08:59 AM EST, 01/21/2025 (MT Newswires) -- Dyne Therapeutics ( DYN ) said Tuesday that the US Food and Drug Administration granted fast-track designation for its experimental therapy, DYNE-101, to treat a genetic neuromuscular disease, myotonic dystrophy type 1.

DYNE-101 is currently being evaluated in the ongoing phase 1/2 trial.

The company said it plans to submit for US accelerated approval in the first half of next year.

Shares of the company were up more than 4% in recent premarket activity.