Capricor Therapeutics issued a regulatory update on its Biologics License Application for Deramiocel — an investigational cell therapy for Duchenne muscular dystrophy — following FDA review of HOPE‑3 topline data. The company outlined next steps for its BLA based on the agency’s feedback and the HOPE‑3 dataset, noting ongoing engagement with regulators as it refines the submission package. Capricor framed the update as part of an accelerated pathway toward potential approval for a rare‑disease cell therapy.