• April 30, 2018

    Press Release Spotlight

    Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Leber’s Hereditary Optic Neuropathy

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    BOSTON – April 30, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy (LHON).

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  • April 9, 2018

    Press Release Spotlight

    Stealth BioTherapeutics Granted Orphan Drug Designation for Elamipretide for Treatment of Barth Syndrome

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    BOSTON – April 9, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with Barth syndrome. “There are… Continue Reading >

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  • March 29, 2018

    Article Spotlight

    MMPOWER Data Published in Neurology

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    We are pleased to share that the prestigious peer-reviewed publication Neurology recently published Phase 1/2 safety and efficacy data from the MMPOWER trial, which studied elamipretide versus placebo in adults with primary mitochondrial myopathy (PMM).1

    Read the full Article

Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Leber’s Hereditary Optic Neuropathy

BOSTON – April 30, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy (LHON).

Stealth BioTherapeutics Granted Orphan Drug Designation for Elamipretide for Treatment of Barth Syndrome

BOSTON – April 9, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with Barth syndrome. “There are… Continue Reading >

MMPOWER Data Published in Neurology

We are pleased to share that the prestigious peer-reviewed publication Neurology recently published Phase 1/2 safety and efficacy data from the MMPOWER trial, which studied elamipretide versus placebo in adults with primary mitochondrial myopathy (PMM).1

Stealth BioTherapeutics Completes Enrollment of Study for the Treatment of Barth Syndrome

BOSTON – March 6, 2018 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational therapeutics to treat mitochondrial dysfunction, today announced the completion of enrollment in the TAZPOWER clinical trial, a phase 2/3, randomized, double-blind, placebo-controlled crossover study to evaluate the effects of daily treatment with elamipretide in 12 patients with genetically confirmed Barth syndrome. Barth syndrome is a rare and debilitating genetic mitochondrial disease that is estimated to affect one in 200,000 to 400,000 individuals worldwide. There are no treatments approved by the U.S. Food and Drug Administration (FDA).

Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy

BOSTON – December 18, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy (LHON).