Stealth Biotherapeutics

141 articles with Stealth Biotherapeutics

• 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.

• 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 and Stealth Bio Advance Novel Therapeutics in ALS

  11/1/2022

  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.

• 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. 

• 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.

• 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.

• 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.

• 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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  FDA Agrees to Meet with Stealth on Barth Syndrome Drug

  6/14/2022

  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.

• 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.

• 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.

• Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic Mitochondrial DNA Depletion Syndrome

  5/31/2022

  Orphan drug designation applies to patients with primary mitochondrial myopathy due to nuclear DNA mutations (nPMM) in the NuPower Phase 3 clinical trial.

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  Clinical Catch-Up: 3's the Charm for Pfizer-BioNTech Vaccine in Kids & More

  5/30/2022

  A roundup of last week's top clinical trial announcements and news, including updates from Pfizer, BioNTech, Ocugen and more.

• Stealth BioTherapeutics Announces Data from the Phase 2 ReCLAIM-2 Study of Elamipretide in Geographic Atrophy at the Clinical Trials at the Summit Meeting 2022

  5/23/2022

  Stealth BioTherapeutics Corp announced new data from the ReCLAIM-2 study of elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD) at the Clinical Trials at the Summit meeting in Lake Tahoe, Nevada.

• Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy

  5/12/2022

  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 today that the US Food and Drug Administration Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Duchenne muscular dystrophy (DMD). 

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  Stealth Clinches Orphan Drug Designation in DMD

  5/12/2022

  Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.

• STEALTH BIOTHERAPEUTICS ANNOUNCES DATA FROM RECLAIM-2 PHASE 2 TRIAL OF ELAMIPRETIDE IN GEOGRAPHIC ATROPHY

  5/2/2022

  Stealth BioTherapeutics today announced top-line data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration. 

• Stealth BioTherapeutics Announces $8.5 Million in Equity Financings

  4/11/2022

  Stealth BioTherapeutics Corp today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor to purchase in a registered direct offering 5,583,028 American Depositary Shares.

• Stealth BioTherapeutics Announces New SBT-272 Data and Trial Initiation

  3/30/2022

  Stealth BioTherapeutics Corp (Nasdaq: MITO), announced today the presentation of new SBT-272 preclinical data at the Mitochondrial Biochemistry in Health and Disease Symposium in Breckenridge, CO and dosing of the first subject in its Phase 1 clinical trial of SBT-272.

• Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for the Treatment of Friedreich's Ataxia

  3/28/2022

  Stealth BioTherapeutics Corp announced today that the US Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Friedreich's ataxia.