Capricor’s resubmitted biologics license application for deramiocel (cardiosphere-derived cell therapy) faced a negative advisory outcome, with the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recommending against approval. The committee’s 9–3 vote concluded that evidence from the Phase 3 HOPE-3 trial did not provide substantial proof of effectiveness. The report tied the concerns to endpoints and statistical approach, including discussion of hypersensitivity events and the company’s failure to submit an updated statistical analysis plan ahead of the resubmission. FDA reviewers had previously assessed that submitted HOPE-3 and HOPE-2 data did not meet the substantial evidence threshold. For the cell therapy market, the decision highlights how evidentiary standards and trial analysis mechanics can still derail programs even when preclinical rationales and prior signals are compelling. The advisory vote also increases attention on the remaining FDA review steps ahead of the Prescription Drug User Fee Act decision date.