MITO

Stealth BioTherapeutics Corp. ADS
MITO

Delisted

MITO was delisted on the 15th of November, 2022.

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About: Stealth BioTherapeutics Corp is a clinical-stage biotechnology company. It is focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction.

Employees: 38

Healthcare Drug Manufacturers - General

Financial journalist opinion

Neutral
PRNewsWire
11 days ago
STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
NEEDHAM, Mass. , Aug. 18, 2025 /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 the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Barth syndrome.
STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
Neutral
Reuters
3 months ago
US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy
The U.S. Food and Drug Administration has asked for a resubmission of Stealth BioTherapeutics' marketing application for its experimental therapy targeting a rare genetic condition, Barth syndrome, the company said on Thursday.
US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy
Negative
Reuters
4 months ago
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment for a rare genetic condition that typically affects boys, the drug developer said on Tuesday.
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
Neutral
PRNewsWire
7 months ago
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
– New PDUFA Action Date of April 29, 2025, Allows FDA Additional Time to Complete Review –  – Follows Positive FDA Advisory Committee Meeting Vote Concluding that Elamipretide is Effective for the Treatment of Barth Syndrome – NEEDHAM, Mass. , Jan. 23, 2025 /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 the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for elamipretide, a first-in-class mitochondria-targeted therapeutic in development for individuals with Barth syndrome.
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
Neutral
PRNewsWire
1 year ago
STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION
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
Neutral
PRNewsWire
1 year ago
Stealth BioTherapeutics to Present at JMP Citizens Life Sciences Conference
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
Neutral
PRNewsWire
1 year ago
STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
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
Neutral
PRNewsWire
1 year ago
Stealth BioTherapeutics to Present at the Baird 2023 Biotech Discovery Series
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
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