Stealth BioTherapeutics Corp - ADR

Stealth BioTherapeutics Corp. is a clinical-stage biotechnology company, which engages in the discovery, development, and commercialization of therapies for diseases involving mitochondrial dysfunction. The company was founded on April 3, 2006 and is headquartered in Needham, MA.

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Stealth is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction. Mitochondria, found in nearly every cell in the body, are the body's main source of energy production and are critical for normal organ function. The company was founded in 2007 and is based in Newton, Massachusetts, United States.

Barth Syndrome is an Ultra-rare, Progressive, Life-Shortening, Cardioskeletal Disease that Affects Approximately 150 Individuals in the United States If Approved, Elamipretide Would Become the First Approved Therapy for Barth Syndrome NEEDHAM, Mass. , May 7, 2024 /PRNewswire/ -- Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration ("FDA") has now determined that its New Drug Application ("NDA") for elamipretide for the treatment of Barth syndrome is entitled to a Priority Review designation.

STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION

NEEDHAM, Mass. , May 6, 2024 /PRNewswire/ -- Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that Reenie McCarthy, Stealth's Chief Executive Officer, will participate in a fireside chat at the JMP Citizens Life Sciences Conference in New York on Monday, May 13 at 2:30 p.m.

Stealth BioTherapeutics to Present at JMP Citizens Life Sciences Conference

Barth Syndrome is an Ultra-rare, Progressive, Life-Shortening, Cardioskeletal Disease that Affects Approximately 150 Individuals in the United States If Approved, Elamipretide Would Become the First Approved Therapy for Barth Syndrome NEEDHAM, Mass. , April 8, 2024 /PRNewswire/ -- Stealth BioTherapeutics , a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, 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.

STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME

NEEDHAM, Mass. , Dec. 4, 2023 /PRNewswire/ -- Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, 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.

Stealth BioTherapeutics to Present at the Baird 2023 Biotech Discovery Series

BOSTON , Nov. 16, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO) (the "Company" or "Stealth BioTherapeutics"), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the completion of the merger (the "Merger") with Stealth Merger Sub Limited, an exempted company with limited liability incorporated under the law of the Cayman Islands ("Merger Sub"), pursuant to the previously announced Agreement and Plan of Merger, dated as of July 31, 2022 (the "Merger Agreement"), among the Company, Stealth Parent Limited, an exempted company with limited liability incorporated under the law of the Cayman Islands ("Parent") and Merger Sub, a wholly-owned subsidiary of Parent, and the plan of merger required to be filed with the Registrar of Companies of the Cayman Islands (the "Plan of Merger"). In the Merger, Merger Sub merged with and into the Company, with the Company continuing as the surviving company.

Stealth BioTherapeutics Corp Announces Completion of Merger

SBT-272 Phase 1 safety and tolerability data support further clinical development SBT-272 was neuroprotective and reduced neuroinflammation in ALS preclinical model SBT-272 Granted Orphan Drug Designation for Treatment of ALS BOSTON , Nov. 1, 2022 /PRNewswire/ -- 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, 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.  The Company also announced that positive preclinical data demonstrating that treatment with SBT-272 provided neuroprotection of upper motor neurons harboring ALS pathology will be presented today at the Northeast Amyotrophic Lateral Sclerosis (NEALS) conference in Clearwater, FL.

Stealth BioTherapeutics Announces SBT-272 Data Updates and Orphan Drug Designation for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

BOSTON , Oct. 7, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO) ("Stealth" or the "Company"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that it has called an extraordinary general meeting of shareholders (the  "EGM"), to be held at 9:30 a.m. (New York City time) on November 15, 2022, at Foley & Lardner LLP, 111 Huntington Ave Suite 2600, Boston, MA 02199, to consider and vote on, among other matters, the proposal to authorize and approve the previously announced agreement and plan of merger, dated as of July 31, 2022 (the "Merger Agreement"), between the Company and Stealth Parent Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands ("Parent"), and Stealth Merger Sub Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands and a wholly-owned subsidiary of Parent ("Merger Sub"), and the plan of merger required to be filed with the Registrar of Companies of the Cayman Islands (the "Plan of Merger") and the transactions contemplated thereby, including the Merger (as defined below).

Stealth BioTherapeutics Corp to Hold Extraordinary General Meeting of Shareholders

BOSTON , Sept. 30, 2022 /PRNewswire/ -- 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, today announced that Robert Weiskopf, Stealth's chief financial officer, is leaving the company effective September 30, 2022.

Stealth BioTherapeutics Announces Departure of Chief Financial Officer

BOSTON , Sept. 15, 2022 /PRNewswire/ -- 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, today announced that the company is participating in upcoming events to discuss challenges and opportunities in ultra-rare disease drug development.

Stealth BioTherapeutics to Participate in Upcoming Ultra-Rare Disease Events

BOSTON , Aug. 1, 2022 /PRNewswire/ -- 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 it has entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with Stealth Parent Limited, an exempted company with limited liability incorporated under the law of the Cayman Islands ("Parent"), and Stealth Merger Sub Limited, an exempted company with limited liability incorporated under the law of the Cayman Islands and a wholly-owned subsidiary of Parent ("Merger Sub"), to be acquired by a consortium of investors led by Morningside Venture (I) Investments Ltd. for itself and on behalf of its affiliates ("Morningside") and J.

Stealth BioTherapeutics Corp Enters Definitive Agreement for Going Private Transaction

BOSTON , July 11, 2022 /PRNewswire/ -- 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 ("Nasdaq") on July 7, 2022 notifying the Company that, based upon the Company's continued non-compliance with the minimum bid price and market value of listed securities requirements, as set forth in Nasdaq Listing Rules 5450(a)(1) and 5450(b)(2), the Company's securities would be delisted from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the "Panel"). Pursuant to the letter, unless the Company requests an appeal, trading of the Company's American Depositary Shares will be suspended at the opening of business on July 18, 2022, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's securities from listing and registration on The Nasdaq Stock Market.

STEALTH BIOTHERAPEUTICS ANNOUNCES RECEIPT OF NON-COMPLIANCE NOTICE FROM NASDAQ

BOSTON , June 27, 2022 /PRNewswire/ -- 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 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.

Stealth BioTherapeutics Corp Announces Receipt of Preliminary Non-Binding Proposal

Type B meeting scheduled with FDA Division of Cardiology and Nephrology Company plans to discuss new clinical data that may inform a potential NDA submission BOSTON , June 14, 2022 /PRNewswire/ -- 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, today 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. In October 2021, the FDA refused to file the Company's NDA for the treatment of Barth Syndrome.

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

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Stealth BioTherapeutics Corp (NASDAQ: MITO) presented new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology. TDP-43 pathology plays a significant role in amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).

Why Stealth BioTherapeutics Shares Are Surging Today?

SBT-272 improved neuronal health, superior to other approved and investigational agents Phase 1 study to evaluate safety and tolerability of SBT-272 in healthy volunteers is underway BOSTON , June 8, 2022 /PRNewswire/ -- 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 the presentation of new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology, which plays a significant role in both amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The data were presented at the Keystone Neurodegeneration Symposium in Keystone, CO held June 5-9, 2022.

Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium

Orphan drug designation applies to patients with primary mitochondrial myopathy due to nuclear DNA mutations (nPMM) in the NuPower Phase 3 clinical trial NuPOWER Phase 3 trial is currently enrolling patients with multiple clinical trial sites initiated in the United States and Europe BOSTON , May 31, 2022 /PRNewswire/ -- 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, today announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of myopathic mitochondrial DNA depletion syndrome (M-MDS), a designation which applies to patients with nPMM eligible for enrollment in the NuPOWER Phase 3 clinical trial, which is currently enrolling patients at multiple clinical trial sites in the United States and Europe. "We are pleased that EMA has recognized the high unmet need for innovative treatments for this rare genetic condition which significantly limits the quality of life of affected individuals," said Chief Executive Officer Reenie McCarthy.

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

New analysis demonstrates correlation between ellipsoid zone dysfunction and vision BOSTON , May 23, 2022 /PRNewswire/ -- 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 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. The ReCLAIM-2 prespecified analyses demonstrate that elamipretide ameliorated progressive decline, or attenuation, of the mitochondrial rich ellipsoid zone (EZ) layer of the photoreceptors (p2-line improvement in low luminance visual acuity (LLVA) (p=0.04) in patients with GA.

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

Pre-IND meeting request granted by FDA's Division of Neurology I BOSTON , May 12, 2022 /PRNewswire/ -- 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 (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Duchenne muscular dystrophy (DMD).  The company also announced that the FDA's Division of Neurology I has granted its request for a pre-IND meeting to discuss a development path for elamipretide in combination with products within the approved therapeutic class of exon-skipping phosphorodiamidate morpholino oligomers (PMO).

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

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Stealth BioTherapeutics Corp (NASDAQ: MITO) has announced topline data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration.  Although the trial did not meet its primary endpoints, a key secondary.

Stealth Bio Posts Disappointing Elamipretide Data From Mid-Stage Geographic Atrophy Study

Study did not meet primary endpoints of mean change in low luminance visual acuity (LLVA) and geographic atrophy (GA) progression Categorical improvement in LLVA, with >15% of elamipretide-treated patients gaining 2+ lines of vision at Week 48 Elamipretide demonstrated enhanced ellipsoid zone preservation through reduction of progressive attenuation, an important indicator of photoreceptor loss. Company to host conference call and webcast today at 8:30 a.m.

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

BOSTON , April 11, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO) (the "Company"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, 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 (the "Registered ADSs"), representing 66,996,336 ordinary shares of the Company, at a purchase price of $0.6269 per Registered ADS for gross proceeds of approximately $3.5 million, before deducting placement agent fees and other offering expenses payable by the Company. Each ADS represents 12 ordinary shares.

Stealth BioTherapeutics Announces $8.5 Million in Equity Financings

BOSTON , March 30, 2022 /PRNewswire/ -- 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 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. The new data demonstrated behavioral and metabolic improvements with SBT-272 in a mouse model of Huntington's disease.

Stealth BioTherapeutics Announces New SBT-272 Data and Trial Initiation

Phase 2a clinical trial in Friedreich's ataxia has been initiated and is currently recruiting patients BOSTON , March 28, 2022 /PRNewswire/ -- 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 (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Friedreich's ataxia.  A phase 2a investigator-initiated trial evaluating elamipretide for the treatment of Friedreich's ataxia has been initiated at Children's Hospital of Philadelphia (CHOP) under the direction of Dr. David Lynch.

News for Stealth BioTherapeutics Corp - ADR Stock (MITO)