FDA staff flags concerns for Capricor's Duchenne heart disease therapy
CAPR•FDA reviewers question evidence for deramiocel
U.S. Food and Drug Administration staff reviewers raised concerns about whether Capricor Therapeutics' CAPR.O cell therapy deramiocel has sufficient evidence of effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy, according to briefing documents released on Monday.
