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 grant of a non-qualified stock option to Lewis Stuart, who has been appointed as Chief Commercial Officer. The award is for 360,000 shares, with an exercise price of $3.94 per share, matching the closing stock price on May 10, 2021. The stock option will vest 25% on May 10, 2022, with the remaining 75% vesting in monthly installments over three years, contingent on Mr. Stuart's employment. CymaBay focuses on developing therapies for liver diseases with unmet medical needs, including a breakthrough therapy for primary biliary cholangitis.
CymaBay Therapeutics (NASDAQ: CBAY) announced the appointment of Lewis Stuart as Chief Commercial Officer, effective May 10, 2021. With over 25 years in biopharma, Stuart's experience includes leadership roles at Myovant Sciences and Genomic Health. His expertise in launching therapies is expected to benefit CymaBay as it prepares for the anticipated launch of seladelpar, a treatment for primary biliary cholangitis (PBC). The company highlights its focus on patient care and innovative therapies, aiming to finalize regulatory submissions following the completion of its Phase 3 trial.
CymaBay Therapeutics (NASDAQ: CBAY) announced a conference call scheduled for May 13, 2021, to discuss its Q1 2021 financial results and provide a business update. The call will take place at 4:30 p.m. Eastern Time, and interested parties can join by calling 877-407-0784 (U.S.) or 201-689-8560 (international), with Conference ID #13718350. The live audio webcast will be accessible on the company's Investor Relations website.
CymaBay Therapeutics (NASDAQ: CBAY) has appointed Thomas Wiggans and Janet Dorling to its Board of Directors, enhancing its leadership team during pivotal development phases. Wiggans, a seasoned biopharma executive, brings extensive experience from companies like Dermira and Peplin, while Dorling, formerly the Chief Commercial Officer at CymaBay, has held senior roles at Gilead and Roche. Paul F. Truex resigned to focus on his new role as CEO of LQT Therapeutics. The appointments are expected to strengthen CymaBay's capabilities to advance its lead program, seladelpar, for treating primary biliary cholangitis (PBC).
CymaBay Therapeutics (NASDAQ: CBAY) has announced significant progress in its clinical development programs as of March 2021. They are actively recruiting patients for two global studies evaluating seladelpar in primary biliary cholangitis (PBC): the 52-week RESPONSE study and the ASSURE long-term safety study. The company also outlined plans for two additional programs, MBX-2982 and CB-0406, set for clinical trials in 2021. Financially, CymaBay reported a net loss of $15.8 million for Q4 2020, improved from $29.4 million in Q4 2019, and held $146.3 million in cash to fund operations into mid-2022.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) will host a conference call on March 25, 2021, at 4:30 PM ET to discuss its Q4 and full-year 2020 financial results, along with a business update. The company is focused on developing therapies for chronic liver diseases, particularly its candidate seladelpar for primary biliary cholangitis (PBC), which has received various designations from the FDA and EMA. CymaBay is commencing a global Phase 3 study for seladelpar, aiming to evaluate its safety and efficacy in treating PBC patients.
CymaBay Therapeutics (NASDAQ: CBAY) announced the presentation of two studies on seladelpar at the NASH-TAG Conference from March 11-13, 2021. The first, a poster presentation, highlights the assessment of NASH pathologies using machine learning from a Phase 2 trial. The second, an oral presentation, discusses the FDA hold and release of seladelpar. These presentations aim to stimulate further research into NASH, a disease affecting 20-40% of adults with detrimental liver effects. Seladelpar has received multiple designations from regulatory agencies.
CymaBay Therapeutics (NASDAQ: CBAY) announced its participation in three virtual investor conferences: Raymond James Annual Conference on March 1-3, H.C. Wainwright Global Life Sciences Conference on March 9-10, and Oppenheimer's Healthcare Conference on March 16-17, 2021. Management will discuss the development of seladelpar, a therapy for liver diseases, including primary biliary cholangitis. Seladelpar has received orphan designation and Breakthrough Therapy Designation from the FDA, highlighting its potential benefits in the treatment landscape.
CymaBay Therapeutics (NASDAQ: CBAY) announced participation in the SVB Leerink 10th Annual Global Healthcare Conference set for February 22-26, 2021. The company's management will present on February 25 at 12 PM Eastern Time in Track V.
CymaBay is advancing seladelpar, a therapy for primary biliary cholangitis (PBC), which has received FDA orphan designation and Breakthrough Therapy Designation. These designations highlight the high unmet medical need for treatments in chronic liver diseases.
CymaBay Therapeutics (NASDAQ: CBAY) announced positive results from the ENHANCE phase 3 study of seladelpar for primary biliary cholangitis (PBC). The study showed that 78.2% of patients on seladelpar 10 mg achieved the primary composite outcome at 3 months, compared to 12.5% on placebo. Seladelpar demonstrated significant anti-cholestatic, anti-inflammatory, and anti-pruritic effects, indicating it could be a viable second-line treatment. A global Phase 3 registration study, RESPONSE, is set to begin in Q1 2021 to further evaluate seladelpar's efficacy in PBC patients.
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