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Dyne Therapeutics's Duchenne Muscular Dystrophy Therapy Receives FDA Breakthrough Therapy Tag
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Dyne Therapeutics's Duchenne Muscular Dystrophy Therapy Receives FDA Breakthrough Therapy Tag
Aug 4, 2025 5:24 AM

08:05 AM EDT, 08/04/2025 (MT Newswires) -- Dyne Therapeutics ( DYN ) said Monday that the US Food and Drug Administration has granted breakthrough therapy designation to its experimental therapy, DYNE-251, for treating certain patients with Duchenne muscular dystrophy.

The company said the designation, which helps speed up the development and review of treatments showing significant improvement over existing options for a serious condition, was given based on its ongoing phase 1/2 trial.

Shares of the company were up 3% in Monday's premarket activity.

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