Key Details
Annual ROE
115.97%Beta
-Events Calendar
Next earnings date:
N/ARecent quarterly earnings:
June 30, 2023Recent annual earnings:
Apr 06, 2021Next ex-dividend date:
N/ARecent ex-dividend date:
N/ANext split:
N/ARecent split:
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Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
MITO
prnewswire.com23 January 2025
– 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.
FAQ
- What is the primary business of Stealth BioTherapeutics?
- What is the ticker symbol for Stealth BioTherapeutics?
- Does Stealth BioTherapeutics pay dividends?
- What sector is Stealth BioTherapeutics in?
- What industry is Stealth BioTherapeutics in?
- What country is Stealth BioTherapeutics based in?
- When did Stealth BioTherapeutics go public?
- Is Stealth BioTherapeutics in the S&P 500?
- Is Stealth BioTherapeutics in the NASDAQ 100?
- Is Stealth BioTherapeutics in the Dow Jones?
- When was Stealth BioTherapeutics's last earnings report?
- When does Stealth BioTherapeutics report earnings?
What is the primary business of Stealth BioTherapeutics?
Stealth BioTherapeutics Corp, a clinical-stage biotechnology company, focuses on the discovery, development, and commercialization of therapies for diseases involving mitochondrial dysfunction. Its lead product candidate is Elamipretide that is in phase 3 clinical trial to treat barth syndrome, phase 2/3 clinical trial for the treatment of duchenne cardiomyopathy, phase 2a clinical trial to treat friedreich's ataxia, phase 2 clinical trial for the treatment of dry age-related macular degeneration, phase 2 clinical trial to treat leber's hereditary optic neuropathy, and phase 3 clinical trial for the treatment of replisome myopathies. The company's product candidates also include SBT-20 to treat complications of diabetes, renal diseases, ocular diseases, neurodegenerative, Parkinson's, Alzheimer's, Huntington's, and ALS diseases; SBT-550 for rare neurological indications; and SBT-272, a peptidomimetic that targets the mitochondria and stabilizing mitochondrial function under conditions of oxidative stress, as well as SBT 550. Stealth BioTherapeutics Corp was incorporated in 2006 and is based in George Town, the Cayman Islands.
What is the ticker symbol for Stealth BioTherapeutics?
The ticker symbol for Stealth BioTherapeutics is NASDAQ:MITO
Does Stealth BioTherapeutics pay dividends?
No, Stealth BioTherapeutics does not pay dividends
What sector is Stealth BioTherapeutics in?
Stealth BioTherapeutics is in the Healthcare sector
What industry is Stealth BioTherapeutics in?
Stealth BioTherapeutics is in the Biotechnology industry
What country is Stealth BioTherapeutics based in?
Stealth BioTherapeutics is headquartered in Cayman Islands
When did Stealth BioTherapeutics go public?
Stealth BioTherapeutics's initial public offering (IPO) was on 15 February 2019
Is Stealth BioTherapeutics in the S&P 500?
No, Stealth BioTherapeutics is not included in the S&P 500 index
Is Stealth BioTherapeutics in the NASDAQ 100?
No, Stealth BioTherapeutics is not included in the NASDAQ 100 index
Is Stealth BioTherapeutics in the Dow Jones?
No, Stealth BioTherapeutics is not included in the Dow Jones index
When was Stealth BioTherapeutics's last earnings report?
Stealth BioTherapeutics's most recent earnings report was on 30 June 2023
When does Stealth BioTherapeutics report earnings?
The date for Stealth BioTherapeutics's next earnings report has not been announced yet