Capricor Therapeutics received a complete response letter (CRL) from the FDA rejecting its biologics license application for deramiocel, an off-the-shelf cell therapy targeting cardiomyopathy in Duchenne muscular dystrophy patients. The agency cited insufficient evidence of effectiveness, unresolved Chemistry, Manufacturing, and Controls (CMC) issues, and the need for more clinical data from ongoing Phase III studies. The unexpected decision caused Capricor’s stock to drop significantly, signaling challenges for the company’s regulatory path forward.