Sarepta Therapeutics has recommenced shipments of its gene therapy Elevidys® to ambulatory patients with Duchenne muscular dystrophy following a brief FDA-mandated pause. The reversal comes after the FDA concluded that a third reported patient death in Brazil was unrelated to the therapy. Sarepta continues to pause shipments to non-ambulatory patients amid ongoing safety discussions, including the potential addition of a black box warning for acute liver injury. The company and FDA maintain collaboration to define risk mitigation strategies for patients still on hold.