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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