The FDA has resumed review of Capricor Therapeutics’ previously rejected Duchenne muscular dystrophy (DMD) cell therapy after the company submitted additional clinical data. The agency’s decision to restart the review follows Capricor’s provision of new evidence addressing outstanding questions from earlier assessments. Complementing the regulatory development, preclinical research reported that TN‑301 restores muscle and cardiac function in DMD models by modulating HDAC6‑related pathways and improving cytoskeletal dynamics. The preclinical data provide mechanistic context for therapeutic strategies aiming to stabilize muscle membranes and reduce disease progression. Clinical implications: the FDA’s renewed review could accelerate availability of new DMD options if safety and efficacy queries are resolved. Concurrent preclinical advances continue to diversify the field’s therapeutic approaches, from cell therapies to small molecules targeting muscle integrity.