Stealth BioTherapeutics Corp
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- Stealth BioTherapeutics Inc. is a commercial-stage biotechnology firm dedicated to the discovery, advancement, and marketing of treatments for conditions stemming from mitochondrial dysfunction. Its flagship therapeutic, FORZINITY™ (elamipretide), received accelerated approval from the U.S. Food and Drug Administration on September 19, 2025, as the first treatment for Barth syndrome to enhance muscle strength in eligible patients. The company is also actively investigating elamipretide for other indications, including dry age-related macular degeneration, primary mitochondrial myopathy, Duchenne muscular dystrophy, and various rare cardiomyopathies. The company's pipeline further includes Bevemipretide (SBT-272), a clinical-stage candidate being explored for rare neurological disorders such as amyotrophic lateral sclerosis and frontotemporal dementia, with a topical ophthalmic formulation under evaluation for dry age-related macular degeneration. Additional product candidates consist of SBT-20 for rare disease indications like peripheral neuropathies, the SBT-550 series, with lead candidate SBT-589 in preclinical development for Friedreich's ataxia, and SBT-255, a novel compound for cardiac and muscle myopathies. Stealth BioTherapeutics was originally incorporated in 2006 in the Cayman Islands, and following its acquisition in November 2022 by a consortium led by Morningside Venture, it transitioned to a privately held entity, with its American Depositary Shares subsequently delisted from Nasdaq. The company now primarily operates from Needham, Massachusetts.
FGR accelerates USA expansion & defence sector exposure with strategic acquisition of MITO® Material Solutions
Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide HCl), the First Therapy for Progressive and Life-limiting Ultra-rare Genetic Disease Barth Syndrome
STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION
Stealth BioTherapeutics to Present at JMP Citizens Life Sciences Conference
STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
Stealth BioTherapeutics to Present at the Baird 2023 Biotech Discovery Series
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Stealth Bio Posts Disappointing Elamipretide Data From Mid-Stage Geographic Atrophy Study
Stealth BioTherapeutics to Present at Upcoming March Investor Conferences
Stealth BioTherapeutics to Present at Mitochondria-Targeted Drug Development Summit
Stealth BioTherapeutics to Present at 2022 H.C. Wainwright BioConnect Virtual Conference
Stealth BioTherapeutics Corp (MITO) CEO Reenie McCarthy on Q3 2021 Results - Earnings Call Transcript
Stealth Bio Stock Falls On FDA Refusal to File Letter For Barth Syndrome Candidate
Stealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting