Capricor Therapeutics receives new PDUFA target date of August 22, 2026 for Deramiocel BLA. Potential first therapy to treat both heart and skeletal muscle damage in Duchenne muscular dystrophy (DMD).
Capricor Therapeutics shares rise 2% after FDA requests clinical trial data for deramiocel, a potential treatment for Duchenne muscular dystrophy, without requiring new studies.
Capricor's (CAPR) deramiocel cell therapy achieved significant skeletal and cardiac improvements in Duchenne muscular dystrophy patients, potentially reversing FDA rejection after July setback.
Capricor's DMD drug (HOPE-3 trial) got key FDA alignment, speeding up the approval process using existing files. Data is expected mid-Q4, with potential approval by mid-2026. Shares jumped 9%.
