sarepta muscular dystophy death FDA gene therapy.

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday it would comply with a Food and Drug Administration request to halt distribution of Elevidys. The decision comes just days after the company rebuffed FDA regulators in an extremely unusual decision. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy. The fatal muscle-wasting disease affects boys and young men, resulting in early death. Company shares continued to slide in early trading Tuesday morning.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy. The Food and Drug Administration made the request Friday after the confirmation of a third death receiving one of its treatments for muscular dystrophy. The company’s decision not to comply is highly unusual. The FDA says officials met with Sarepta executives and requested the halt in sales. Sarepta says in a statement that its scientific review showed no new safety concerns for younger patients with Duchenne’s muscular dystrophy. The company said it plans to keep the drug, Elevidys, available for those patients.