Tag: Stealth BioTherapeutics

Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome

Type B meeting scheduled with FDA Division of Cardiology and Nephrology Company plans to discuss new clinical data that may inform a potential NDA submission BOSTON, June 14, 2022 /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, […]

Stealth BioTherapeutics Receives Refusal to File Letter from the FDA

BOSTON, Oct. 20, 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 that it received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding Stealth’s New Drug Application […]

Stealth BioTherapeutics Presents Positive Elamipretide Data in Pediatric Cardiology at International Society for Heart Research North American Section Meeting 2021

Elamipretide data demonstrated improvement in mitochondrial function in pediatric cardiomyopathy BOSTON, Sept. 28, 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, announced today the presentation of positive elamipretide data showing improvements in mitochondrial respiration […]