Dyne Therapeutics announced that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and that the company plans to seek accelerated FDA approval. Company releases and presentations noted statistically significant increases in dystrophin expression and functional measures compared with placebo in the registrational cohort. Dyne highlighted higher, muscle‑content adjusted dystrophin percentages that exceeded prior exon‑skipping benchmarks and described a favorable safety profile; CEO John Cox said the data 'has the potential to transform the care' for patients amenable to exon 51 skipping. The company intends to file for approval and prepare for a potential early 2027 launch if regulators agree. The readout revives debate over the clinical meaningfulness of dystrophin increases and may prompt regulatory scrutiny on functional endpoints and long‑term benefit claims.