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 +
Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner on May 06, 2025 Biologics License Application Capricor deramiocel first Market Review [Publication Type] United States Food and Drug Administration +