FDA Committee Rejects Capricor's Duchenne Cell Therapy Amid Statistical Dispute on August 02, 2026 adcomm Capricor deramiocel DMD DMD cardiomyopathy HOPE-3 trial Muscular Dystrophy, Duchenne PDUFA SH2D1A gene Statistical Analysis Plan United States Food and Drug Administration +
FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy, deramiocel on July 30, 2026 Blinded briefing documents Capricor Therapeutics deramiocel Hypersensitivity Muscular Dystrophy, Duchenne primary endpoints Statistical Analysis Plan United States Food and Drug Administration +