After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is considering whether to halt the distribution of Elevidys, the company’s flagship gene therapy for Duchenne Muscular Dystrophy (DMD).

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and Gilead’s HIV drug Sunlenca.

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new FDA leadership’s much-touted support for cell and gene therapies against rare diseases.

The FDA has come up with a series of ... some added regulatory context on troublesome issues like the added threat of adverse ... before green-lighting the drug. But with Sarepta, ...

Sarepta didn't think it possible that the drug would be so beneficial. Yet, to FDA bureaucrats, actually walkingdoesn't matter, but the walking distance does, which the FDA argues is insigificant.