Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

While the FDA has mechanisms to eventually force withdrawal of a drug from market, they are lengthy and involved. Typically, the agency relies on companies voluntarily agreeing to work with it.

The third death of a patient on a Sarepta therapy occurred in a 51-year-old man with limb-girdle muscular dystrophy type 2D/R3 who participated in a phase 1 trial. He had not received Sarepta’s ...

Sarepta Therapeutics rejected the Food and Drug Administration's call to stop shipments of its muscular dystrophy drug. The FDA request came after a third patient in a Phase 1 study died while ...

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second session after plunging 36% on Friday.

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy By Gabrielle Masson Jul 21, 2025 11:36am Sarepta Sarepta Therapeutics Cell & Gene Therapy clinical hold ...

Sarepta Therapeutics has plunged to new lows below $13, down over 35% in recent trading, after rejecting the FDA’s request to voluntarily halt all shipments of Elevidys following a third death ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths ...