An FDA advisory committee voted against approval of Capricor’s deramiocel, a heart-derived cell therapy for Duchenne muscular dystrophy cardiomyopathy, following a contentious review of the Phase 3 HOPE-3 dataset. The panel vote was 9-3, with reviewers citing “very fragile” evidence and a statistical analysis dispute over which version of the statistical analysis plan should govern the efficacy conclusions. Capricor’s CEO Linda Marbán argued the FDA relied on an improper SAP draft, while committee members challenged whether the available evidence showed substantial effectiveness as framed in the voting question. Patient testimony and unmet need themes did not change the committee’s outcome. Separately, a related FDA adcom recap describes the underlying dispute as the agency and company offering sharply different interpretations of clinical endpoints including upper-limb and cardiac function. The FDA is not bound by advisory committee recommendations, but the panel’s decision heightens scrutiny for deramiocel’s resubmission pathway and any next data package.