Sarepta Soars After FDA Says Some Patients Can Get Elevidys (1)

July 29, 2025, 1:47 PM UTC

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

The Food and Drug Administration’s sudden turnabout Monday appeared to end a major threat to Sarepta, as Elevidys is its biggest source of revenue. The news came 10 days after the FDA requested that the company pause all shipments of the drug following three deaths that were linked to its gene therapies. The company initially refused, then relented a few days later.

The FDA’s move also comes after pressure from patient ...

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