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CymaBay Therapeutics, Inc. - CBAY STOCK NEWS

Welcome to our dedicated page for CymaBay Therapeutics news (Ticker: CBAY), a resource for investors and traders seeking the latest updates and insights on CymaBay Therapeutics stock.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) is a clinical-stage biopharmaceutical company based in the San Francisco Bay Area, dedicated to developing therapies that address high unmet medical needs in metabolic diseases as well as rare and orphan diseases. The company has been pivotal in creating breakthrough medicines aimed at improving the lives of patients and their families. Seeded with assets from a previous metabolic disease company, CymaBay boasts a robust pipeline thanks to an investment of over $120 million.

CymaBay’s flagship investigational treatment, seladelpar, is designed to manage primary biliary cholangitis (PBC), a chronic liver disease that predominantly affects women. Seladelpar, which has been granted Breakthrough Therapy Designation by the FDA, has demonstrated significant improvements in Phase 3 trials for markers of cholestasis and PBC-related pruritus. Recent developments saw CymaBay submitting a New Drug Application (NDA) for seladelpar to the FDA, requesting Priority Review. If accepted, the FDA aims to complete the review within six months.

In addition to its U.S. application, CymaBay plans to file marketing authorization applications with the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in the first half of 2024. Seladelpar has already received Priority Medicines (PRIME) status from the EMA.

The company's recent achievements were highlighted by the publication of Phase 3 trial results in The New England Journal of Medicine, showcasing seladelpar’s rapid and sustained improvements in reducing liver injury and pruritus. Financially, CymaBay ended 2023 with $416.2 million in cash, cash equivalents, and investments. Additionally, the pending acquisition of CymaBay by Gilead underscores the potential impact of seladelpar and other pipeline therapies.

The scientific and clinical expertise at CymaBay, coupled with their strategic focus on liver inflammation and fibrosis, positions them at the forefront of therapeutic innovation. Their evidence-based approach and commitment to high-quality standards reflect their dedication to improving patient outcomes and quality of life.

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CymaBay Therapeutics announces FDA's revised Breakthrough Therapy Designation for seladelpar in the treatment of primary biliary cholangitis (PBC)
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CymaBay Therapeutics announces late-breaking presentation on results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) at The Liver Meeting®
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CymaBay Therapeutics grants inducement awards to two employees
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CymaBay Therapeutics initiates AFFIRM study to evaluate seladelpar's effect on clinical outcomes in patients with PBC. Study aims to confirm benefit of seladelpar over a 3-year period.
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CymaBay to participate in Cantor Global Healthcare Conference on September 27th
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CymaBay Therapeutics closes underwritten public offering, raising approximately $258.7 million. Proceeds to be used for seladelpar development and general corporate purposes.
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CymaBay Therapeutics announces pricing of public offering of common stock and pre-funded warrants.
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CymaBay Therapeutics announces underwritten public offering of $150 million of common stock and pre-funded warrants
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CymaBay announces positive Phase 3 results for seladelpar in PBC, meeting primary and key secondary endpoints. 61.7% of patients on seladelpar achieved primary composite endpoint vs. 20.0% on placebo. Normalization of alkaline phosphatase at 12 months achieved by 25.0% on seladelpar vs. 0% on placebo. Reduction in pruritus observed with seladelpar treatment. Safety and tolerability comparable between groups. Advancement to regulatory discussions and filing for approval planned.
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CymaBay Therapeutics to announce topline results from Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) in investor call
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FAQ

What is the market cap of CymaBay Therapeutics (CBAY)?

The market cap of CymaBay Therapeutics (CBAY) is approximately 3.7B.

What is CymaBay Therapeutics, Inc.?

CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing therapies for metabolic diseases and rare and orphan diseases.

Where is CymaBay Therapeutics located?

CymaBay Therapeutics is located in the San Francisco Bay Area.

What is seladelpar?

Seladelpar is CymaBay’s investigational treatment for primary biliary cholangitis (PBC), an inflammatory liver disease.

What recent milestone did seladelpar achieve?

CymaBay recently submitted an NDA for seladelpar to the FDA, which was granted priority review.

What designations has seladelpar received?

Seladelpar has received Breakthrough Therapy Designation from the FDA and Priority Medicines (PRIME) status from the EMA.

What financial position did CymaBay report at the end of 2023?

CymaBay reported having $416.2 million in cash, cash equivalents, and investments as of December 31, 2023.

What is the focus of CymaBay’s research and development?

CymaBay focuses on therapies for liver inflammation, fibrosis, and chronic diseases with high unmet medical needs.

What are the main symptoms of primary biliary cholangitis (PBC)?

The main symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients.

What is the significance of the Phase 3 trial results for seladelpar?

Phase 3 trial results showed that seladelpar significantly improved markers of cholestasis and pruritus in PBC patients.

Who should be contacted for more information about CymaBay Therapeutics?

For more information, you can contact Theresa Dolge at Evoke Kyne or PJ Kelleher at LifeSci Advisors.

CymaBay Therapeutics, Inc.

Nasdaq:CBAY

CBAY Rankings

CBAY Stock Data

3.73B
110.08M
0.52%
103.13%
5.1%
Biotechnology
Healthcare
Link
United States
Fremont