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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.

News

CymaBay Therapeutics to Present at the 42nd Annual JP Morgan Healthcare Conference 2024

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announces President and CEO Sujal Shah's presentation at the 42nd Annual JP Morgan Healthcare Conference on January 10, 2024, focusing on innovative therapies for liver and chronic diseases.
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CymaBay Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) granted inducement awards to four employees on December 15, 2023. The Compensation Committee approved the grant of non-qualified stock options to purchase 176,000 shares of CymaBay common stock. The stock options have an exercise price of $22.03 per share and will vest over time based on the employees' continued employment.
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CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) submits NDA for seladelpar, a potential treatment for primary biliary cholangitis. The NDA is supported by data from over 500 patients, with Phase 3 trial results demonstrating significant improvement in markers of cholestasis and PBC-related pruritus. Seladelpar has been granted Breakthrough Therapy Designation by the FDA and is the only potent, selective, orally active delpar with promising results in clinical trials.
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CymaBay Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced the grant of inducement awards to five employees on November 15, 2023. The Compensation Committee approved the grant of non-qualified stock options to purchase 182,000 shares of CymaBay common stock. The options have an exercise price of $18.00 per share and will vest over time based on the employees' continued employment.
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CymaBay Announces an Oral Presentation of Seladelpar Phase 3 Pivotal Results in Primary Biliary Cholangitis at the Late Breaker Session of the Liver Meeting®

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced positive results from the RESPONSE Phase 3 study on seladelpar for patients with primary biliary cholangitis (PBC). The study showed significant improvement in the primary composite endpoint, alkaline phosphatase normalization, and reductions in patient-reported pruritus compared to placebo. These results support the submission of global market authorization applications.
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CymaBay Reports Third Quarter and Nine Months Ended September 30, 2023 Financial Results and Provides Corporate Update

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced top-line results from the Phase 3 study in PBC, achieving primary and secondary endpoints with Breakthrough Therapy Designation for seladelpar. The company also completed a public offering of common stock and pre-funded warrants with net proceeds of $242.8 million. The Phase 3b/4 study AFFIRM was initiated to evaluate the effect of seladelpar on clinical outcomes in patients with cirrhosis due to PBC.
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CymaBay Therapeutics to Present at Upcoming Investment Conferences

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CymaBay Therapeutics, Inc. (NASDAQ: CBAY) will be participating in three upcoming conferences: UBS Biopharma Conference on November 8-9th, Piper Sandler 35th Annual Healthcare Conference on November 28-30th, and Evercore ISI 6th Annual HealthCONx Conference on November 28-30th. The management team will engage in fireside chats and webcasts during these events.
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CymaBay Announces Publication of Two-year Safety and Efficacy Results of Seladelpar in Patients with Primary Biliary Cholangitis

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CymaBay Therapeutics announces two-year safety and efficacy results of seladelpar for primary biliary cholangitis (PBC). The study showed that 63% and 79% of patients achieved the composite endpoint after one and two years, respectively. ALP normalization was achieved in 23% and 42% of patients at one and two years, respectively. Sustained reductions in ALT and AST were observed. The long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury.
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CymaBay Therapeutics to Report Third Quarter of 2023 Financial Results on Tuesday, November 7, 2023

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CymaBay Therapeutics, Inc. will host a conference call and live webcast on November 7, 2023, to discuss financial results for Q3 2023 and provide a business update.
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CymaBay Presents Results on the Potential of Seladelpar in Treatment of Patients with Primary Biliary Cholangitis at ACG 2023

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CymaBay Therapeutics presented findings from its post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC). The analysis showed that baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31. Treatment with seladelpar was correlated with a significant decrease in both IL-31 levels and levels of patient-reported itch. Additionally, a post-hoc analysis of four seladelpar clinical trials found that PBC patients previously treated with ursodeoxycholic acid (UDCA) with elevated alkaline phosphatase (ALP) had a significant risk of disease progression.
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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.

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CymaBay Therapeutics, Inc.

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CBAY Stock Data

3.73B
96.64M
0.52%
103.13%
5.1%
Biotechnology
Healthcare
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United States
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