Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical hold request from the FDA.

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators