Dyne Therapeutics Shares Rise Premarket as DMD Study Gets FDA Nod

By Colin Kellaher

Shares of Dyne Therapeutics Inc. jumped in premarket trading Tuesday after the Food and Drug Administration lifted a clinical hold on the company's plans for a Phase 1/2 study of DYNE-251 in certain patients with Duchenne muscular dystrophy, or DMD.

Dyne shares, which closed Friday at $7.20, were recently up 11% to $8 in light premarket trading.

The Waltham, Mass., clinical-stage company targeting muscle diseases said it expects to begin dosing in the study evaluating DYNE-251 in patients with DMD with mutations amenable to skipping exon 51 in mid-2022.

The FDA in January placed the hold on Dyne's application to begin the study, with the agency requesting additional clinical and non-clinical information for DYNE-251.

DMD, a rare, fatal neuromuscular genetic disease that occurs in roughly one in every 3,500 to 5,000 males, is caused by a change or mutation in the gene that encodes instructions for dystrophin, a protein found in muscle cells. There is no cure for DMD, and currently approved therapies provide limited benefit, Dyne said.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 05, 2022 08:17 ET (12:17 GMT)

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