Sarepta Says FDA Put Clinical Hold on Duchenne MD Drug, Shares Fall 8%

By Stephen Nakrosis

Shares of Sarepta Therapeutics Inc. dropped in after-hours trading after the company said the U.S. Food and Drug Administration placed a clinical hold on SRP-5051, or vesleteplirsen, a treatment for patients with Duchenne muscular dystrophy.

At 4:12 p.m., shares had fallen 8.95% to trade at $65.39. The stock finished the day's regular session with a 5.14% gain, closing at $71.82.

The company said "the hold in Part B of Study 5051-201, also known as MOMENTUM, follows a serious adverse event of hypomagnesemia."

Sarepta said the U.S. Food and Drug Administration is requesting information on all cases of hypomagnesemia, which is marked by a low level of serum magnesium in the blood. The company said it will respond to the FDA in the next few days.

"The hypomagnesemia was transient and patients' magnesium levels returned to normal following additional supplementation," said Louise Rodino-Klapac, chief scientific officer. She added "globally, we have enrolled approximately half of the planned patients in Part B of MOMENTUM. The study is ongoing, and we remain on track to complete enrollment by the end of the year."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

June 23, 2022 16:46 ET (20:46 GMT)

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