Dyne Therapeutics announced that its next‑generation exon‑skipping therapy for Duchenne muscular dystrophy met its late‑stage study endpoints, positioning the company to submit for regulatory approval. The program targets dystrophin restoration for patients with specific mutations and follows a contentious history for exon‑skipping medicines that produce low levels of protein. Dyne’s readout will invite close regulatory scrutiny given prior failed confirmatory studies for competitors and questions about whether modest dystrophin increases translate to functional benefit. The company will need robust clinical and biomarker data to support its filing and to convince payers of value for a rare disease population.