Sarepta Shares Jump After FDA Approves Updated Elevidys Label
1. FDA issues Boxed Warning for Elevidys gene therapy, citing liver injury risks. 2. Usage restricted to ambulatory DMD patients aged four or older. 3. Voluntary halt of therapy for non-ambulatory patients following fatal incidents. 4. Sarepta stock increased by 5.56% on FDA announcement after prior 50% drop. 5. New safety guidance and Medication Guide released for patients and caregivers.