An FDA advisory committee voted against Capricor’s deramiocel for Duchenne muscular dystrophy cardiomyopathy, capping a meeting marked by dispute over the statistical framing of the underlying evidence. The decision is advisory, but it often carries weight in agency deliberations. Panelists cited fragile evidence and challenged whether the data showed substantial effectiveness for the requested use case. Capricor’s leadership argued the agency’s review emphasis on a draft statistical analysis plan that did not reflect the original approval application contributed to confusion. Capricor previously faced rejection and is now expected to navigate further FDA steps if it pursues additional submissions or confirmatory work, while the result reverberates across DMD cell therapy expectations.