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, ...

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 ...
Nasdaq

Ocugen Announces FDA Alignment to Advance Phase 2/3 Trial for OCU410ST in Stargardt Disease

Ocugen announces FDA alignment for Phase 2/3 trial of gene therapy OCU410ST for Stargardt disease, showing promising initial results. Ocugen, Inc. announced it has received FDA approval to proceed ...
Seeking Alpha

Acurx signals progress in Phase 3 ibezapolstat program with $12M credit line following regulatory alignment

Luci indicated the company is focused on securing additional funding opportunities to support the Phase 3 ibezapolstat clinical trial program and expects further updates on funding initiatives in ...
Seeking Alpha

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

Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) -- INmune ...