FDA sets new PDUFA date for Capricor's Deramiocel therapy
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Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA
March 10, 2026 9:25 AM EDTDeramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophyBLA supported by positive pivotal HOPE-3 Phase 3 results, including achievement of the primary endpoint and all Type I error-controlled secondary endpointsPDUFA target action date set for August 22, 2026; Company expects to be eligible for a Priority Review Voucher upon potential approval
SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) --... More
