Posted by Michael Wonder on 18 Aug 2025
Stealth BioTherapeutics resubmits new drug application for elamipretide for the treatment of Barth syndrome
18 August 2025 - Stealth BioTherapeutics today announced the resubmission of a new drug application to the US FDA for Barth syndrome.
As directed by the FDA in its May 2025 complete response and subsequent correspondence, the resubmission contains no new clinical efficacy data, a minor safety update, and confirmation that previously cited manufacturing deficiencies were resolved by FDA, which determined in July that the facility remains in compliance.
