Profile
Sector:
HealthcareIndustry:
BiotechnologyCountry:
United StatesIPO:
07 November 2019Website:
http://www.galeratx.comNext earnings report:
14 August 2024Last dividends:
N/ANext dividends:
N/APrice
regular market | 23 min agoDividend
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We look at a few biotech companies, LEGN, KOD, GRTX, which are poised to beat second-quarter earnings estimates.
Galera Therapeutics shares plunged by almost 85% after the clinical-stage biopharmaceutical company revealed its New Drug Application for its investigational therapeutic avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment was not approved by the Food and Drug Administration (FDA). The company said that the FDA had informed it that the data from its Phase 3 ROMAN trial and supporting data from its GT-201 trial were “not sufficiently persuasive to establish substantial evidence of avasopasem's effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.
Galera Therapeutics (NASDAQ: GRTX ) stock is falling hard on Thursday following a drug rejection by the FDA! In a Complete Response Letter ( CRL ), the FDA rejected the company's New Drug Application (NDA) for avasopasem manganese.
Galera Therapeutics Inc said the U.S. health regulator declined to approve its drug to treat radiotherapy-induced severe mouth inflammation in patients with advanced head and neck cancer undergoing standard-of-care treatment.
Galera Therapeutics: A Possible Solution To Severe Oral Mucositis In Head And Neck Cancer Patients.
What type of business is Galera Therapeutics?
Galera Therapeutics, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics for the transformation of radiotherapy in cancer. The company's lead product candidate is avasopasem manganese (GC4419), a small molecule superoxide dismutase mimetic, which has completed Phase III clinical trial for the treatment of radiotherapy induced severe oral mucositis in patients with head and neck cancer (HNC); in Phase IIa clinical trial for the treatment of radiotherapy-induced esophagitis in patients with lung cancer; and in Phase IIa clinical trial for patients with HNC undergoing standard-of-care radiotherapy. It is also involved in developing GC4711, a superoxide dismutase mimetic product candidate, which is in Phase I/II clinical trial in combination with stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer and locally advanced pancreatic cancer. The company was incorporated in 2012 and is headquartered in Malvern, Pennsylvania.
What sector is Galera Therapeutics in?
Galera Therapeutics is in the Healthcare sector
What industry is Galera Therapeutics in?
Galera Therapeutics is in the Biotechnology industry
What country is Galera Therapeutics from?
Galera Therapeutics is headquartered in United States
When did Galera Therapeutics go public?
Galera Therapeutics initial public offering (IPO) was on 07 November 2019
What is Galera Therapeutics website?
https://www.galeratx.com
Is Galera Therapeutics in the S&P 500?
No, Galera Therapeutics is not included in the S&P 500 index
Is Galera Therapeutics in the NASDAQ 100?
No, Galera Therapeutics is not included in the NASDAQ 100 index
Is Galera Therapeutics in the Dow Jones?
No, Galera Therapeutics is not included in the Dow Jones index
When does Galera Therapeutics report earnings?
The next expected earnings date for Galera Therapeutics is 14 August 2024