Stealth Biotherapeutics
123 Highland Ave, Suite 201
Needham
Massachusetts
02494
United States
Tel: (617) 600-6888
Website: http://www.stealthbt.com/
150 articles about Stealth Biotherapeutics
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STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
4/8/2024
Stealth BioTherapeutics today announced that the U.S. Food and Drug Administration ("FDA") has accepted for filing its New Drug Application ("NDA") for elamipretide for the treatment of Barth syndrome.
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Stealth BioTherapeutics Presents Data of Novel Compound, SBT-589, in Friedreich's Ataxia Cardiac Models at the Wellcome Trust Mitochondrial Medicine Conference
3/19/2024
Stealth BioTherapeutics Inc. announced today the presentation of new SBT-589 data demonstrating cardioprotective effects across pre-clinical models of Friedreich's ataxia (FA).
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Stealth BioTherapeutics to Present at the Baird 2023 Biotech Discovery Series
12/4/2023
Stealth BioTherapeutics Inc. today announced that Reenie McCarthy , Chief Executive Officer, and Brian Blakey , Chief Business Officer, will participate in a fireside chat at the Baird Biotech Discovery Series on Tuesday, December 5, 2023, at 11:30 AM ET.
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Stealth BioTherapeutics to Present at the 2023 Ophthalmology Innovation Source Summit
11/28/2023
Stealth BioTherapeutics Inc. today announced that Reenie McCarthy , Chief Executive Officer, will participate at OIS XIII: Ophthalmology Innovation Summit (OIS) taking place in San Diego, California on Saturday, December 2, at 11:05 AM PT.
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Stealth BioTherapeutics Completes Target Enrollment in Global Phase 3 NuPOWER Trial in Patients with Primary Mitochondrial Myopathy
9/11/2023
Stealth BioTherapeutics Inc. today announced its achievement of target enrollment in the NuPOWER (SPIMD-301) study in patients with primary mitochondrial myopathy (PMM).
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Stealth BioTherapeutics Awarded Grant from The Michael J. Fox Foundation to Support Development of SBT-272 in Parkinson's Disease
8/9/2023
Stealth BioTherapeutics announced that The Michael J. Fox Foundation for Parkinson's Research awarded a research grant to evaluate Stealth's mitochondria-targeted molecule, SBT-272, for Parkinson's disease.
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Stealth BioTherapeutics CEO Reenie McCarthy Highlights Opportunities and Challenges in Ultra-Rare Disease Drug Development at World Orphan Drug Congress USA
6/14/2023
Stealth BioTherapeutics Inc. provided key takeaways from a presentation by Reenie McCarthy, the Company's Chief Executive Officer, at the World Orphan Drug Congress USA, held May 23-25 in Washington, D.C.
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Stealth BioTherapeutics Announces Positive End-of-Phase 2 Meeting with FDA on the Development of Elamipretide in Patients with Dry Age-related Macular Degeneration
6/12/2023
Stealth BioTherapeutics Inc. announced the successful and favorable outcomes of an end-of-phase 2 meeting with the U.S. Food and Drug Administration for elamipretide, its lead drug candidate for the treatment of dry age-related macular degeneration.
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Stealth BioTherapeutics Enters into Exclusive Licensing Agreement with Pharmanovia to Commercialize Elamipretide for the Treatment of Barth Syndrome in Europe and Key Global Territories
5/30/2023
Stealth BioTherapeutics Inc. today announced their entry into an exclusive licensing agreement whereby Pharmanovia will commercialize elamipretide, Stealth's lead investigational product candidate, in Europe and other key global territories for the treatment of Barth syndrome, an ultra-rare life-threatening cardiac condition caused by mitochondrial cardiolipin deficiency for which there are currently no approved treatments.
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Stealth BioTherapeutics to Present Overview of Elamipretide Clinical Development Program in Barth Syndrome at the 2023 American College of Medical Genetics Meeting
3/9/2023
Stealth BioTherapeutics Inc. today announced that the company will present an overview of the elamipretide clinical development program in Barth syndrome at the 2023 American College of Medical Genetics Meeting, to be held March 14-18, 2023 in Salt Lake City, Utah.
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Stealth BioTherapeutics Corp Announces Completion of Merger
11/16/2022
Stealth BioTherapeutics Corp announced the completion of the merger with Stealth Merger Sub Limited.
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Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio's SBT-272 was granted Orphan Drug designation by the FDA.
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Stealth BioTherapeutics Announces SBT-272 Data Updates and Orphan Drug Designation for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
11/1/2022
Stealth BioTherapeutics Corp today announced encouraging Phase 1 data on the safety and tolerability of SBT-272, a next-generation small molecule designed to reach therapeutic concentrations in the brain and to restore mitochondrial structure and function.
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Stealth BioTherapeutics Corp to Hold Extraordinary General Meeting of Shareholders
10/7/2022
Stealth BioTherapeutics Corp, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that it has called an extraordinary general meeting of shareholders, to be held at 9:30 a.m. on November 15, 2022.
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Stealth BioTherapeutics Announces Departure of Chief Financial Officer
9/30/2022
Stealth BioTherapeutics Corp announced that Robert Weiskopf, Stealth's chief financial officer, is leaving the company effective September 30, 2022.
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STEALTH BIOTHERAPEUTICS ANNOUNCES RECEIPT OF NON-COMPLIANCE NOTICE FROM NASDAQ
7/11/2022
Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that it received a letter from the Listing Qualifications department of The Nasdaq Stock Market LLC.
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Stealth BioTherapeutics Corp Announces Receipt of Preliminary Non-Binding Proposal
6/27/2022
Stealth BioTherapeutics Corp announced today that its Board of Directors (the "Board") has received a preliminary non-binding proposal letter dated June 24, 2022 (the "Proposal Letter") from Morningside Venture (I) Investments Ltd. for itself and on behalf of its affiliates ("Morningside") and J. Wood Capital Advisors LLC ("J. Wood Capital") to acquire all outstanding ordinary shares.
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On Tuesday, Stealth Biotherapeutics announced that it plans to meet with the FDA to discuss a potential NDA for its therapeutic, elamipretide, which is intended to treat Barth syndrome.
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Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome
6/14/2022
Type B meeting scheduled with FDA Division of Cardiology and Nephrology.
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Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium
6/8/2022
Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium.