with stable disease for more than six months as well as a breast cancer patient who remained stable for over 11 months. Importantly, there were no instances of serious liver toxicity, a notable outcome given the relatively high incidence of this side effect associated with other treatments targeting 4-1BB. By leveraging a novel bispecific approach, ALG.APV-527 aims to enhance anti-tumor immunity while avoiding the systemic toxicities that previously have hampered the 4-1BB immune receptor pathway. These findings underscore the drug's potential as a viable option for patients with solid tumors," noted Dr. Thomas Marron, MD, PhD, Professor of Immunology & Immunotherapy and Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, and a leading investigator in the trial. Clinical Highlights: Safety and Tolerability: ALG.APV-527 demonstrated positive safety and tolerability across all cohorts; No serious liver toxicity, a common side effect of other 4-1BB targeting treatments that can cause patients to discontinue dosing, was observed; A maximum tolerated dose has not been identified, highlighting the tolerability of the drug at high dose levels. Clinical Activity/Efficacy: Nine of 16 efficacy evaluable patients achieved stable disease; One colon cancer patient achieved SD for more than six months; The longest SD duration was in a breast cancer patient who entered the study with progressive disease, achieved stable disease and remained on study for greater than11 months. This patient successfully transitioned to a higher dose level twice. Evidence of biological activity of ALG.APV-527: ALG.APV-527 could be measured in all patients. Serum concentrations of ALG.APV-527 were proportional to the administered dose; Analysis of biomarkers in the serum of treated patients including soluble 4-1BB confirm biological activity of ALG.APV-527; Analysis of biomarkers in biopsies. This observation consistent with ALG.APV-527 expected MOA.

08:39 EST Clean Harbors raises Safety-Kleen used oil price and service stop fees - Clean Harbor announced that its Safety-Kleen subsidiary is revising pricing related to collecting and managing used engine and industrial oils. Effective immediately, the Company will be targeting a broad range of rate changes across its used oil customer base...."These rate changes are needed for Safety-Kleen to continue to perform and be appropriately compensated for the safe, compliant and reliable waste oil collection services we provide to more than 100,000 customers across North America annually," Weber concluded.

08:38 EST Dominari Holdings appoints Kyle Degruttola as controller - Dominari Holdings has appointed Edward Deignan as Vice President of Finance and Accounting and Kyle Degruttola as Controller. Deignan is responsible for the day-to-day management of the Company's financial operations. He brings with him more than 30 years of experience in accounting, finance and banking. He has served as a CFO for several companies over the past decade. Degruttola is responsible for directing all accounting operations. He brings with him more than 20 years of experience in accounting and finance, including serving as a collegiate professor of accounting and computer science at Wood Tobe-Coburn College and Union County College. Most recently, he served as Controller for the City of Jersey City.

08:37 EST Ainos announces IRB approval for Sjogren's Syndrome clinical study - Ainos has received Institutional Review Board approval from Shuang Ho Hospital, affiliated with Taipei Medical University, for its clinical trial of VELDONA in treating Sjogren's syndrome. Ainos plans to commence a site initiation visit for the study around April 2025, subject to regulatory approvals. The study aims to further assess the potential of VELDONA in improving salivary gland function and alleviating symptoms of dryness. Ainos previously conducted eight clinical studies in the U.S., including three Phase 3 trials, showing that VELDONA significantly increases unstimulated whole salivary flow.The study will be conducted at Shuang Ho Hospital under the oversight of the Department of Allergy, Immunology, and Rheumatology. Its primary endpoint is to evaluate the efficacy of VELDONA in improving salivary flow and alleviating dryness symptoms in patients with primary Sjogren's syndrome. The trial follows an open-label design and will recruit 24 patients for a 24- to 48-week treatment period, based on the diagnostic criteria established by the American and European Rheumatology Associations in 2016. Secondary endpoints include: Assessing improvements in dryness symptoms using the European League Against Rheumatism Sjogren's Syndrome Patient Reported Index; Measuring changes in disease activity using the EULAR Sjogren's Syndrome Disease Activity Index; Evaluating eight specific dryness symptoms, including oral and ocular dryness, using the Visual Analog Scale; Conducting nuclear medicine imaging to compare pre- and post-treatment salivary gland function. The trial is managed by ComboTrial Consultancy Ltd. under Good Clinical Practice standards. Following the IRB approval from Shuang Ho Hospital, Ainos plans to submit to Taiwan's Food and Drug Administration by the end of December 2024 and anticipates to complete all approvals by Q1 2025, with the SIV scheduling for April 2025. Patient recruitment will span six months, with the First Patient First Visit anticipated for May 2025, the Last Patient Last Visit by the end of November 2025, and study completion by the end of December 2026.

08:36 EST Banzai regains compliance with Nasdaq minimum market value - Banzai International announced that it has received notice from The Nasdaq Stock Market informing the Company that it has regained compliance with the minimum market value of publicly held shares, MVPHS, requirement under Nasdaq Listing Rule 5550(a)(5) for continued listing.

08:33 EST ReShape Lifesciences receives NIH supplementary grant with CARSS - ReShape Lifesciences announced that the Company was awarded an approximately $241,000 supplementary grant from the National Institutes of Health, NIH, with the University of Southern California's Center for Autonomic Nerve Recording and Stimulation Systems, CARSS, for the development of the next-generation electrodes for ReShape's Diabetes Bloc-Stim Neuromodulation, DBSN, device. The DBSN utilizes its proprietary vagus nerve block technology platform, combined with vagus nerve stimulation, for the treatment of Type 2 diabetes, a prominent disorder associated with obesity. The supplementary grant will be utilized to conduct minimally invasive laparoscopic surgical electrode implantation techniques as well as long duration safety and blood glucose modulation experiments in a porcine model of diabetes.

08:32 EST MARA adds 372 megawatts of capacity in Ohio - MARA announced the addition of approximately 372 megawatts of owned and operated compute capacity across three sites in Ohio. These additions include the acquisition of two data centers offering a combined 222 megawatts of interconnect-approved capacity and the development of a third, greenfield data center, which is expected to add 150 megawatts of compute capacity upon completion. On November 5, 2024, MARA acquired the two operational data centers in Hannibal and Hopedale, Ohio, with 222 megawatts of interconnect-approved capacity. These sites have 122 megawatts of capacity and interconnection approval to expand by another 100 megawatts. Simultaneously, MARA has begun developing a 150-megawatt operation in Findlay, Ohio, which already has 30 megawatts of capacity. These three facilities have a combined interconnect-approved capacity of 372 megawatts, which MARA intends to fully energize by the end of 2025. Compute for these sites is purchased, secured, and ready for deployment, and the Company believes these sites will accelerate MARA's achievement of its 2024 target of 50 EH/s. "Through MARA's proven discipline and data center expertise, we acquired these assets at a multiple of approximately $270,000 per megawatt, based on approved capacity and after customary adjustments," said Salman Khan, CFO. "This is one of the lowest disclosed multiples amongst our larger publicly traded peers and demonstrates our unmatched ability to deliver accretive acquisitions. Furthermore, these data centers will increase our total owned and operated compute capacity by over 70 percent. Owning the sites will provide us with greater operational control and could further reduce our operating costs at the Hopedale data center-previously hosted by the former owner-by up to 50 percent. Much of the future capacity is alongside operating generation, providing opportunities for cost reduction, power redundancy, and development optionality."

08:31 EST Strata Skin announces favorable court order in complaint against LaserOptek - STRATA Skin Sciences announces that the United States District Court for the Eastern District of Pennsylvania entered a court order in favor of the Company in its complaint against LaserOptek America, Monarch Aesthetic Services, Inc. d/b/a Monarch Laser Services, and The Pinnacle Health Group, collectively referred to as the "Defendants." On August 19, 2024, STRATA filed a Complaint and a Motion for a Preliminary Injunction against the Defendants, citing unfair competition under federal and state laws regarding the marketing and sales of LaserOptek's Pallas lasers in the United States. On November 8, 2024, the United States District Court for the Eastern District of Pennsylvania entered a court order pursuant to which: LaserOptek and The Pinnacle Health Group, their employees, agents, sales representatives, distributors, officers, directors, and all those acting at their direction are enjoined from engaging in any sales, advertising, marketing or promotion of Pallas lasers that states or implies, directly or indirectly, that treatments with Pallas laser systems are reimbursable using CPT Codes 96920-96922; and LaserOptek and The Pinnacle Health Group, their employees, agents, sales representatives, distributors, officers, directors, and all those acting at their direction are further barred from engaging in any sales, advertising, marketing or promotion of Pallas lasers in the United States that includes any false or misleading statements regarding the Pallas lasers or STRATA's lasers

08:28 EST The Oncology Institute gets certification to administer Pluvicto in California - The Oncology Institute have received certification to begin administering Pluvicto therapy in their outpatient California radiation oncology practices. Pluvicto, a radiopharmaceutical used to treat certain types of metastatic prostate cancer, has previously been administered primarily in hospital settings.

08:27 EST Nano Labs starts accepting payments in Bitcoin - Nano Labs announced that the Company has set up a Coinbase account and starts accepting payments in Bitcoin in exchange for its products. This strategic move marks the Company's commitment to embracing the latest in financial technology and enhancing its global transaction capabilities.

08:26 EST Indaptus Therapeutics publishes research in Frontiers in Immunology - Indaptus Therapeutics announced that Dr. Michael Newman, Founder and Chief Scientific Officer, has published his research in the peer-reviewed journal, Frontiers in Immunology. The article, titled "Invention and Characterization of a Systemically Administered, Attenuated and Killed Bacteria-Based Multiple Immune Receptor Agonist for Antitumor Immunotherapy," presents the Company's innovative approach to activating both the innate and adaptive sides of the immune system to treat cancer. The paper is being published as part of a Research Topic on The Vital Role of Innate Immunity in Cancer Immunotherapy. Key Highlights from the Research: Multi-Pathway Immune Activation; Encouraging Preclinical Data; Reduced Toxicity Profile

08:25 EST Nexalin Technology releases letter to shareholders - Nexalin Technology released a letter to shareholders from its CEO Mark White: "I am pleased to provide an update on Nexalin Technologies' recent milestones, which underscore our commitment to advancing our patented Deep Intracranial Frequency Stimulation, DIFS, technology for the treatment of neurological and mental health conditions... Our Alzheimer's research achieved an important breakthrough, with two significant studies published this October. On October 17, we announced the results of a new study using our DIFS technology, which demonstrated substantial improvements in memory and cognitive function for Alzheimer's patients... Furthermore, our October 28 press release highlighted a second publication in the Journal of Alzheimer's Disease, reinforcing our prior study and validating DIFS as a promising therapy for cognitive decline... Nexalin's DIFS technology has shown promising results beyond Alzheimer's, notably in treating Major Depressive Disorder ... Expanding our clinical reach, we recently announced a collaboration with the University of California, San Diego and the San Diego VA to conduct a clinical trial using Nexalin's Gen-3 Halo headset, designed to be used in a virtual clinic model and allowing patients to receive treatment from the convenience and privacy of their own home... Aligned with our mission to make Nexalin's innovative technology widely accessible, we are pursuing regulatory pathways to expand DIFS's approved uses, including Alzheimer's, MDD, PTSD, mTBI, and more. As we engage with regulatory agencies around the world, these approvals will be key to making safe and effective neurostimulation available for more patients globally... The recent Alzheimer's studies, positive MDD data, UC San Diego and San Diego VA clinical trial, patent award, and regulatory clearance in Brazil are all significant milestones in Nexalin's journey. Together, they reflect our commitment to providing safe, effective, and non-invasive solutions for those impacted by cognitive and mental health challenges."

08:22 EST CG Oncology announces publication in Nature Medicine of Phase 1b results - CG Oncology announced the publication in Nature Medicine of Phase 1b investigator-sponsored study results evaluating intravesical cretostimogene grenadenorepvec in combination with Bristol Myers Squibb's immune checkpoint inhibitor nivolumab, in muscle-invasive bladder cancer, MIBC. The publication is now available online and will be in a future print edition of Nature Medicine. The results were also presented at the Society for Immunotherapy of Cancer, SITC, 2024 by Dr. Roger Li, M.D., urologic oncologist at Moffitt Cancer Center.

08:20 EST LPL Financial: Nexus Wealth joins LPL's broker-dealer, RIA, custodial platforms - LPL Financial LLC, announced today that the financial advisors at Nexus Wealth Partners have joined LPL Financial's broker-dealer, RIA and custodial platforms. They reported serving approximately $410 million in advisory, brokerage and retirement plan assets, and they join LPL from Osaic. Based in Westlake Village, Calif., the team is led by managing partners Scott D. Nelson, and Kamie Abraham, and includes four support staff members. For 18 years, Nelson has assisted business owners, corporate executives, retirees and wealthy multigenerational families make informed decisions while accumulating and preserving their wealth. He also manages the entertainment industry wing of Nexus Wealth Partners, where he serves several award-winning actors, writers, sound engineers and Hollywood executives. Abraham brings over 10 years of experience to the team and specializes in helping women in life transitions, families and retirees develop and implement personalized strategies as they work toward their financial goals with confidence.

08:18 EST Vera Therapeutics partners with University of Michigan on NEPTUNE match project - Vera Therapeutics is partnering with the University of Michigan on the Nephrotic Syndrome Study Network, NEPTUNE, Match project. NEPTUNE is a multicenter consortium of more than 30 North American academic centers that conducts clinical and translational research on kidney diseases that present as nephrotic syndrome. Through NEPTUNE Match, participants and their nephrologists receive information about clinical trials targeting mechanisms that match the participant's molecular disease characteristics. In partnership with Vera Therapeutics, NEPTUNE Match will inform potential participants about the PIONEER study.

08:16 EST Sub Pop Records announces campaign with Barnes & Noble - Sub Pop Records, in conjunction with AMPED Distribution, announces a major campaign with Barnes & Noble that began October 2, 2024, and is running through January 5, 2025. The campaign features six Sub Pop limited edition color variant vinyl LPs that are sold exclusively at Barnes & Noble stores. Exclusive titles include Suki Waterhouse Memoir Of A Sparklemuffin, Father John Misty Greatish Hits: I Followed My Dreams and My Dreams Said to Crawl, Beach House Depression Cherry, Fleet Foxes Fleet Foxes, Soundgarden Screaming Life (Silver Metallic Vinyl), and Orville Peck Pony. Crissi Bariatti, Senior Merchandise Manager, Music & Video at Barnes & Noble, commented, "As a longtime fan of Sub Pop Records and their artist roster, I am beyond excited to launch this collaboration. Our customers will be eager to pick up their favorite Sub Pop albums while adding to their collection in our vast CD and Vinyl sections. Our goal in the Music department at Barnes & Noble is to offer great music that our shoppers would never find in other national retailers and to give those artists and bands the attention they deserve." Customers who purchase any Sub Pop vinyl album or CD title at a Barnes & Noble retail location receive a free collectable Sub Pop Records/Barnes & Noble branded tote bag, while supplies last. Sub Pop selections are featured on a special endcap display at most Barnes & Noble stores across the U.S throughout this campaign.

08:15 EST Amarin announces to present additional analysis from REDUCE-IT outcomes trial - Amarin announced that investigators will present an additional subgroup analysis from the REDUCE-IT outcomes trial in patients with and without coronary artery disease, CAD, history and mechanistic data on eicosapentaenoic acid, EPA, at the American Heart Association's Scientific Sessions, November 16-18, 2024 in Chicago, IL. "The data to be presented at the AHA Scientific Sessions continues to affirm the clinical utility and value of VASCEPA/VAZKEPA, not only in the overall REDUCE-IT trial population, but also across various subgroups analyzed to date," said Steve Ketchum, PhD, Chief Scientific Officer at Amarin. "Data presented at AHA will showcase new evidence from the REDUCE-IT CAD subanalysis, highlighting the benefits of VASCEPA/VAZKEPA in secondary prevention patients, with and without CAD history."

08:12 EST Ceribell receives authority to operate from Department of Veterans Affairs - CeriBell announced the receipt of an Authority to Operate from the Department of Veterans Affairs. The ATO is a significant milestone in achieving authorization within the framework of federal government cloud computing security requirements and it allows Veterans Administration hospitals to fully deploy Ceribell's point-of-care EEG technology. While Ceribell has been used in certain VA facilities since 2018, this ATO allows Ceribell to leverage VA Wi-Fi networks, enabling remote access to EEG reports and sharing of EEG data between VA locations. Broader use of Ceribell's features will enable VA hospitals to more efficiently manage neurological emergencies by supporting timely interventions and improved patient outcomes. The Ceribell System has the potential to provide continuity of care and reduce costs by helping to avoid the transfer of patients to other facilities. Veterans are at elevated risk of being diagnosed with a seizure disorder, due to conditions such as traumatic brain injury and post-traumatic stress disorder. Ceribell equips frontline healthcare providers with a rapid EEG tool and continuous brain monitoring for critically-ill patients. The Ceribell solution enables VA hospitals to quickly identify and manage non-convulsive seizures, which are difficult to detect and can only be diagnosed with an EEG. The VA's National Tele-EEG program played a pivotal role in helping Ceribell achieve its ATO. The Tele-EEG program, which works to expand neurological care for veterans across the U.S., will manage the implementation of Ceribell across VA hospitals.

08:11 EST Ryde Group expands deal with Singlife on work injury compensation protection - Ryde Group extended it's strategic partnership with Singlife, "a homegrown financial services company." Building on the RydeSafe initiative for riders, Ryde has signed a Memorandum of Understanding MOU with Singlife and will be implementing a comprehensive Work Injury Compensation Act WICA Protection Plan for platform workers from January 1, 2025. This collaboration is a significant step in addressing the unique needs of our driver-partners. It provides driver-partners with financial security and peace of mind, ensuring they are protected against potential risks while on the road. Varun Mittal, Head of Innovation and Ecosystem at Singlife said, "At Singlife, we believe in constantly innovating and helping our customers from all walks of life. Workplace insurance benefits are continuously evolving to cater to the dynamic work environment. Our partnership with Ryde demonstrates our commitment, as a homegrown financial services company, to support our local community. This collaboration marks a key milestone for us in our pursuit to drive financial inclusion for Singapore's gig ecosystem. Through the provision of innovative solutions, including addressing the unique needs of platform workers, we can help boost their financial security and give them a peace of mind."

08:10 EST MicroStrategy provides update on bitcoin, capital markets activity - MicroStrategy announced updates with respect to its bitcoin activity and holdings, capital markets activity, and BTC Yield, a key performance indicator. The company announced that, during the period between October 31 and November 10 the company acquired approximately 27,200 bitcoins for approximately $2.03B in cash, at an average price of approximately $74,463 per bitcoin, inclusive of fees and expenses. The bitcoin purchases were made using proceeds from the issuance and sale of Shares under the sales agreements. As of November 10, the company, together with its subsidiaries, held an aggregate of approximately 279,420 bitcoins, which were acquired at an aggregate purchase price of approximately $11.9B and an average purchase price of approximately $42,692 per bitcoin, inclusive of fees and expenses. Additionally, on October 30, the company entered into a sales agreement with agents, pursuant to which the company may issue and sell shares having an aggregate offering price of up to $21B from time to time through the October sales agents. The company announced that, as of November 10, the company had sold an aggregate of 7,854,647 shares under the sales agreements for aggregate net proceeds to the company of approximately $2.03B. As a result of these sales, the August sales agreement has been substantially depleted and further at-the-market sales of shares will be made under the October sales agreement.

08:08 EST Cognyte in $10M plus expansion agreement with APAC region customer - Cognyte Software announced a significant expansion agreement, valued at over $10M , with a longstanding customer in the Asia-Pacific APAC region. This new agreement expands the capacity of the Cognyte solutions used by local law enforcement agencies LEAs equipping them to better protect border integrity and respond to emerging threats with increased efficiency and precision...."Local law enforcement organizations count on Cognyte to strengthen border security efficiently and effectively," said Efi Nuri, Chief Revenue Officer at Cognyte. "Our solutions have consistently demonstrated significant

08:06 EST Autonomix reports Q2 incurred net losses $2.8M vs $6M last year - "Over the course of the past quarter we have made significant progress in our ongoing human clinical trial and generated a growing body of encouraging data. Looking ahead, we are focused on the successful execution of our trial, with completion on enrollment expected by calendar year end. Based on the data demonstrated to date, we believe our technology has the potential to revolutionize the treatment paradigm for pancreatic cancer pain and bring an effective solution to additional high-value expansion opportunities. We are dedicated to building momentum and driving shareholder value in the near and long term," commented Brad Hauser, Chief Executive Officer of Autonomix.

08:05 EST Annovis sees cash runway for Phase 3 preparatory studies, entering AD study - As of November 8, 2024, Annovis had cash and cash equivalents of $13.6 million. The company has an adequate runway for all Phase 3 preparatory studies and for entering the pivotal Phase 3 AD study in Q1 2025.

08:04 EST Aethlon Medical enrolls first patient in Hemopurifier cancer trial in Australia - Aethlon Medical announced enrollment of the first patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo. The patient was enrolled on October 29 by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia. The first patient completed screening activities confirming their eligibility on November 8 and has now entered a two-month run-in period, receiving anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles and anti-tumor T cell activity will be measured. If imaging after this two-month run-in period reveals no improvement in the patient's tumor, they will be treated with the Hemopurifier, followed by monitoring to identify decreases in EV concentrations and improvements in T cell anti-tumor activity.

08:02 EST Dynavax announces $100M accelerated share repurchase program - Dynavax announced that it has entered into an Accelerated Share Repurchase transaction under an agreement with Goldman Sachs & Co. to repurchase $100M of the company's common stock. Dynavax executed the ASR as part of the $200M share repurchase program authorized by its Board of Directors in November. Upon completion of this ASR, Dynavax will have $100M remaining under the program.

07:39 EST Arch announces recruitment, dosing began in Phase II trial for LSALT peptide - Arch Biopartners announced that patient recruitment and dosing have begun in Canada for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury, CS-AKI. Richard Muruve, CEO of Arch Biopartners, said, "We are happy to see the team at the University of Calgary Hospital recruit and dose the first patient in Canada for our Phase II study targeting CS-AKI. Our five clinical sites in Turkey have made good recruitment progress and have done a great job executing the trial to date. The start of recruitment in Calgary, followed by the activation into the study of the two Toronto hospitals, will significantly boost the momentum of the trial."

07:35 EST Cigna expects to 'actively' repurchase shares in Q4, 2025 - The Cigna Group continues to deliver shareholder value through focused execution against stated operational and financial targets, and via disciplined capital deployment including dividends and share repurchase. Specific to share repurchase, year-to-date the company has repurchased $6B of stock, including $1B thus far in the fourth quarter. The company expects to continue actively repurchasing its shares in the fourth quarter and in 2025. It will use the majority of proceeds from the sale of its Medicare businesses expected to close in the first quarter of 2025 for share repurchase and has $5.3B remaining on its share repurchase authorization.

07:34 EST Altimmune appoints Greg Weaver as CFO - Altimmune announced the appointment of Greg Weaver as CFO, effective immediately. Mr. Weaver will lead the Company's finance and accounting functions, including SEC reporting and investor relations. Most recently, he was CFO of Cognito Therapeutics, a clinical-stage company targeting neurodegenerative diseases.

07:33 EST Zai Lab, Argenx announce China NMPA approval for Vyvgart Hytrulo sBLA - Zai Lab (ZLAB) and Argenx (ARGX) announced that China's National Medical Products Administration, or NMPA, approved the supplemental biologics license application, or sBLA, for Vyvgart Hytrulo 1,000mg for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy, or CIDP. Vyvgart Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.

07:32 EST Cigna says not pursuing a combination with Humana - In light of recent and persistent speculation, The Cigna Group (CI) expects to communicate that the company is not pursuing a combination with Humana (HUM).

07:19 EST Avante partnerss with Scylla for HITL Remote Video Services - Avante introduces Avante Verified, its Human-in-the-Loop Remote Video Services, merging AI video analytics from Scylla Technologies with human intervention. The company said, "This innovative service combines Scylla's unmatched technological capabilities in physical threat detection with the critical oversight of Avante's human operators, who validate and interpret real-time incidents for immediate response. Designed to enhance situational awareness, reduce false alarms, and enable rapid, actionable decision-making, this comprehensive approach represents the future of intelligent security through the following features: AI-Powered Efficiency: Advanced AI algorithms constantly monitor and analyze video feeds, identifying potential risks in real time. Human Expertise: When suspicious activity is detected, human operators review the footage to verify the incident, assess the context, and take appropriate action. Enhanced Accuracy: By reducing false alarms and ensuring accurate threat detection, HITL provides more actionable insights and faster response times. Continuous Learning: The system evolves, as human feedback helps train the AI to become more accurate and contextually aware over time."

07:17 EST Blackstone leads music ABS transaction for Hipgnosis - Hipgnosis (HPGSF), a music rights investment and management company, announced the successful completion of a $1.47B master trust music rights asset-backed securities deal, Lyra 24-2. This transaction represents Hipgnosis Song Assets' second music royalty secularization, after a $222M issuance in 2022. The 2024 deal is backed by royalties from the $2.36B music rights portfolio acquired as part of the take-private of Hipgnosis Songs Fund, a U.K. music royalties investment trust, which comprises 138 catalogues across more than 45,000 songs. Blackstone (BX) has been investing in the music royalties asset class since 2021, and in July 2024, with the SONG transaction, completed one of the largest music take-privates ever, demonstrating continued and strong conviction in the asset class. MUFG Securities was the structuring lead with Barclays, Goldman Sachs, Fifth Third Securities and SMBC Nikko as joint bookrunner. Blackstone Capital Markets served as a co-manager.

07:16 EST Medicenna announces single-agent activity of MDNA11 from dose expansion cohort - Medicenna Therapeutics presented updated clinical results from the ongoing monotherapy dose expansion and combination dose escalation portions of the Phase 1/2 ABILITY-1 study evaluating MDNA11, a long-acting 'beta-enhanced not-alpha' interleukin-2 super-agonist, as monotherapy or in combination with Merck's anti-PD-1 therapy, KEYTRUDA, in patients with advanced solid tumors, at the 39th Annual Meeting of the Society for Immunotherapy of Cancer, held in Houston, Texas, on November 9th, 2024. Key findings from the on-going monotherapy and combination dose escalation portions of the ABILITY-1 study at the time of data cut-off include: Monotherapy Tumor Response in Checkpoint Resistant Patients: MDNA11 continues to demonstrate encouraging deep and durable single-agent anti-tumor activity among patients who progressed on prior ICI therapy: An objective response rate of 30% in the monotherapy dose expansion arm with 3 PRs among 10 patients who had all previously failed ICI therapy and had advanced and/or metastatic melanoma, non-melanoma skin cancer or MSI-H/dMMR tumors irrespective of tumor origin. The ORR is 25% from a total of 20 patients when including 10 phase 2 eligible patients from the MDNA11 monotherapy dose escalation arm who received at least 60 microgram/kg. Objective responses included: 2 PRs among 3 MSI-H patients with both responders having pancreatic ductal adenocarcinoma. One patient with MSI-H PDAC was initially misclassified as MSI-H small bowel cancer with metastases in the pancreas. 1 CR and 2 PRs among 11 patients with cutaneous melanoma. SD in 6 patients including 3 with duration greater than 24 weeks, yielding a clinical benefit rate of 40%. Monotherapy Safety Profile: Key findings from the monotherapy dose escalation and ongoing monotherapy expansion arms of the ABILITY-1 study demonstrate MDNA11's favorable safety profile: As previously reported, DLT or vascular leak syndrome were not observed during monotherapy dose escalation with a majority of treatment-related adverse events being either grade 1 or 2 and resolving within 48 hours; grade 3 TRAEs mainly constituted asymptomatic transient LFT elevations; one isolated grade 4 TRAE was observed with asymptomatic transient LFT elevation in the monotherapy dose expansion arm which resolved within 72 hours without intervention. Repeat administration of MDNA11 at the target doses continues to improve tolerability. Monotherapy Pharmacodynamics: Pharmacodynamic analyses showed potent and durable systemic immune responses following MDNA11 administration with clear evidence of immune activation in the tumor microenvironment: MDNA11 showed significant increases in markers of stemness, central and effector memory and enhanced effector function in circulating CD8+ T and NK cells. Analysis of paired biopsies showed increased tumor infiltration of CD25+ activated CD8+ T cells and NK cells post-MDNA11 treatment. Combination Dose Escalation Safety Profile: No DLTs, grade 4 or 5 TRAEs were observed in combination dose escalation cohorts 1 or 2 during the DLT observation period. The Safety Review Committee approved enrollment of the next higher-dose cohorts as follows: Cohort 3: 120 microgram/kg Q2W MDNA11 and 400 mg Q6W KEYTRUDA; Cohort 4: 120 microgram/kg Q3W MDNA11 and 400 mg Q6W KEYTRUDA. Combination Dose Escalation Pharmacodynamics: Early pharmacodynamic analyses demonstrated robust lymphocyte expansion which was sustained with repeat dosing at both 60 microgram/kg and 90 microgram/kg Q2W MDNA11 in combination with 400 mg Q6W KEYTRUDA. Combination Dose Escalation Tumor Response: Encouraging preliminary signs of anti-tumor activity were observed with MDNA11 in combination with KEYTRUDA in dose escalation cohorts 1 and 2. Among 5 heavily pre-treated efficacy-evaluable patients, tumor control was observed in 4 patients including a PR in a microsatellite-stable colon cancer patient.

07:13 EST TriSalus Life Sciences teams with Geo-Med to expand TriNav availability to VA - TriSalus Life Sciences has announced a strategic partnership with Geo-Med to expand availability of the TriNav Infusion System to U.S. Department of Veterans Affairs medical centers nationwide. Fittingly, on the day honoring our veterans, we announce this pivotal collaboration designed to expand access for U.S. veterans to our proprietary PressuMike Locke, Chief Executive Officer of Geo-Med, added, "We are proud to collaborate with TriSalus to bring this innovative delivery technology to veterans. Liver cancer is a particularly aggressive disease, and by expanding access to TriNav, we're providing veterans with the latest advancements in treatment." re-Enabled Drug Delivery approach. PEDD is enabled by TriNav, a promising technology with the potential to improve liver cancer outcomes," said Mary Szela, Chief Executive Officer and President of TriSalus. "We are thrilled to partner with Geo-Med to increase access to TriNav for veterans battling liver cancer. This collaboration is closely aligned with our mission to enhance patient outcomes, particularly for those who have served our country." ...

07:12 EST Chimerix announces updates Phase 2 data at 2024 SNO meeting - Chimerix announced upcoming presentations at the 2024 Society for Neuro-Oncology, SNO, Annual Meeting, which will be held in Houston, TX from November 21 - 24, 2024. "We are excited to provide an updated assessment of objective response to dordaviprone previously reported in the blinded independent central review cohort1 in recurrent H3 K27M-mutant diffuse midline glioma using Response Assessment in Neuro-Oncology 2.02, the most recently established criteria for this disease. This analysis demonstrates an overall response rate of 28.0%, a median time to response of 4.6 months plus a median duration of response of 10.4 months," said Allen Melemed, MD, Chief Medical Officer at Chimerix. We expect to include the updated RANO 2.0 results in our planned upcoming New Drug Application to Australian regulators."

07:10 EST Ryvyl signs MOU with investor to retire 8% senior convertible note - RYVYL has signed a non-binding Memorandum of Understanding with the investor setting forth the terms agreed to by the Company and the Investor for the full repayment and termination of an 8% Senior Convertible Note and the redemption of all shares of the Company's Series B Convertible Preferred Stock held by the Investor. As of October 31, 2024, the outstanding Note principal was $19.0 million, and the liquidation value of the Preferred Stock was $53.5 million. Under the terms of the MOU, the Company has agreed to pay total consideration of $16.5 million in full repayment of the Note and the redemption of all of the shares of Preferred Stock, as follows: $12.8 million will be paid in a first tranche payment on or before November 22, 2024, for the redemption of all of the shares of Preferred Stock held by the Investor, and payment of a portion of the outstanding balance of the Note so that the remaining outstanding principal balance will be $3.7 million. $3.7 million will be paid in payment of the principal balance of the Note, which will remain outstanding under the existing Note with the maturity date of the Note being advanced to January 31, 2025. The Company is required to execute definitive agreements with the Investor and pay the first tranche payment of $12.8 million on or before November 22, 2024, or the MOU will be terminated and the transactions contemplated under the MOU will not be completed. RYVYL expects to pay the first tranche payment of $12.8 million from proceeds raised in equity, debt and/or convertible debt financings from one or more new investors. The Investor's consent is required for RYVYL to enter into any of such financing transactions, unless RYVYL deposits at least $12.8 million, in escrow, for the payment of the first tranche payment, upon execution of the Definitive Agreements, in which case the Investor's consent is not required. In the event that RYVYL is unable to raise funds sufficient to pay the first tranche payment of $12.8 million by November 22, 2024, the transactions contemplated under the MOU will not be completed. The Company will use its reasonable best efforts to raise the financing required, but THERE IS NO ASSURANCE that it will be able to do so by November 22, 2024. Even if the Company does raise sufficient funds, since the MOU is not binding, there is no assurance that the Company will be able to enter into the Definitive Agreements with the Investor.

07:08 EST First Watch Restaurant agreed to acquire 16 franchise restaurants for $49M - First Watch Restaurant Group announced it has agreed to acquire 15 of its franchise-owned restaurants, one restaurant currently under construction and corresponding development rights in North Carolina and South Carolina for an aggregate purchase price of $49 million on a cash-free, debt-free basis, subject to certain customary adjustments. The restaurant currently under construction is expected to open prior to the closing of the transaction.

07:05 EST ARS Pharmaceuticals announces agreement with ALK to commercialize neffy - ARS Pharmaceuticals (SPRY) announced a licensing agreement with ALK-Abello A/S (AKBLF), that provides ALK exclusive rights to commercialize neffy, the first and only needle-free emergency treatment for Type I allergic reactions including anaphylaxis, in Europe, Canada and other geographies outside of the U.S. ARS Pharma retains all rights to neffy in the U.S., and there are no changes to its existing partnerships in Japan, China, Australia and New Zealand.

07:04 EST Unicycive Therapeutics announces U.S. FDA acceptane for NDA for OLC - Unicycive Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted the New Drug Application, NDA, for Oxylanthanum Carbonate, OLC, and has set a Prescription Drug User Fee Act, PDUFA, target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease, CKD, on dialysis.

06:52 EST Aramark jumps 7% to $41.93 after Q4 results, FY25 guidance

06:46 EST Inspire Medical authorizes $75M accelerated share repurchase program - Inspire Medical entered into an accelerated share repurchase transaction under an agreement with Goldman Sachs to repurchase an aggregate of $75.0M of shares of the company's common stock, par value 0.1c per share. The ASR transaction is being completed pursuant to a previously announced $150.0M share repurchase program authorized by the company's Board of Directors. The ASR transaction is scheduled to terminate in Q1 2025. The share repurchase program will expire on August 5, 2026, subject to the earlier termination or extension by the Board, in its sole discretion and without prior notice, or until such time that the funds designated for the stock repurchase program are depleted.

06:36 EST Aramark raises quarterly dividend 11% to 10.5c per share - Aramark's Board of Directors approved an 11% increase to the quarterly dividend. The dividend of 10.5c per share of common stock will be payable on December 12 to stockholders of record at the close of business on December 2.

06:32 EST Hyperscale Data announces date, ratio of reverse stock split - Hyperscale Data announces date of effectiveness and the ratio of a forthcoming reverse stock split of the Class A Common Stock. On June 28, the company announced, on a Current Report on Form 8-K, the voting results from the annual meeting of stockholders held that day. At the Meeting, stockholders voted upon and approved Proposal 5, an amendment to the company's Certificate of Incorporation to effect a Reverse Split with a ratio of not less than one-for-two and not more than one-for-thirty-five at any time prior to June 27, 2025, with the exact ratio to be set at a whole number within this range as determined by the company's board of directors in its sole discretion. On October 24, the Board authorized a special committee of the Board to determine the ratio of the Reverse Split. On November 8, the Committee approved a one-for-thirty-five Reverse Split of the Common Stock that will be effective in the State of Delaware on Friday, November 22. The company anticipates that beginning with the opening of trading on Monday, November 25, the company's Common Stock will trade on the NYSE American on a split-adjusted basis under a new CUSIP number, 09175M 804.

06:22 EST BrainStorm enters MOU with Pluri to support NurOwn trial - BrainStorm (BCLI) announced that it has entered into a memorandum of understanding, or MOU, with Pluri (PLUR) through its wholly owned subsidiary to manufacture NurOwn for use in BrainStorm's planned Phase 3b trial in amyotrophic lateral sclerosis, or ALS. This MOU enables BrainStorm to begin transfer of its manufacturing technology and start producing NurOwn at Pluri's manufacturing facility upon finalizing the binding definitive agreement. Under the terms of the proposed agreement, Pluri will provide GMP-compliant manufacturing of NurOwn at its facilities in Israel. This collaboration aims to fulfill essential supply requirements of NurOwn as BrainStorm advances its Phase 3b clinical trial. Additionally, the two companies are exploring options for manufacturing to support potential future commercial distribution, pending approval of NurOwn. The Phase 3b trial has been designed to enroll up to approximately 200 participants with ALS. It will be conducted in two parts: In Part A, participants will receive 3 doses of NurOwn or placebo for 24 weeks. This will be followed by an open label period, during which patients from both arms will receive 3 doses NurOwn for another 24 weeks. The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 for NurOwn vs. placebo. Successful completion of Part A of the double-blind Phase 3b study will position BrainStorm to submit a Biologics License Application, or BLA, for regulatory approval, potentially accelerating the path to market.

06:13 EST Solidion enters MOU with Bluestar Materials to leverage its patent portfolio - Solidion announced a strategic memorandum of understanding, or MOU, with Bluestar Materials Company of Taiwan. This agreement will leverage Solidion's patent portfolio and accelerate the commercialization of its anode technology, including its recently disclosed technology that allow lithium batteries to be charged in five minutes. The agreement will enable Solidion to explore and establish synergies in U.S. based manufacturing, commercialization strategies, and market opportunities related to Silicon, or Si, and Silicon Oxide advanced battery solutions.

06:03 EST GE HealthCare and RadNet collaborate in imaging systems innovation - GE HealthCare (GEHC) and DeepHealth, a wholly-owned subsidiary of RadNet (RDNT), announced a strategic collaboration to further the innovation, commercialization, and adoption of AI in imaging. Together, the two companies aim to develop SmartTechnology solutions that harness the power of AI to address key challenges across the imaging value chain, including helping increase the efficiency of imaging interpretation and reporting, enabling collaboration across care teams, improving the clinical interpretation of images, and enhancing operational efficiency and productivity. The two companies will first work to bring together DeepHealth's AI-based SmartMammo workflow and clinical solution and GE HealthCare's patient-centric Senographe Pristina mammography system to add AI-powered clinical imaging support to breast cancer screening. Through this collaboration, the two companies also seek to include Smart Alerts, a DeepHealth workflow solution to be integrated with Senographe Pristina that will utilize rapid AI processing with the goal of alerting imaging sites to cases with potentially suspicious lesions in minutes. The two companies' agreement will enable GE Healthcare to distribute SmartMammo and other DeepHealth solutions to imaging providers in the United States as part of GE HealthCare's comprehensive portfolio of imaging technologies. In addition to collaborating on SmartMammo, GE HealthCare and RadNet's DeepHealth intend to explore areas of further collaboration for SmartTechnology solutions in other modalities and clinical domains, to expand the access to and impact of AI-based workflows.

05:32 EST Tradeweb Markets, Tokyo Stock Exchange team to expand liquidity in Japanese ETFs - Tradeweb Markets and Tokyo Stock Exchange, or TSE announced their collaboration to offer institutional investors enhanced access to liquidity in Japanese exchange-traded funds, or ETFs. The launch of a new direct link between Tradeweb and TSE's request-for-quote, or RFQ, platform, Conneqtor, allows Tradeweb buy-side clients to include Conneqtor liquidity providers when launching a trade enquiry on the Tradeweb Japan-listed ETF marketplace. Global X Japan executed the first transaction using this new connectivity.

05:17 EST Nokia, Fibertime expand broadband access across South Africa - Nokia announced that Fibertime will deploy its fiber solution to rapidly expand broadband access to underserved regions of South Africa. Fibertime will quickly connect the next 1.5M customers leveraging Nokia's Lightspan FX Optical Line Terminals and Wi-Fi 6 enabled Optical Network Terminals. Nokia's technologies are key to enabling Fibertime's flagship product: R5 a day for uncapped, unthrottled internet. The fiber deployment will initially cover Cape Town, Johannesburg, Gqeberha, Mangaung and Stellenbosch, with plans to rapidly expand into additional countries and communities. As part of the agreement, Fibertime will deploy 500,000 Nokia Wi-Fi 6 enabled ONTs over the next 36-months, prioritizing homes in underserved areas.

05:11 EST Amcor AmFiber Performance Paper receives European patent - Amcor has been granted a European patent for paper packaging with thin film barrier, affirming the attributes of its AmFiber portfolio. AmFiber Performance Paper is a high-barrier, paper-based solution that delivers recyclability and high-speed customer line performance for food- and healthcare-grade packaging.