Capricor Therapeutics Announces FDA Extension of PDUFA Target Action Date for Deramiocel BLA to November 22, 2026

Capricor Therapeutics has announced that the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel. The investigational cell therapy for Duchenne muscular dystrophy (DMD) now has a new target action date of November 22, 2026, extended from August 22, 2026. This extension follows Capricor's submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication.