FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome on September 24, 2025 3-Methylglutaconic aciduria type 2 Accelerated Approved Elamipretide Forzinity Infrequent Mitochondrial Diseases Pediatric Disorder Stealth BioTherapeutics United States Food and Drug Administration +
FDA Approves Stealth BioTherapeutics' Forzinity as First Treatment for Barth Syndrome After Rejection and Delay on September 22, 2025 3-Methylglutaconic aciduria type 2 Abnormality of mitochondrial metabolism Accelerated Approved Elamipretide Forzinity Infrequent Stealth BioTherapeutics United States Food and Drug Administration +