Business Wire

31. Nosis Biosciences Announces Research Collaboration And Option Agreement With Daiichi Sankyo To Develop Cell-Targeted RNA Medicines 3/11/2025

    Nosis Biosciences, an AI-driven biotechnology company specializing in RNA therapeutics for challenging cell types, today announced it entered into a Research Collaboration and Option Agreement with Daiichi Sankyo.

32. The US FDA Grants Both Orphan Drug And Rare Pediatric Disease Designations To NEU-001 Of Neurenati For The Treatment Of Hirschsprung Disease 3/4/2025

     Neurenati Therapeutics Inc., a biotech company focused on rare pediatric diseases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to NEU-001, a novel combination therapy utilizing a neurotrophic growth factor, for the treatment of Hirschsprung disease (HD).

33. Laekna Announces IND Approval Of LAE120 (A Novel USP1 Inhibitor) For Treatment Of Advanced Solid Tumors By FDA 3/3/2025

    Laekna (2105.HK) announced that the U.S. Food and Drug Administration (FDA) has approved the IND for LAE120, an internally discovered USP1 inhibitor, for the treatment of advanced solid tumors.

34. Enveda Gains Backing From Sanofi To Advance AI-Driven Drug Discovery To Clinical Trials Bringing Total Series C Financing To $150M 2/26/2025

    Enveda, a leading biotechnology company harnessing life’s chemistry to discover better medicines, today announced an investment from Sanofi, a leading healthcare company.

35. FDA Grants Orphan Drug Designation To Revolutionary Cystic Fibrosis Therapy 2/25/2025

    Porosome Therapeutics, Inc. (Porosome Therapeutics) today announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).

36. Glaukos Announces FDA Acceptance Of NDA Submission For Epioxa 2/24/2025

    Glaukos Corporation an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review.

37. Summit Therapeutics Announces Clinical Trial Collaboration With Pfizer To Evaluate Ivonescimab In Combination With Pfizer Antibody Drug Conjugates (ADCs) 2/24/2025

    Summit Therapeutics Inc. today announced a clinical trial collaboration with Pfizer Inc. to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of Pfizer’s antibody drug conjugates (ADCs) across multiple solid tumor settings.

38. Variational AI Announces Oversubscribed $5.5M Financing To Launch Foundation Model For Small Molecule Drug Discovery 2/20/2025

    Variational AI, the company behind Enki,an advanced foundation model for small molecule drug discovery, today announced the completion of its oversubscribed $US5.5M Seed extension round.

39. Lantern Pharma Announces PCT Patent Application Publication For Innovative, High Performing, Machine Learning Model For Predicting Blood Brain Barrier Permeability Of Drug-Candidates 2/19/2025

    Lantern Pharma Inc. an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, today announced the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability.

40. U.S. FDA Accepts Gilead's New Drug Applications For Twice-Yearly Lenacapavir For HIV Prevention Under Priority Review 2/18/2025

    Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).