Stealth BioTherapeutics (MITO) Announces FDA Grants Rare Pediatric Disease Designation for Elamipretide for Treatment of Barth Syndrome

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Go back to Stealth BioTherapeutics (MITO) Announces FDA Grants Rare Pediatric Disease Designation for Elamipretide for Treatment of Barth Syndrome

FDA Grants Rare Pediatric Disease Designation to Stealth BioTherapeutics for Elamipretide for the Treatment of Barth Syndrome

March 3, 2020 7:30 AM EST

BOSTON, March 3, 2020 /PRNewswire/ -- Stealth BioTherapeutics (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition.

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