NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that […]
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Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome USA – English USA – English
Advisory Committee Voted 10 to 6 in Favor, Concluding that Elamipretide is Effective for the Treatment of Barth Syndrome Elamipretide NDA Received Priority Review with a PDUFA Action Date of January 29, 2025 If Approved, Elamipretide Would […]
Stealth BioTherapeutics Announces FDA Advisory Committee Meeting to Review Elamipretide for Barth Syndrome Treatment
Meeting Scheduled with Cardiovascular and Renal Drugs Advisory Committee on October 10, 2024 NEEDHAM, Mass., Sept. 9, 2024 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage biotechnology company focused on the discovery, development […]










