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 the completion of enrollment for the RESPONSE study, a pivotal Phase 3 trial for seladelpar in patients with Primary Biliary Cholangitis (PBC). This global, placebo-controlled study aims to assess the safety and efficacy of seladelpar over 52 weeks, involving approximately 180 patients across 20 countries. The primary outcome is the responder rate at 52 weeks, focusing on patients inadequately controlled by ursodeoxycholic acid. Results are anticipated next year, aimed at enhancing treatment options for PBC patients.
CymaBay Therapeutics (NASDAQ: CBAY) announced promising findings regarding seladelpar's effect on patients with primary biliary cholangitis (PBC) presented at The International Liver Congress™ 2022. Data from a study showed a mean decrease in GLOBE score of -0.417 after two years of treatment, indicating improved transplant-free survival with a hazard ratio of 0.66. Seladelpar is recognized as a first-in-class therapy for PBC, highlighting its potential in enhancing patient outcomes. The company continues to advance its clinical studies and collaborations to provide benefits for PBC patients.
CymaBay Therapeutics (NASDAQ: CBAY) announced multiple presentations of its drug seladelpar at The International Liver Congress 2022 from June 22-26 in London. Key presentations include:
- A study on seladelpar's effect on improving the GLOBE score for transplant-free survival in PBC patients over two years.
- A preclinical comparison of seladelpar with other fibrosis-reducing agents.
- An oral presentation on how seladelpar suppresses bile acid synthesis via FGF-21 signaling.
Dr. Dennis Kim emphasized the significance of these findings for PBC patients.
CymaBay Therapeutics (NASDAQ: CBAY) presented new analyses of its drug seladelpar at Digestive Disease Week. Findings revealed that after 2 years of treatment for Primary Biliary Cholangitis (PBC), the GLOBE score significantly improved, suggesting enhanced transplant-free survival. A 384-patient pooled analysis showed seladelpar led to significant reductions in alkaline phosphatase (ALP) levels in compensated cirrhotic patients. Overall, seladelpar was reported as safe and well-tolerated, highlighting its potential in improving the quality of life for PBC patients.
CymaBay Therapeutics (NASDAQ: CBAY) provided updates on its clinical trials and financial performance for Q1 2022. The RESPONSE Phase 3 clinical trial of seladelpar for primary biliary cholangitis (PBC) is nearing completion of patient enrollment, with over 150 sites activated across 26 countries. The company reported a net loss of $27.8 million, or $0.32 per share, compared to a loss of $17.6 million, or $0.25 per share, in the prior year. As of March 31, 2022, CymaBay held $193 million in cash and equivalents, bolstered by a recent $25 million funding tranche from Abingworth.
CymaBay Therapeutics (NASDAQ: CBAY) announced that its seladelpar Phase 2 study was selected for the DDW Presidential Plenary Session, showcasing its potential in treating Primary Biliary Cholangitis (PBC). Scheduled for May 22, 2022, presentations will highlight the improvement of the GLOBE PBC Score and predict increased transplant-free survival. Additional presentations will discuss seladelpar's efficacy and safety in various patient groups, including those previously treated with Obeticholic Acid. CymaBay aims to provide innovative therapies for chronic liver diseases.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced a conference call to discuss its first-quarter financial results for 2022 on May 12, 2022, at 4:30 p.m. ET. The company is focused on developing therapies for liver diseases with significant unmet needs, notably through its lead candidate, seladelpar, which has received various designations from the FDA and EMA. Investors can access the call via phone or a live webcast at the company's investor relations website.
CymaBay Therapeutics (NASDAQ: CBAY) announced the publication of clinical results from its Phase 2 study of seladelpar for primary biliary cholangitis (PBC). The study showed dose-dependent reductions in alkaline phosphatase (ALP), with reductions of 26%, 33%, and 41% for 2 mg, 5 mg, and 10 mg doses at Week 8, maintaining efficacy at Week 52. Notably, 64% of patients on the 2 mg cohort achieved a composite biochemical response. Seladelpar also significantly reduced pruritus. The company is now enrolling a Phase 3 study to further evaluate seladelpar's efficacy and safety in PBC.
CymaBay Therapeutics (CBAY) appointed Dr. Éric Lefebvre to its Board of Directors, enhancing its leadership in liver disease therapies. Dr. Lefebvre brings over a decade of experience in pharmaceutical development, particularly in liver disease indications, which aligns with CymaBay's focus on its clinical candidate, seladelpar. The company aims to advance seladelpar toward regulatory approval and commercialization, especially for primary biliary cholangitis (PBC). CymaBay's breakthrough therapy and orphan drug designations underscore its commitment to addressing unmet medical needs.
CymaBay Therapeutics (CBAY) reported its financial results for Q4 and FY 2021, highlighting a net loss of $26.5 million for Q4 and $90 million for the year. The company has secured significant funding, including a $100 million risk-sharing agreement and a $75 million public equity offering, to support its Phase 3 clinical trials for the liver disease treatment seladelpar. With over 120 sites activated globally for the RESPONSE study, CymaBay is focused on improving outcomes for patients with primary biliary cholangitis (PBC). As of December 31, 2021, cash and investments totaled $194.6 million, expected to fund operations through 2023.
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