Stealth Biotherapeutics Announces FDA Acceptance of New Drug ...
Stealth BioTherapeutics announced FDA acceptance of its NDA for elamipretide, a potential first therapy for Barth syndrome, a rare, life-shortening cardioskeletal disease affecting about 150 in the U.S. Supported by Phase 3 trial data, elamipretide has received multiple FDA designations, aiming to address the urgent unmet need for treatment.
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Stealth Biotherapeutics Announces FDA Acceptance of New Drug ...
Stealth BioTherapeutics announced FDA acceptance of its NDA for elamipretide, a potential first therapy for Barth syndrome, a rare, life-shortening cardioskeletal disease affecting about 150 in the U.S. Supported by Phase 3 trial data, elamipretide has received multiple FDA designations, aiming to address the urgent unmet need for treatment.