Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA
Capricor Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, a novel cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026. The extension follows submission of new 24-month open-label extensi…