Nasdaq

Chemomab Therapeutics Announces FDA Alignment on Phase 3 Trial Design for Nebokitug as Potential First Treatment for Primary Sclerosing Cholangitis

Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...

Artiva Announces Positive Initial Clinical Data with AlloNK® Across Multiple Autoimmune Diseases and FDA Alignment to Initiate Phase 3 Registrational Trial in Rheumatoid ...

Initial clinical data demonstrated 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up in ...
pharmaphorum

The expanding role of early-phase trials in modern drug development

The evolving role of early-phase clinical trials reflects a broader truth: decisions made early carry increasing weight in ...
Business Insider

NervGen Pharma Announces Successful End-of-Phase 2 Meeting and FDA Alignment on RESTORE, a Phase 3 Registrational Study of NVG-291 for Chronic Tetraplegia

Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in ...
Yahoo Finance

INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease

Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today ...
Nasdaq

IMUNON, Inc. Advances IMNN-001 for Ovarian Cancer with FDA Alignment on CMC Strategy Ahead of Phase 3 Trial

IMUNON announced FDA alignment on CMC strategy for IMNN-001, preparing for a Phase 3 trial in advanced ovarian cancer. IMUNON, Inc. announced a successful Type C Chemistry, Manufacturing, and Controls ...