The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from Sarepta Therapeutics Inc. should remain on the market.

The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the company’s transparency.