Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and full approval in June 2024. Roche partnered with Sarepta in December 2019, paying $1.15 billion upfront in cash and stock for the right to launch and market Elevidys outside the U.S.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths of two teenage boys.

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed to the regulator's request to temporarily suspend shipments of the Duchenne muscular dystrophy (DMD) gene therapy.

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene moxeparvovec-rokl), the marketed Duchenne muscular dystrophy (DMD) treatment linked to the deaths of two patients this year.