Capricor Therapeutics said the FDA extended its review of deramiocel (the company’s Duchenne muscular dystrophy cell therapy candidate) after a negative advisory committee vote, pushing further decision-making on a more refined indication. In parallel, the agency also delayed the PDUFA date again to review additional data tied to the narrowed use case. Capricor characterized the move as a reprieve as regulators requested more supporting information. For DMD developers, the decision highlights continued regulatory sensitivity around dataset sufficiency for benefit-risk, even after prior advisory committee outcomes.