Stealth BioTherapeutics’ mission is to develop novel therapies to improve the lives of patients living with diseases of mitochondrial dysfunction. Stealth’s commercial product, FORZINITY, was granted accelerated approval by the U.S. Food & Drug Administration (FDA) in September 2025 as the first FDA-approved treatment for Barth syndrome, as well as the first FDA-approved mitochondria-targeted therapeutic. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Stealth is studying elamipretide in additional indications, including dry age-related macular degeneration and primary mitochondrial myopathy, and is developing its second-generation clinical-stage candidate, bevemipretide (SBT-272), for ophthalmic and neurological disease indications.