Posted by Michael Wonder on 23 Jan 2025
Stealth BioTherapeutics announces PDUFA action date extension for elamipretide to treat patients with Barth syndrome
23 January 2025 - New PDUFA action date of 29 April 2025, allows FDA additional time to complete review.
Stealth BioTherapeutics today announced that the US FDA has extended the PDUFA action date for the new drug application for elamipretide, a first in class mitochondria-targeted therapeutic in development for individuals with Barth syndrome.
