Capricor Advances Deramiocel BLA: FDA Seeks Full HOPE-3 CSR

FDA has requested the full HOPE-3 clinical study report (CSR) and supporting data to address Capricor’s Complete Response Letter for the Deramiocel BLA; Capricor will submit the CSR and updates in February 2026 to support continued FDA review and a new PDUFA date, following HOPE-3 topline data showing significant skeletal muscle and cardiac improvements in Duchenne muscular dystrophy.