Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome

Stealth BioTherapeutics announces FDA acceptance of New Drug Application for elamipretide, a potential treatment for Barth syndrome, supported by positive Phase 3 data. The FDA plans to hold an advisory committee meeting to discuss the application. Elamipretide has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations.