FDA Resumes Review of Deramiocel for Duchenne Muscular Dystrophy

The U.S. FDA has lifted a Complete Response Letter (CRL) and resumed its review of the Biologics License Application (BLA) for Deramiocel, Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy (DMD). The Prescription Drug User Fee Act (PDUFA) target action date is set for August 22, 2026. Deramiocel, based on donor cardiosphere-derived cells, is being evaluated for the treatment of skeletal and cardiac manifestations of the muscle-wasting disease.