FDA Review Challenges the Deramiocel Evidence Package

Company Capricor Therapeutics Event Type Regulatory Review (FDA Advisory Committee Briefing) Modality Allogeneic cardiosphere-derived cell therapy Asset Deramiocel Target Cardiac inflammation and fibrosis modulation Disease Area Duchenne muscular dystrophy cardiomyopathy Summary FDA briefing materials concluded that Capricor’s HOPE-3 study did not meet its prespecified efficacy…