Capricor Therapeutics received a Complete Response Letter from the FDA rejecting its Biologics License Application for deramiocel, a cell therapy targeting cardiomyopathy in Duchenne muscular dystrophy patients. The FDA cited insufficient evidence of effectiveness and unresolved Chemistry, Manufacturing and Controls (CMC) issues. The decision marks a departure from previous regulatory flexibility in gene and cell therapies, affecting Capricor’s stock negatively and delaying later stage data readouts.