Stealth BioTherapeutics (MITO) Announces Elamipretide NDA Submission
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Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
August 24, 2021 7:30 AM EDTBOSTON, Aug. 24, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for elamipretide, the company's lead product candidate, for the treatment of Barth syndrome, an ultra-rare genetic condition with no FDA- or EMA-approved therapies.
