At the FDA's request, delandistrogene moxeparvovec (Elevidys), the only approved gene therapy for Duchenne muscular dystrophy, will carry a black box warning for acute liver injury and acute liver failure, drugmaker Sarepta Therapeutics said.

Sarepta Therapeutics is facing a challenging period after the deaths of two patients who received its Columbus-invented gene therapy for Duchenne muscular dystrophy. Sarepta opens Columbus R&D center,