Dec. 31, 2025 -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317, an in

Palisade Bio Announces Granting of Japanese Patent Covering Composition of Matter for Lead Product Candidate, PALI-2108 PALI-2108 is the first and only PDE4 inhibitor in development targeting the terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs Ongoing development of PALI-2108 across FSCD and UC, with Phase 2 IND submission planned for H1 2026 Dec. 30, 2025 -- Palisade Bio, Inc. (Nasdaq: PALI)

Dec. 30, 2025 -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a diversified developmental stage biopharmaceutical and cryptocurrency treasury company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a non-binding Letter of Intent (“LOI”) with Allucent (US) LLC (“Allucent”), a global clinical research organization (CRO), to provide clinical research services for two plan

Dec. 30, 2025 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation for bezuclastinib in patients wit

While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in c

— NDA supported by positive Phase II registration study data in Chinese patients; follows Breakthrough Therapy Designation granted in 2023 — — Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer — Dec. 30, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophage

Dec. 30, 2025 -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), today announced the closing of its inaugural syndicated credit facility. The new aggregate $980 million credit facility will mature in 2030 and consists of a $580 million initial Term Loan, $300 million Delayed Draw Term Loan, and $100 million revolving credit facility (collectively the “Credit Facility”). The initial Term Loan was used to repay approximately $581 million of principal representing the entire remaining balance of th

LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function Top-line results in healthy volunteers anticipated in 2H’26 Dianthus to provide update on indication prioritization in 1H’26 LBL-047 (DNTH212) has the potential to be a first-line biologic in multiple autoimmune disorders with patient-friendly S.C. self-administration and Q4W or less fre

Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma Approval based on global phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function compared to placebo (by 4.68% to 5.32%) Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study, and inhibits IL-4 and IL-13, two key and central driver

Dec. 23, 2025 -- Vaccinex, Inc. (VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) by inhibiting semaphorin 4D (SEMA4D) induced pathology in brain, today announced that it has entered into a $60 million revenue sharing agreement with Pepinemab Development Venture, LP (PDV) to continue advancing development of its pepinemab anti-SEMA4D antibody in an enlarged phase 2b clinical trial for treatment of AD. PDV LP is an investment