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 […]
Tag: Stealth BioTherapeutics Inc.
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 […]
