Emerging gene therapy administered through a one-time subretinal injection marks a major milestone for the inherited retinal disease community Initial data expected in Q1 2026 Nov. 13, 2025 -- Opus Genetics, (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the first participant has been dosed in the Company’s OPGx

AI-discovered candidate CHM-029 demonstrates robust, dose-dependent tumor regression in pre-clinical AML models and retains potency against all known resistance mutations First-in-human trials expected to begin in Q2 2026 13 November 2025 -- CHARM Therapeutics (“CHARM”, “The Company”), today announced the advancement of CHM-029, a next-generation pan-menin inhibitor designed to overcome resistance mutations, as a development candidate for the treatment of acute myeloid leukemia (AML). It is exp

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

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

– 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

Phase 2a data support oral C5aR inhibitor INF904 as a potentially transformational and best-in-class immunomodulatory agent, indicating strong potential for efficacy and no safety signals of concern In HS, over 4 weeks of therapy, InflaRx observed rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, with substantial reductions in patient reported pain scores, ov

225Ac-SSO110 has received U.S. FDA Orphan Drug Designation Initial safety data from SANTANA-225 in ES-SCLC and MCC expected in 2026 Potential to address a broad range of neuroendocrine cancers Nov. 11, 2025 -- Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, today announced that the first patient has been dosed in the SANTANA-225 Phase 1/2 study of 225Ac-SSO110 for the treatment of extensive stage small cell lung cancer (ES