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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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.