Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023.
Michael Nagle | Bloomberg | Getty Images
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk.
The Food and Drug Administration will request that the company voluntarily stop all shipments of the treatment, Elevidys, a person familiar with the matter told CNBC.
Sarepta told CNBC it had not heard from the FDA.
Separately, FDA Commissioner Marty Makary told Bloomberg News the agency is considering whether the company’s gene therapy should stay on the market.
The FDA has been investigating two patient deaths tied to Elevidys. The company also reported a third death tied to a separate experimental gene therapy.
The company’s stock has now fallen more than 87% this year.
— CNBC’s Angelica Peebles contributed to this report
This story is developing. Please check back for updates.
