Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
1. FDA requested a halt to Elevidys shipments after three patient deaths. 2. Sarepta rejected FDA's request, leading to regulatory conflict. 3. FDA revoked designation of AAVrh74 Platform Technology due to safety concerns. 4. Elevidys approval now restricted to ambulatory DMD patients. 5. Sarepta plans to submit new data to re-establish dosing for non-ambulant patients.