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Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Barth Syndrome
June 02, 2021MITO today announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition. -
FDA Grants Rare Pediatric Disease Designation to Elamipretide for Barth Syndrome
March 05, 2020Stealth BioTherapeutics announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth syndrome. -
Stealth BioTherapeutics Announces Positive Results for Elamipretide in Barth Syndrome Open-Label Extension Trial
April 18, 2019Stealth BioTherapeutics announced positive results from the open-label extension of the Phase 2/3 TAZPOWER study of elamipretide ...
Pharma Sources Insight January 2025
