Outlook Therapeutics, Inc. OTLK stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.Outlook Therapeutics traded lower, with a session volume of 26.41 million compared to the average volume of 1.51 million as per data from Benzinga Pro.FDA UpdateThe agency issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degenera ...

Key Takeaways Amvuttra drove $801.9 million in H1 2025 sales, up 89% year over year.U.S. and EU nods expanded Amvuttra's use to ATTR-CM, boosting uptake.Competition from Pfizer's Vyndaqel and BridgeBio's Attruby poses challenges.Alnylam Pharmaceuticals (ALNY) is a commercial-stage company that currently markets four drugs. The company first received regulatory approval in 2018 for Onpattro to treat adult patients with hereditary transthyretin-mediated (hATTR) amyloidosis. Subsequently, ALNY received approva ...

With a background as an RN and an MBA, Stephen analyzes healthcare and tech stocks through the lens of investment process design. His work is guided by his proprietary "Dizzy Framework," a system developed to counter common behavioral errors like chasing market noise or rigidly sticking to priors. By focusing on the quality and timing of information, the framework enforces a patient and disciplined approach, translating complex science and market dynamics into truly actionable theses. His influences include ...

Key Takeaways Inovio stock rises 20.6% after the FDA allows a rolling BLA for INO-3107 in RRP.The company aims to seek priority review for INO-3107, cutting FDA review time to six months.INO-3107 has breakthrough therapy and orphan drug designations for RRP.Shares of Inovio Pharmaceuticals (INO) jumped 20.6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for INO-3107 in adult patients with recurrent respiratory papi ...

EXTON, PA, Aug. 28, 2025 (GLOBE NEWSWIRE) -- The recent approval of Novo Nordisk’s Wegovy (semaglutide 2.4mg) as the second treatment for metabolic dysfunction-associated steatohepatitis (MASH) represents a critical step forward in a condition with a vast patient population and significant unmet need. Highly anticipated by the field, this milestone is expected to transform the future of MASH care.  Findings from a Spherix Global Insights pulse study among gastroenterologists and hepatologists (n=77) conduct ...

TEL AVIV, Israel, Aug. 28, 2025 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (the "Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, announced today that AutoMax Motors Ltd. ("AutoMax"), a leading parallel vehicle importer in Israel, convened today its special general meetings, at which, among others, AutoMax’s shareholders voted on and approved the proposed merger with SciSparc. In additi ...

REDWOOD CITY, Calif., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for the efficient and scalable manufacturing of complex therapeutics, today announced the Company will attend the Cantor Global Healthcare Conference, being held September 3-5, 2025, in New York, New York. Management will participate in a fireside chat on Thursday, September 4, 2025, at 3:55 pm ET. A live webcast of the event will be available in the Investor Relations section of t ...

HOUSTON, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 16,216,216 shares of common stock of the Company originally issued in June 2025 at an exe ...

Generic Saxenda® is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market.This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy.Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and pediatric patients (12-17 years) with a weight greater than 60 kg and obesit ...

CHAPEL HILL, N.C., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced that the Company will participate in a fireside chat at the Cantor Global Healthcare Conference 2025, which is taking place from September 3-5, 2025, in New York, NY. Details of presentation: Format: Fireside chat Participants: Chris Giordano ...