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.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced a conference call and live audio webcast scheduled for November 14, 2022, at 4:30 p.m. Eastern Time. The call will discuss the company's financial results for Q3 2022, which ended on September 30, 2022, along with a business update. CymaBay focuses on developing therapies for liver and chronic diseases, with seladelpar designated as a breakthrough therapy and orphan drug for primary biliary cholangitis. More information is available on their website.
CymaBay Therapeutics, Inc. (CBAY) presented promising data on seladelpar for primary biliary cholangitis (PBC) at The Liver Meeting 2022 in Washington, DC. Results from Phase 2 and 3 studies showcased significant improvements in lipid profiles, specifically in total cholesterol and triglycerides, for patients resistant to ursodiol. Additionally, seladelpar demonstrated beneficial changes in serum metabolomics, enhancing fatty acid oxidation and reducing inflammatory mediators. With the RESPONSE study fully enrolled, CymaBay anticipates sharing pivotal results in 2023.
CymaBay Therapeutics (NASDAQ: CBAY) announced its participation in two upcoming healthcare conferences: the Credit Suisse 31st Healthcare Conference on November 8, 2022, and the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022. At both events, management will engage in fireside chats to discuss the company’s innovative therapies for liver diseases, particularly focusing on seladelpar, a treatment for primary biliary cholangitis (PBC). Webcasts for both presentations will be available through CymaBay's investor relations page.
CymaBay Therapeutics (NASDAQ: CBAY) has appointed Dr. Charles McWherter as President of Research and Development, in addition to his role as Chief Scientific Officer. With CymaBay since 2007, Dr. McWherter has driven the development of seladelpar, a therapy for primary biliary cholangitis. His extensive experience in drug development is expected to enhance the company’s pipeline and lead to successful commercialization. The appointment is viewed positively as it brings continuity and deep industry expertise to CymaBay's R&D efforts.
CymaBay Therapeutics (NASDAQ: CBAY) announced the presentation of three abstracts pertaining to its seladelpar program for treating primary biliary cholangitis (PBC) at The Liver Meeting® from November 4-8, 2022.
Key findings include significant lipid profile improvements in PBC patients and insights into the drug's anti-inflammatory mechanisms. The presentations will be delivered by experts, highlighting seladelpar's potential to enhance patient outcomes.
CymaBay aims to address unmet needs in chronic liver diseases through its innovative therapies.
CymaBay Therapeutics (NASDAQ: CBAY) announced a virtual analyst day on September 22, 2022, focusing on seladelpar, its leading asset for treating primary biliary cholangitis (PBC). The event will feature insights from hepatology expert Kris Kowdley, alongside presentations from CymaBay's leadership about the clinical development progress of seladelpar. PBC is a chronic liver disease primarily affecting women, characterized by impaired bile flow and potential serious health risks. Seladelpar, a first-in-class oral PPARδ agonist, aims to address unmet medical needs in PBC treatment.
CymaBay Therapeutics, a clinical-stage biopharmaceutical company focused on liver diseases, will participate in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The management will host a Fireside Chat on September 14 at 11:30am ET. CymaBay is known for its innovative therapies addressing chronic liver diseases, notably seladelpar, a treatment for primary biliary cholangitis (PBC), which has received breakthrough therapy designation. For more information, visit cymabay.com.
CymaBay Therapeutics (NASDAQ: CBAY) announced participation in a symposium on primary biliary cholangitis (PBC) hosted by B. Riley Securities on August 24, 2022. The event features discussions on first- and second-line therapies for PBC, alongside insights into the mid- to late-stage therapeutics pipeline. The symposium will include a PBC expert panel and a fireside chat with CymaBay, focusing on improving patient outcomes and quality of life. CymaBay's seladelpar has received breakthrough therapy designation for PBC.
CymaBay Therapeutics (NASDAQ: CBAY) announced the completion of enrollment in its Phase 3 RESPONSE study, achieving 193 patients across 20 countries for seladelpar in primary biliary cholangitis (PBC). Topline data is expected in Q3 2023. The company reported a net loss of $27.1 million for Q2 2022, a slight increase from $23.2 million in Q2 2021. As of June 30, 2022, CymaBay held $170.8 million in cash and equivalents, sufficient to fund operations through 2023. The firm aims to enhance its development programs while managing expenses effectively.
CymaBay Therapeutics (NASDAQ: CBAY) has announced a conference call scheduled for August 11, 2022, at 4:30 p.m. ET, to discuss its Q2 2022 financial results and provide a business update. The company focuses on therapies for liver diseases and has received breakthrough therapy designation and orphan drug status for its treatment, seladelpar, targeting primary biliary cholangitis (PBC). Investors can access the call by dialing the provided numbers or through the company's website's Investor section.
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