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September 2025 Letter to Shareholders
Globenewswire· 2025-09-30 12:30
VANCOUVER, Washington, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As this pivotal year continues to take shape for CytoDyn Inc. (“CytoDyn” or the “Company”), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evi ...
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access
Globenewswire· 2025-09-30 12:30
Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Compan ...
Energy Fuels, Firefly Aerospace And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - bioAffinity Technologies (NASDAQ:BIAF), First Majestic Silver (NYSE:AG)
Benzinga· 2025-09-30 12:04
U.S. stock futures were lower this morning, with the Dow futures falling more than 100 points on Tuesday.Shares of Energy Fuels Inc (NYSE:UUUU) fell sharply in pre-market trading after the company announced a proposed $550 million private offering of convertible senior notes due 2031.Energy Fuels shares dipped 6.4% to $15.47 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Epsium Enterprise Limited (NASDAQ:EPSM) fell 24.3% to $18.60 in pre-market trading after dipping 30% ...
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
Newsfile· 2025-09-30 11:40
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory UpdateSeptember 30, 2025 7:40 AM EDT | Source: OS TherapiesCompany updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRAIn principle, UK MHRA accepts use of historical control arm to support conditional MAAUK MHRA conditional MAA and US FDA Biologics Licensing ...
New Binance Coin and Aethir Treasuries Raise Over $400M To Launch
Yahoo Finance· 2025-09-30 11:32
The DAT era is here. | Credit: Credit: Raymond Boyd/Getty Images.. Key Takeaways Digital Asset Treasuries are publicly traded firms dedicated to accumulating crypto. Aethir is a DePIN project offering GPU-as-a-service solutions for AI, gaming, and cloud. Binance Coin treasuries currently comprise over $500 million worth of BNB. Two new Digital Asset Treasuries (DATs) from two separate biotech firms are set to launch after raising a combined $402 million in private placements to acquire huge sums o ...
Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI™ (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung Cancer
Businesswire· 2025-09-30 11:30
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZIâ"¢ (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC). "While surgi. ...
Precision BioSciences Announces Late-Breaking Poster Presentation at the 30th Annual International Congress of the World Muscle Society
Businesswire· 2025-09-30 11:01
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society (WMS) being held October 7-12, 2025, in Vienna, Austria. "We look forward to sharing the latest preclinical data for PBGENE-DMD at the upcoming. ...
BioMarin: Valuation, Growth, And The Pipeline May Outweigh TransCon Competition And Regulatory Risks
Seeking Alpha· 2025-09-30 11:01
Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in BMRN over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...
CollPlant Biotechnologies Announces Positive Results from non-clinical Studies of its Photocurable Regenerative Dermal and Soft Tissue Filler
Prnewswire· 2025-09-30 11:00
Accessibility StatementSkip Navigation CollPlant is now moving towards clinical trials and scaling and optimizing its manufacturing to ensure readiness for the upcoming clinical trials REHOVOT, Israel, Sept. 30, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing disruptive technologies and products based on its proprietary non-animal recombinant human collagen (rhCollagen), today announced positive results from its non-clinical program eva ...
NLS Pharmaceutics Shareholders Approve Merger with Kadimastem and Related Proposals at Extraordinary General Meeting
Prnewswire· 2025-09-30 11:00
Ronen Twito, Kadimastem's Executive Chairman and CEO and Alexander C. Zwyer NLS's CEO & Executive Board Member stated: ""We are grateful to our shareholders for their strong support of the merger. Today's outcome marks a pivotal step in creating NewCelX, a transatlantic biopharma leader†The merger will create: Nasdaq-listed company: Under the symbol "NCEL": Governance and capital structure approvals completed Diversified pipeline: Unites Kadimastem's advanced cell therapy programs (including a Phase 2a AL ...