All articles tagged with #deramiocel
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.
Shares of Capricor Therapeutics dropped 33% after the FDA rejected its experimental drug deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy, citing insufficient evidence of effectiveness and issues in manufacturing documentation. The company plans to continue testing with upcoming results from ongoing studies that could support future approval efforts.
The FDA rejected Capricor Therapeutics' application for its cell therapy deramiocel aimed at treating Duchenne muscular dystrophy, citing insufficient evidence of effectiveness and requesting more clinical data.