MITO - Stealth Bio rises on pre-NDA meeting for candidate targeting rare heart condition

Clinical-stage biotech Stealth BioTherapeutics (NASDAQ:MITO) added ~14% in the pre-market Tuesday after the company announced that the FDA granted its request for a meeting that will potentially lead to approval of its lead candidate elamipretide in ultra-rare disorder Barth Syndrome. Last year, the FDA declined to file the company’s marketing application for elamipretide for the condition, characterized by cardiac abnormalities. However, Stealth (MITO) requested a Type B pre-NDA meeting to discuss additional data from patients treated with elamipretide over 3.5 years in the open-label extension period of a mid-stage TAZPOWER trial. The FDA accepted the request, and the company expects that the meeting with the FDA Division of Cardiology and Nephrology to take place in 3Q 2022. “The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome,” Stealth (MITO) added.

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Stealth Bio rises on pre-NDA meeting for candidate targeting rare heart condition