Dyne Therapeutics announced that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study, positioning the company to pursue accelerated approval with the U.S. FDA. The firm said the pivotal results support clinical benefit and safety; Dyne plans regulatory filings based on the dataset. The outcome places Dyne as a competitive late‑stage player in the Duchenne space and could reshape the treatment landscape depending on labeling, patient population, and post‑market commitments. Investors and patient groups will focus on durability, amenability to specific mutations, and manufacturing scale as Dyne advances its submission. Clarification: Accelerated approval allows earlier patient access based on surrogate or intermediate clinical endpoints reasonably likely to predict clinical benefit, often requiring confirmatory post‑approval trials.