FDA Panel Votes 9-3 Against Capricor’s Duchenne Heart Therapy Over Weak Evidence
Final decision due Aug. 22.
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Capricor Shares Plunge After FDA Briefing Documents Raise Doubts on Deramiocel
FDA briefing documents for Capricor’s deramiocel question effectiveness and highlight safety risks ahead of the July 29 advisory committee.
Capricor Shares Fall as FDA Schedules Advisory Committee for Deramiocel
Capricor Therapeutics stock fell after the Food and Drug Administration set a July 29 review of its DMD therapy; a decision is due Aug. 22.
FDA Lifts Rejection and Schedules August 2026 Review for Deramiocel
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 Stock Jumps as FDA Moves Forward with Rare Disease Treatment Review
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 DMD Therapy Shows Major Promise in Phase 3 Trial
Capricor's (CAPR) deramiocel cell therapy achieved significant skeletal and cardiac improvements in Duchenne muscular dystrophy patients, potentially reversing FDA rejection after July setback.