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 josh.beckerman@wsj.com
(END) Dow Jones Newswires
June 20, 2024 19:05 ET (23:05 GMT)
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