Stealth BioTherapeutics Awaits FDA Decision on Elamipretide for Barth Syndrome on Tuesday

Stealth BioTherapeutics awaited a response from the Food and Drug Administration (FDA) on Tuesday regarding its marketing application for elamipretide as a treatment for Barth syndrome. The company anticipated the FDA’s decision concerning the potential approval of the drug. Elamipretide is Stealth BioTherapeutics’ investigational drug. The company seeks approval for it to treat Barth syndrome, a rare genetic disorder. The FDA’s decision on the marketing application represents a key step in the regulatory process for the potential new therapy.

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Date: April 29, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後