The FDA issued a Complete Response Letter rejecting Capricor Therapeutics' application for approval of deramiocel, an allogeneic cell therapy for cardiomyopathy in Duchenne muscular dystrophy (DMD). The agency cited insufficient substantial evidence of effectiveness, requesting additional clinical data. This setback raises questions about possible shifts in regulatory flexibility under new FDA leadership, following multiple departures of cell and gene therapy officials during the review. Capricor expressed surprise at the decision and plans next steps amid falling stock prices.