Capricor Shares Plunge After FDA Says DMD Therapy Lacks Efficacy Ahead of Advisory Committee Meeting
Capricor Therapeutics (CAPR) shares plunged up to 70% on July 27, 2026, after the FDA issued briefing documents ahead of an advisory committee meeting signaling serious doubts about the efficacy of its Duchenne muscular dystrophy (DMD) cardiomyopathy therapy, deramiocel.
The FDA concluded that Capricor’s data do not provide substantial evidence of effectiveness and that the benefit-risk assessment for deramiocel appears unfavorable, raising the risk of another rejection following a prior July 2025 complete response letter.
The agency criticized Capricor’s post hoc changes to the primary endpoint analysis methodology in the HOPE-3 Phase 3 trial and expressed skepticism that adequate amounts of the intravenously delivered cell therapy actually reached cardiac tissue to produce meaningful clinical benefit.
Capricor strongly disagrees with the FDA’s characterization, arguing that the HOPE-3 trial met its primary and key secondary endpoints under its final statistical analysis plan, and the company plans to present its case at the Cellular, Tissue, and Gene Therapies Advisory Committee meeting on July 29, 2026.
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