Sarepta Shares Soar 37% Following Expanded Approval for Elevidys

By Josh Beckerman

Shares of Sarepta Therapeutics rose 37% to $169.15 in after-hours trading on Thursday after the Food and Drug Administration approved an expanded indication for its Duchenne muscular dystrophy treatment Elevidys.

The drug was approved for ambulatory and non-ambulatory people, ages 4 and above, with a confirmed mutation in the DMD gene. This includes traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients, the company said.

Under the accelerated-approval program, the FDA clears the use of drugs faster than it normally would and asks companies to conduct follow-up studies.

In December 2019, Sarepta announced a licensing agreement that provided Roche Holding exclusive rights to the drug outside the U.S.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

06-20-24 1905ET