FDA grants Fast Track designation to DPTX3186, Dewpoint’s first in class condensate modulator for gastric cancer Designation provides increased FDA engagement, rolling review eligibility, and potential for accelerated development Follows recent IND opening, and Orphan Drug Designation, as Dewpoint prepares to initiate a Phase 1a/2a clinical trial this year Nov. 17, 2025 -- Dewpoint Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes Recommendation based on the TN-10 study, demonstrating Teizeild’s ability to delay the onset of stage 3 type 1 diabetes (T1D), compared to placebo, in adults and children with stage 2 T1D If approved, Teizeild would become the first disease-modifying T1D therapy in the EU November 14, 2025. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a p

Windtree has a total of 59 issued or allowed patents and 17 pending patents for Istaroxime and its SERCA2a activators Windtree received recent notification of allowed Istaroxime patents for acute heart failure in Canada and Mexico The pure SERCA2a activators patent for acute heart failure was granted in Isreal Nov. 14, 2025 -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (OTCID: WINT), a diversified company with several divisions and focused on becoming a revenue generating compan

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