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Dyne Therapeutics: FDA Clinical Hold on IND Application for DYNE-251

January 20, 2022

As part of our commitment to the Duchenne muscular dystrophy community to deliver the most up-to-date information, Defeat Duchenne Canada is providing you with the following news regarding Dyne Therapeutics. The U.S. Food and Drug Administration (FDA) announced a clinical hold on the Dyne Therapeutics New Drug (IND) application for DYNE-251 – their exon 51 skipping investigational drug. This is a common occurrence as part of the regulatory process, and Dyne has provided detailed information in the letter below.

We look forward to hearing more in the coming months from this program and hope they can start their first in human trials soon.