Stealth BioTherapeutics Inc. (the „Company“ or „Stealth“), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced completion of the mid-cycle review meeting with the U.S. Food and Drug Administration („FDA“) regarding its New Drug Application („NDA“) for elamipretide for the treatment of Barth syndrome. If approved, elamipretide would be the first therapy for Barth syndrome, an ultra-rare, progressive, life-shortening, cardioskeletal disease that affects approximately 150 individuals in the United States. The FDA has confirmed its intent to hold an advisory committee meeting, which the Company expects will occur this fall. The NDA for elamipretide was granted priority review and has been assigned a Prescription Drug User Fee Act („PDUFA“) action date of January 29, 2025.
