Stealth BioTherapeutics’ Barth Syndrome NDA Receives Priority Review Designation Press Release / May 7, 2024June 3, 2024
Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome Press Release / April 8, 2024June 3, 2024
Stealth BioTherapeutics Presents Data of Novel Compound, SBT-589, in Friedreich’s Ataxia Cardiac Models at the Wellcome Trust Mitochondrial Medicine Conference Press Release / March 19, 2024June 3, 2024
Stealth BioTherapeutics CEO Reenie McCarthy Highlights Opportunities and Challenges in Ultra-Rare Disease Drug Development at World Orphan Drug Congress USA Event / June 14, 2023June 3, 2024
Stealth BioTherapeutics Enters into Exclusive Licensing Agreement with Pharmanovia to Commercialize Elamipretide for the Treatment of Barth Syndrome in Europe and Key Global Territories Press Release / May 30, 2023June 3, 2024
Stealth BioTherapeutics to Present Overview of Elamipretide Clinical Development Program in Barth Syndrome at the 2023 American College of Medical Genetics Meeting Press Release / March 9, 2023June 3, 2024
Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome Press Release / June 14, 2022June 3, 2024
Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic Mitochondrial DNA Depletion Syndrome Press Release / May 31, 2022June 3, 2024
Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy Press Release / May 12, 2022June 3, 2024
Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for the Treatment of Friedreich’s Ataxia Press Release / March 28, 2022June 3, 2024