FDA lifts CRL for Deramiocel BLA; new PDUFA date August 22, 2026

CAPRICOR THERAPEUTICS, INC.

FDA resumed review of Deramiocel BLA for Duchenne muscular dystrophy cardiomyopathy after lifting CRL.
Submission classified as Class 2 resubmission; PDUFA target action date set for August 22, 2026.
BLA supported by positive HOPE-3 Phase 3 trial meeting primary and all secondary endpoints.
Company expects to be eligible for a Priority Review Voucher upon potential approval.
FDA has not identified any review issues in its response to Capricor at this time.

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