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.

Stealth BioTherapeutics Corp (NASDAQ: MITO) has submitted an elamipretide marketing application to the FDA for Barth syndrome. The submission is based on results from the SPIBA-001 Phase 3 Retrospective Natural History Control Trial, which compared data from the TAZPOWER Phase 2/3 trial's open-label portion to match natural history controls.

Stealth Bio Files US Application For Ultra Rare Genetic Disease Candidate

BOSTON, Aug. 24, 2021 /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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for elamipretide, the company's lead product candidate, for the treatment of Barth syndrome, an ultra-rare genetic condition with no FDA- or EMA-approved therapies. "Children and young adults affected by Barth syndrome are suffering from life limiting, progressive cardiomyopathy, exercise intolerance, and debilitating fatigue for which there are no approved treatment options," said Chief Executive Officer Reenie McCarthy.

Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome

BOSTON, Aug. 23, 2021 /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 United States Patent and Trademark Office has issued patents for Stealth's lead product candidate, elamipretide, in the U.S. covering the treatment of Barth syndrome and Barth syndrome-related cardiomyopathy until February 2034. U.S. Patent Numbers 11,083,771 and 11,083,772, were granted on August 10, 2021, and include claims for the administration of elamipretide for treating Barth syndrome and Barth syndrome-related cardiomyopathy, respectively.

Stealth BioTherapeutics Strengthens IP Portfolio with Issuance of U.S. Patents Covering Elamipretide for Barth Syndrome

BOSTON, Aug. 11, 2021 /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 Reenie McCarthy, CEO, will present at the H.C. Wainwright Ophthalmology Virtual Conference on Tuesday, August 17, 2021 at 7:00 a.m.

Stealth BioTherapeutics to Present at H.C. Wainwright Ophthalmology Virtual Healthcare Conference

Stealth BioTherapeutics Corp (MITO) CEO Irene McCarthy on Q2 2021 Results - Earnings Call Transcript

BOSTON, Aug. 5, 2021 /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 reported financial results for the three months ended June 30, 2021 and announced recent business highlights. "We continue to make important progress on developing elamipretide and our deep pipeline of novel mitochondrial-targeted compounds to address rare and devastating diseases of mitochondrial dysfunction," said Reenie McCarthy, Chief Executive Officer at Stealth.

Stealth BioTherapeutics Reports Second Quarter 2021 Financial Results And Recent Business Highlights

BOSTON, July 30, 2021 /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 it will report second quarter 2021 financial results on Thursday, August 5, before the market opens. Management will host a conference call at 8:30 am ET that day to discuss the financial results and provide a general business update.

Stealth BioTherapeutics to Report Second Quarter Financial Results on Thursday, August 5

Stealth BioTherapeutics (MITO) has been struggling lately, but the selling pressure may be coming to an end soon.

Stealth BioTherapeutics (MITO) Sees Hammer Chart Pattern: Time to Buy?

BOSTON, July 7, 2021 /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 it has joined the Rare Disease Company Coalition, an alliance of life science companies committed to discovering, developing, and delivering rare disease treatments for the patients they collectively serve. "We are thrilled to be a part of the first-of-its-kind Rare Disease Company Coalition, which is focused on supporting rare disease patients through the development of innovative therapeutics," said Reenie McCarthy, Chief Executive Officer at Stealth.

Stealth BioTherapeutics Joins the Rare Disease Company Coalition

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The European Medicines Agency (EMA) has granted orphan drug designation to Stealth BioTherapeutics Corp's (NASDAQ: MITO) elamipretide for Barth syndrome, an ultra-rare genetic condition. Barth syndrome is characterized by cardiac abnormalities, often leading to heart failure and reduced life expectancy, recurrent infections, muscle weakness, and delayed growth.

Stealth BioTherapeutics Stock Surges On Elamipretide's European Orphan Drug Tag for Ultra-Rare Genetic Condition

BOSTON, June 1, 2021 /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 Barth syndrome, an ultra-rare genetic condition. "We are pleased that EMA has recognized, by granting ODD for elamipretide for Barth syndrome, the high unmet need for innovative treatments for this ultra-rare genetic condition," said Chief Executive Officer Reenie McCarthy.

Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Barth Syndrome

BOSTON, May 28, 2021 /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 Reenie McCarthy, CEO, will present at the virtual Jefferies Healthcare Conference on Tuesday, June 1, 2021 at 3:00 p.m. ET. A live audio webcast of the presentation will be available on the Investors & News section of Stealth's website at https://investor.stealthbt.com/.

Stealth BioTherapeutics to Present at Jefferies Virtual Healthcare Conference

Stealth BioTherapeutics Corp (MITO) CEO Reenie McCarthy on Q1 2021 Results - Earnings Call Transcript

The stock price of Stealth BioTherapeutics Corp (NASDAQ: MITO) increased by over 25% pre-market. This is why it happened.

Stealth BioTherapeutics (MITO): Over 25% Increase Pre-Market Explanation

BOSTON, May 18, 2021 /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 reported financial results for the quarter ended March 31, 2021 and announced recent business highlights. "Our team is energized by the potential of both elamipretide and our deep pipeline of novel mitochondrial-targeted compounds to address the devastating and typically progressive disease burden associated with diseases of mitochondrial dysfunction and we are thrilled to have secured additional financial resources to expand these development efforts," said Reenie McCarthy, Chief Executive Officer at Stealth.

Stealth BioTherapeutics Reports First Quarter 2021 Financial Results And Recent Business Highlights

Stealth BioTherapeutics Corp (NASDAQ: MITO) has reached an agreement with Morningside Ventures for Morningside to provide $30 million in additional payments to the Company during 2021 under its existing Development Funding Agreement. The payments will be paid in three tranches.

Stealth BioTherapeutics Stock Surges On $30M Funding To Advance Elamipretide Development

BOSTON, May 17, 2021 /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 it has reached agreement with Morningside Ventures for Morningside to provide $30 million of additional payments to the Company during 2021 under its existing Development Funding Agreement. The payments will be paid to the Company in three tranches.

Stealth BioTherapeutics Announces Additional Development Financing to Advance Elamipretide Clinical Trials

BOSTON, May 17, 2021 /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 presenting a poster at the 2021 American College of Cardiology (ACC) meeting being held virtually from May 15-17, 2021. The poster entitled "Elamipretide Improves Functional Assessments when Compared to the Natural History Progression of Cardiomyopathy-related Disease Symptomatology in Patients with Barth Syndrome: A TAZPOWER Analysis" presents data from a Phase 3 retrospective natural history control trial comparing the cardiac and functional effects of elamipretide on Barth syndrome patients at week 72 of the open label extension portion to a natural history control (NHC) cohort derived from a 9-year long NHC study and matched using propensity scoring.

Stealth BioTherapeutics Announces Poster Presentation at American College of Cardiology (ACC) Annual Meeting

BOSTON, May 13, 2021 /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 Reenie McCarthy, CEO, will present at the following upcoming virtual investor conferences in May: Oppenheimer's Rare & Orphan Disease Summit Date: Friday, May 21, 2021 Time: 9:55 – 10:35 a.m. ET UBS Global Healthcare Virtual Conference Date: Wednesday, May 26, 2021 Time: 10:00 – 10:45 a.m.

Stealth BioTherapeutics to Present at Upcoming Investor Conferences in May

BOSTON, May 11, 2021 /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 it will report first quarter 2021 financial results on Tuesday, May 18, 2021, before the market opens. Management will host a conference call at 8:30 am ET that day to discuss the financial results and provide a general business update.

Stealth BioTherapeutics to Report First Quarter Financial Results on Tuesday, May 18, 2021

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The stock price of Stealth BioTherapeutics Corp (NASDAQ: MITO) increased 77.5% (from $1.20 to $2.13) during pre-market trading. This is why it happened.

MITO Stock: 77.5% Increase (From $1.20 To $2.13 Increase) Pre-Market Explanation

BOSTON, May 5, 2021 /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 the presentation of new data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy (GA) and high risk drusen associated with dry age-related macular degeneration (AMD). The data, presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, showed that for patients with GA treated with elamipretide for 24-weeks, improvements from baseline in low light visual acuity (LLVA), which is the primary efficacy endpoint in Stealth's fully enrolled Phase 2 ReCLAIM-2 trial, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone (EZ).

Stealth BioTherapeutics Showcases Data for Elamipretide in Dry Age-Related Macular Degeneration at the 2021 ARVO Annual Meeting

BOSTON, April 28, 2021 /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 will have a poster presentation with a live discussion at the upcoming 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting which is being held May 1-7, 2021. The poster showcases data that are consistent with elamipretide's mechanism of action and provides further support for the company's design of ReCLAIM-2, Stealth's Phase 2 trial focused on earlier stages of geographic atrophy which recently completed enrollment.

News for Stealth BioTherapeutics Corp - ADR Stock (MITO)