Capricor Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its deramiocel cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The agency cited insufficient evidence of efficacy and outstanding manufacturing issues, signaling a departure from previous regulatory flexibility for DMD therapies. Capricor expressed surprise and will await Phase III trial data to support future filings. These regulatory developments have led to a significant stock price drop and uncertainty about the therapy’s approval timeline.