Dyne Therapeutics announced that its Duchenne muscular dystrophy (DMD) exon‑51 candidate met primary endpoints in a pivotal/registrational study and plans to pursue an accelerated FDA filing. The Phase 1/2 Deliver registrational expansion showed statistically significant increases in dystrophin expression, with adjusted mean levels reported above historical comparators, and functional improvements across multiple motor endpoints. The company emphasized a favorable safety profile and said it will submit for accelerated approval in the second quarter of next year, targeting a potential 2027 launch. Dyne also disclosed organizational expansion in medical, commercial and chemistry‑manufacturing teams to support a rapid regulatory push. If approved, the therapy would compete directly with existing exon‑skipping drugs but with materially higher dystrophin expression in treated patients, according to Dyne’s data. The company positions the result as a potential transformational therapy for the ~13% of DMD patients amenable to exon‑51 skipping.