CR-001 IND cleared by U.S. FDA; Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data anticipated in first quarter of 2027 Crescent partner Kelun-Biotech receives IND approval for CR-003 (SKB105) by NMPA of China Four clinical trials across portfolio expected to initiate in 2026 Jan. 05, 2026 -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clin

Jan. 05, 2026 -- MapLight Therapeutics, Inc. (“MapLight”) (Nasdaq: MPLT) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an investigational novel M1/M4 muscarinic agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The Fast Track process is intended to facilitate the development and expedite the review of investigational therapies for serious conditions with unmet medi

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 -- 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

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 -- LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company developing first-in-class, orally delivered immune-tolerance-restoring therapies, announced today that the first patient has been dosed in its Phase Ib clinical study of LPX-TI641 in adults with atopic dermatitis (AD). The Phase Ib study evaluates LPX-TI641 in a chronic inflammatory disease characterized by Th2-mediated immune dysregulation, extending the company’s prior clinical work in autoimmune