Dyne Therapeutics Announces Breakthrough Therapy Designation For DYNE-251

(RTTNews) - Dyne Therapeutics (DYN) announced the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of patients with Duchenne muscular dystrophy, amenable to exon 51 skipping. The designation is based on data from the DELIVER clinical trial.

Dyne anticipates a potential BLA submission for U.S. Accelerated Approval in early 2026. Dyne continues to pursue approval pathways outside of the U.S. for DYNE-251 in patients with DMD with a confirmed mutation amenable to exon 51 skipping.

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