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The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.

Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need.

Stealth BioTherapeutics Inc. announced today that Reenie McCarthy, Stealth’s Chief Executive Officer, will participate in a fireside chat at the JMP Citizens Life Sciences Conference in New York on Monday, May 13 at 2:30 p.m. ET and participate in 1x1 meetings with investors.

Stealth BioTherapeutics today announced that the U.S. Food and Drug Administration (“FDA”) has now determined that its New Drug Application (“NDA”) for elamipretide for the treatment of Barth syndrome is entitled to a Priority Review designation.

Stealth BioTherapeutics Inc. today announced its participation at key upcoming ophthalmology conferences to discuss the Company’s clinical development efforts in dry age-related macular degeneration (dry AMD), including progression of lead investigational compound elamipretide into Phase 3 trials and development of pipeline compound bevemipretide (SBT-272) as a topical ophthalmic drop.

Stealth BioTherapeutics today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for elamipretide for the treatment of Barth syndrome.

Stealth BioTherapeutics Inc. today announced that it has enrolled and dosed its first patient in the ReNEW trial ( NCT06373731 ) as part of its Phase 3 clinical program for elamipretide in patients with dry age-related macular degeneration (dry AMD).