Capricor’s resubmitted biologics license application for Deramiocel faced a negative advisory committee recommendation, with the FDA Cellular, Tissue, and Gene Therapies Advisory Committee voting 9–3 that available evidence from the Phase III HOPE-3 trial did not provide substantial evidence of effectiveness for cardiomyopathy in Duchenne muscular dystrophy. The committee’s concerns followed an earlier negative FDA evaluation of the resubmission and focused on endpoint achievement and analysis plan issues, including questions around hypersensitivity rates and the updated statistical analysis plan timing. The vote is expected to influence the FDA decision timeline set under PDUFA, with the next agency determination due Aug. 22, making Deramiocel’s regulatory path more uncertain after the adcomm outcome.