Capricor Therapeutics issued a regulatory update on its Biologics License Application for Deramiocel after the FDA reviewed topline data from the HOPE‑3 study. Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy and the company said the FDA review of HOPE‑3 results informs its BLA strategy. Capricor characterized the update as part of its ongoing engagement with regulators; the firm is positioning Deramiocel as a first‑in‑class cell‑based approach for DMD. The company emphasized next regulatory steps while stakeholders assess implications of the HOPE‑3 readout for approval timelines.