Dyne Therapeutics, Inc. (DYN) saw its stock surge 5.37% in pre-market trading on Monday following a major regulatory breakthrough for its lead drug candidate. The company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping.

This significant development is based on promising data from the ongoing DELIVER clinical trial. The Breakthrough Therapy Designation is designed to expedite the development and review process of DYNE-251, offering several advantages including enhanced FDA support and accelerated review timelines. This could potentially fast-track the drug's path to market, representing a major milestone for Dyne Therapeutics and patients suffering from DMD.

Investors are reacting positively to this news, as it substantially increases the likelihood of DYNE-251's success and potential market approval. Dyne Therapeutics anticipates submitting a Biologics License Application (BLA) for U.S. accelerated approval in early 2026, with data from the DELIVER registrational expansion cohort expected in late 2025. The company is also pursuing additional approval pathways outside the U.S., potentially expanding the global reach of this promising treatment for DMD patients.