Current Headlines

1. Basilea And Phare Bio Enter Partnership Combining Anti-Infectives Industry Expertise With Unique AI Capabilities For The Development Of A Novel Antibiotic 12/11/2025

   Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today a partnership with Phare Bio Inc., Boston (USA), a biotech social venture that uses Artificial Intelligence (AI) to accelerate antibiotic discovery and development.

2. Chemify Receives An Additional Grant To Accelerate Digital Chemistry Small-Molecule Discovery For Tuberculosis 12/10/2025

   Chemify, the deep-tech pioneer fusing chemistry, robotics, computation, and Chemputation—Chemify’s purpose-built AI to digitize molecule creation—has received additional grant funding of $1.6M from the Gates Foundation to continue the discovery of small molecules for tuberculosis (TB).

3. Ascletis Announces China National Medical Products Administration Acceptance Of New Drug Application For Denifanstat (ASC40), A First-In-Class FASN Inhibitor For Acne Treatment 12/10/2025

   Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).

4. Sagimet's License Partner Ascletis Announced Acceptance Of New Drug Application For Denifanstat For The Treatment Of Moderate To Severe Acne By China's National Medical Products Administration 12/10/2025

   Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne.

5. Teva Pharmaceuticals Submits New Drug Application To FDA For Olanzapine Extended-Release Injectable Suspension (TEV-'749) For The Once-Monthly Treatment Of Schizophrenia In Adults 12/9/2025

   Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.

6. Bora Pharmaceuticals And Corealis Pharma Forge Strategic Alliance To Deliver Seamless, End-To-End Oral Solid Dose Development 12/9/2025

   Bora Pharmaceuticals Co., Ltd. ("Bora", TWSE: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing.

7. Ocular Therapeutix™ Announces Plans To Accelerate NDA Submission Timeline For AXPAXLI™ In Wet AMD 12/8/2025

   Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026.

8. Ouro Medicines Receives U.S. FDA Orphan Drug Designation For Gamgertamig (OM336) For Immune Thrombocytopenia 12/8/2025

   Ouro Medicines, a biotechnology company developing immune reset therapeutics for people living with chronic, immune-mediated diseases, today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody candidate, has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for development in the treatment of immune thrombocytopenia (ITP).

9. Agora Open Science Trust Announces Nomination Of M4K2009 As Lead Development Candidate For Pediatric Brain Cancer Therapy 12/8/2025

   Agora Open Science Trust today announced the nomination of M4K2009 as the lead development candidate for its M4K Pharma program, which applies open science to drive the development of an affordable treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare and devastating pediatric brain cancer.

10. AI-For-Science Startup ChemLex Raises USD 45M, Launching Self-Driving Lab For Drug Discovery In Singapore 12/7/2025

    ChemLex, a next-generation AI-for-science company, today announced the establishment of its global headquarters and self-driving laboratory in Singapore, alongside the close of a USD 45 million funding round led by Granite Asia.