Inactive Instrument

Stealth BioTherapeutics Corp

Equities

MITO

US85789A1051

Biotechnology & Medical Research

Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome

June 14, 2022 at 07:25 am EDT

Stealth BioTherapeutics Corp. announced its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth Syndrome. The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome.

The FDA has granted the meeting request and the Company expects this meeting to occur during the third quarter.

Latest news about Stealth BioTherapeutics Corp

Stealth BioTherapeutics Corp Highlights Opportunities and Challenges in Ultra-Rare Disease Drug Development at World Orphan Drug Congress USA	23-06-14	CI
Stealth BioTherapeutics Announces Positive End-Of-Phase 2 Meeting with FDA on the Development of Elamipretide in Patients with Dry Age-related Macular Degeneration	23-06-12	CI
Stealth Biotherapeutics Enters into Exclusive Licensing Agreement with Pharmanovia to Commercialize Elamipretide	23-05-30	CI
Stealth BioTherapeutics Corp(NasdaqGM:MITO) dropped from NASDAQ Composite Index	22-11-16	CI
J. Wood Capital Advisors LLC and Morningside Venture (I) Investments Limited completed the acquisition of 22.5293% stake in Stealth BioTherapeutics Corp.	22-11-15	CI
Stealth BioTherapeutics Corp Announces SBT-272 Data Updates and Orphan Drug Designation for the Treatment of Amyotrophic Lateral Sclerosis	22-11-01	CI
Stealth BioTherapeutics Chief Financial Officer Departs	22-10-03	MT
Stealth BioTherapeutics Corp Announces Departure of Robert Weiskopf as Chief Financial Officer	22-09-30	CI
Stealth BioTherapeutics Corp Agrees to Go Private; Shares Jump	22-08-01	MT
Stealth BioTherapeutics Gets Notice of Potential Delistment From Nasdaq	22-07-12	MT
Stealth BioTherapeutics Receives Non-Binding Proposal by Morningside Venture to Go Private	22-06-27	MT
J. Wood Capital Advisors LLC and Morningside Venture (I) Investments Limited agreed to acquire a 22.5293% stake in Stealth BioTherapeutics Corp for $0.35 million.	22-06-26	CI
Sector Update: Health Care Stocks Climb Pre-Bell Tuesday	22-06-14	MT
Sector Update: Health Care	22-06-14	MT
Stealth BioTherapeutics Gets FDA Meeting on Pre-Application for Potential Barth Syndrome Treatment	22-06-14	MT
Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome	22-06-14	CI
Wall Street Tumbles Pre-Bell; Inflation Data Eyed	22-06-08	MT
Top Premarket Gainers	22-06-08	MT
Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium	22-06-08	CI
Stealth BioTherapeutics Gets European Medicines Agency Orphan Drug Designation for Elamipretide	22-05-31	MT
HC Wainwright Adjusts Stealth BioTherapeutics' Price Target to $1.50 from $4, Keeps Buy Rating	22-05-23	MT
Stealth BioTherapeutics Corp Announces Data from the Phase 2 ReCLAIM-2 Study of Elamipretide in Geographic Atrophy at the Clinical Trials at the Summit Meeting 2022	22-05-23	CI
Stealth BioTherapeutics Gets FDA's Orphan Drug Designation for Duchenne Muscular Dystrophy Drug Candidate; Shares Rise	22-05-12	MT
Wall Street Set for Losses Amid Inflation Worries; Weekly Jobless Claims Rise	22-05-12	MT
Top Premarket Gainers	22-05-12	MT

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Company Profile

Stealth BioTherapeutics Corp is a clinical-stage biotechnology company. The Company is focused on the discovery, development and commercialization of therapies for diseases involving mitochondrial dysfunction. Its clinical product candidate, elamipretide, is a small peptide that targets and binds reversibly to cardiolipin, a structural element of mitochondria, stabilizing the inner mitochondrial membrane under conditions of oxidative stress. This mechanism of action has shown potential clinical benefit in both rare genetic and common age-related ophthalmic and cardiac diseases entailing mitochondrial dysfunction. The Company's second clinical product candidate include SBT-272, for rare neurological diseases involving mitochondrial dysfunction, with a preliminary focus on amyotrophic lateral sclerosis and frontotemporal lobar degeneration. Its clinical product candidate also includes SBT-550 series for rare neurological indications, including Friedreich's ataxia (FRDA).

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