21 August 2025 - - Stealth BioTherapeutics announced today that the US FDA has accepted for review the resubmission of the new drug application for elamipretide for the treatment of Barth syndrome. 

While the FDA considers the resubmission a complete, class 2 response with a 6 month user fee goal date of 15 February 2026, the agency has advised the Company that its planned goal date is 26 September 2025.

Read Stealth BioTherapeutics press release