• December 18, 2017

    Uncategorized Spotlight

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

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    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).

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  • November 27, 2017

    Press Release Spotlight

    Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome

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    BOSTON – November 27, 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 Barth syndrome. “Fast Track designation is an important milestone which will facilitate… Continue Reading >

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  • November 6, 2017

    Press Release Spotlight

    Stealth BioTherapeutics Initiates Phase 3 Study of Elamipretide in Patients with Primary Mitochondrial Myopathy

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    BOSTON, Nov. 6, 2017 /PRNewswire/ — Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of MMPOWER-3, a Phase 3 study evaluating the efficacy and safety of daily subcutaneous injections of elamipretide in patients with primary mitochondrial myopathy (PMM). MMPOWER-3 will enroll eligible patients who previously participated in RePOWER, an ongoing, prospective, non-interventional study evaluating patients with PMM. 

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  • October 2, 2017

    Press Release Spotlight

    Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Patients with Primary Mitochondrial Myopathy

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    BOSTON – October 2, 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’s (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with primary mitochondrial myopathy (PMM).

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  • August 7, 2017

    Press Release Spotlight

    Stealth BioTherapeutics Announces New Appointments to its Board of Directors

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    BOSTON – August 7, 2017 – Stealth BioTherapeutics Inc. (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced the appointment of three directors to its Board of Directors: Francis W. Chen, Kevin McLaughlin and Edward Owens. Stealth’s Board of Directors now includes five members with extensive experience in biotechnology and business development.

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  • July 24, 2017

    Press Release Spotlight

    Stealth BioTherapeutics Initiates Phase 2/3 Study of Elamipretide in Patients with Barth Syndrome

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    BOSTON – July 19, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of TAZPOWER, a Phase 2/3 study evaluating elamipretide in patients with Barth syndrome. Barth syndrome is a rare genetic mitochondrial disease, caused by mutations in the TAZ gene, and characterized by cardiac abnormalities, skeletal muscle weakness, recurrent infections and delayed growth.

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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).

Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome

BOSTON – November 27, 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 Barth syndrome. “Fast Track designation is an important milestone which will facilitate… Continue Reading >

Stealth BioTherapeutics Initiates Phase 3 Study of Elamipretide in Patients with Primary Mitochondrial Myopathy

BOSTON, Nov. 6, 2017 /PRNewswire/ — Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of MMPOWER-3, a Phase 3 study evaluating the efficacy and safety of daily subcutaneous injections of elamipretide in patients with primary mitochondrial myopathy (PMM). MMPOWER-3 will enroll eligible patients who previously participated in RePOWER, an ongoing, prospective, non-interventional study evaluating patients with PMM. 

Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Patients with Primary Mitochondrial Myopathy

BOSTON – October 2, 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’s (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with primary mitochondrial myopathy (PMM).

Stealth BioTherapeutics Announces New Appointments to its Board of Directors

BOSTON – August 7, 2017 – Stealth BioTherapeutics Inc. (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced the appointment of three directors to its Board of Directors: Francis W. Chen, Kevin McLaughlin and Edward Owens. Stealth’s Board of Directors now includes five members with extensive experience in biotechnology and business development.