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 (NASDAQ: CBAY) announced participation in three virtual investor conferences: Citi’s 16th Annual BioPharma Virtual Conference from September 8-10, 2021, H.C. Wainwright 23rd Annual Global Investment Conference on September 13-15, 2021, and 2021 Cantor Virtual Global Healthcare Conference from September 27-30, 2021.
The H.C. Wainwright conference features a fireside chat on September 13 at 7:00 am ET, and the Cantor conference includes a fireside chat on September 28 at 3:20 pm ET, both available via webcast.
CymaBay Therapeutics has secured up to $100 million in non-dilutive funding from Abingworth Funds for the Phase 3 development of seladelpar in treating primary biliary cholangitis (PBC), which includes the ongoing RESPONSE and ASSURE clinical trials. Enrollment activities are progressing, with RESPONSE targeting 180 patients. Financial results indicate a net loss of $23.2 million for the second quarter of 2021. CymaBay's cash reserves are sufficient to fund operations through 2023, despite challenges posed by the pandemic.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced a conference call on August 12, 2021, at 4:30 p.m. ET to discuss its Q2 2021 financial results and provide a business update. The company focuses on therapies for liver and chronic diseases with high unmet needs, notably its first-in-class treatment seladelpar, which has received breakthrough therapy and orphan drug status. Investors can access the call by dialing 877-407-0784 (U.S.) or 201-689-8560 (internationally), and the webcast will be available on the company’s website.
CymaBay Therapeutics announced a $100 million non-dilutive financing agreement with Abingworth to fund the Phase 3 development of seladelpar for primary biliary cholangitis (PBC). This deal allows CymaBay to retain full global commercial rights. The funding will be received in installments, with options for additional funds after trial enrollment. CEO Sujal Shah emphasized the strategic nature of the agreement, which aims to support seladelpar's potential as a second-line PBC treatment. CymaBay is currently progressing in its Phase 3 RESPONSE trial.
CymaBay Therapeutics (CBAY) announced promising data from its Phase 2 and ENHANCE Phase 3 studies of seladelpar for primary biliary cholangitis (PBC). Results showed 50% of patients on 5 mg and 63% on 10 mg dosages met the composite endpoint after 3 months, compared to none in the placebo group. Seladelpar also demonstrated safety and tolerability in patients with compensated cirrhosis. The ongoing RESPONSE Phase 3 study aims to further validate these findings. Additionally, the FDA lifted the clinical hold on seladelpar, advancing its potential treatment options for PBC.
CymaBay Therapeutics (NASDAQ: CBAY) announced participation in three upcoming virtual investor conferences, aimed at addressing chronic liver diseases. The events include the SVB Leerink CybeRx Series "Liver Disease Day" on June 17, the Raymond James Human Health Innovation Conference on June 21, and the Piper Sandler "EASL Takeaway Day" on June 28. The company has received breakthrough therapy designation for its treatment, seladelpar, targeting primary biliary cholangitis.
CymaBay Therapeutics (NASDAQ: CBAY) announced multiple presentations for seladelpar at The International Liver Congress™ 2021, scheduled from June 23-26, 2021. Key topics include the efficacy and safety of seladelpar for patients with compensated liver cirrhosis due to primary biliary cholangitis (PBC) and its use in PBC patients previously treated with obeticholic acid. Additionally, presentations will cover drug-induced liver injury in NASH patients and effects of a combination therapy in an obese mouse model of NASH. The ongoing RESPONSE Phase 3 study in PBC is also highlighted.
CymaBay Therapeutics (NASDAQ: CBAY) announced the appointment of Dr. Dennis Kim as Chief Medical Officer with a stock option grant of 390,000 shares at an exercise price of $4.37. This grant is compliant with Nasdaq regulations and will vest over four years, starting with 25% in one year, followed by 36 equal monthly installments. CymaBay is focused on developing therapies for liver diseases and has received various designations for its lead product, seladelpar, aimed at addressing primary biliary cholangitis (PBC).
CymaBay Therapeutics (NASDAQ: CBAY) announced leadership changes and ongoing clinical trials in its latest press release. Dr. Dennis Kim joins as Chief Medical Officer, while Lewis Stuart becomes Chief Commercial Officer. The company is actively recruiting patients for two global studies on seladelpar aimed at treating primary biliary cholangitis (PBC), namely RESPONSE and ASSURE. Financially, CymaBay reported a net loss of $17.6 million for Q1 2021, with increasing R&D expenses driven by clinical trial activities. The company holds $125.5 million in cash, sufficient to fund operations into mid-2022.
CymaBay Therapeutics (NASDAQ: CBAY) has appointed Dr. Dennis D. Kim as Chief Medical Officer to lead clinical functions as the company advances its Phase 3 trials for seladelpar, a treatment for primary biliary cholangitis (PBC). Dr. Kim brings over 20 years of drug development experience, previously holding leadership roles at various biotech firms. His joining underscores CymaBay’s commitment to enhance patient lives through innovative liver disease therapies. The appointment is strategic as CymaBay focuses on addressing significant unmet medical needs in chronic liver conditions.
FAQ
What is the market cap of CymaBay Therapeutics (CBAY)?
What is CymaBay Therapeutics, Inc.?
Where is CymaBay Therapeutics located?
What is seladelpar?
What recent milestone did seladelpar achieve?
What designations has seladelpar received?
What financial position did CymaBay report at the end of 2023?
What is the focus of CymaBay’s research and development?
What are the main symptoms of primary biliary cholangitis (PBC)?
What is the significance of the Phase 3 trial results for seladelpar?
Who should be contacted for more information about CymaBay Therapeutics?
