Reported about 16 hours ago
Sarepta Therapeutics announced a return to gene therapy shipments after a pause prompted by FDA concerns regarding patient deaths. The FDA has lifted its hold for young patients with Duchenne’s muscular dystrophy who can still walk, clarifying that a recent death of an 8-year-old was not linked to the therapy. Shares of Sarepta rose significantly post-announcement, signaling improved sales prospects for Elevidys, the first approved gene therapy in the U.S. for this condition, though further safety studies will be required for older patients.
Source: YAHOO