FDA panel votes against Capricor's Duchenne heart disease therapy

FDA advisers voted 9-3 against approving Capricor’s cell therapy deramiocel for Duchenne-related cardiomyopathy.
The decision is a major setback for what could have been the first treatment aimed specifically at heart disease in Duchenne patients.
FDA reviewers said the evidence and trial analyses were insufficient (noting average normal heart function at baseline); Capricor called the review and reanalysis “shocking.”