Nov. 13, 2025 -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study. A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements. START will assess the safety and activity of zervimesi

Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025 Nov. 13, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab

Nov. 12, 2025 -- Chiesi Group today announced it has entered into an exclusive license agreement with Aliada Therapeutics, a wholly owned subsidiary of AbbVie, to advance blood-brain barrier (BBB)-crossing platform technology in lysosomal storage disorders (LSD) to address challenging disease areas with high unmet need. “This agreement underscores our continued commitment to creating potential solutions that target the significant unmet needs in managing cognitive and neurological symptoms acr

Preclinical research to be conducted at the University of North Carolina at Chapel Hill (UNC) Annamycin will be used in conjunction with novel agents and modalities Preclinical studies indicate Annamycin targets key factors in pancreatic cancer Nov. 12, 2025 -- 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 cancers and viral infections, today announced it has entered i

RPT1G is the first well-tolerated NAMPT inhibitor, demonstrating safety in healthy volunteers at single and multiple ascending dose levels. Target engagement data indicate that RPT1G inhibits NAMPT in humans at doses predicted to be therapeutically relevant for hematologic malignancies. FDA has cleared Remedy Plan's IND application for RPT1G in R/R AML and HR-MDS. Remedy Plan granted orphan drug designation for RPT1G in AML. Nov. 12, 2025 -- RPT1G, a revolutionary new NAMPT inhibitor develope

Nov. 12, 2025 -- SEED Therapeutics, Inc. (“SEED”), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, today announced that China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for ST-01156. This clearance enables the inclusion of Chinese clinical sites in SEED’s planned global expansion study, which will follow the completion of the ongoing first-in-human

Data expected H2 2026 Rare liver disease with no approved treatment, typically concurrent with Inflammatory Bowel Disease (IBD) Second YAQ001 clinical study following successful cirrhosis trial Nov. 12, 2025 -- Yaqrit, a late clinical-stage company developing life-saving treatments for advanced liver diseases, announced today that the first patient has been treated in a proof-of-concept study of its advanced, oral microbiome treatment, YAQ001, also known as Carbalive, in primary sclerosing

– Exploratory Phase 2 analysis shows Verrica’s novel oncolytic peptide, VP-315, reprograms the tumor microenvironment, increasing cytotoxic T-cell infiltration and reducing immunosuppressive T-regulatory cells – – Findings provide mechanistic immunologic support for clinical efficacy previously reported, including 97% calculated objective response rate and 51% complete histologic clearance rate – – Coupled with VP-315’s previously reported safety profile, these results highlight VP-315’s potenti

Nov. 11, 2025 -- March Biosciences (March Bio), a clinical stage biotechnology company developing cell therapies for hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-105, the Company’s first-in-class autologous CD5-targeted CAR-T cell therapy, in development for relapsed/refractory CD5-positive T-cell lymphoma. The RMAT designation was granted based on data from March Bio’s ongoin

Nov. 10, 2025 -- Transition Bio, a drug discovery company focused on unlocking traditionally “undruggable” targets by leveraging biomolecular condensates, and Voyager Therapeutics (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, have entered into a drug discovery collaboration and license option agreement. The companies will collaborate to discover and develop novel, selective small molecules for people suffering from amyotrophic lateral s