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 a conference call on March 17, 2022, at 4:30 PM ET to discuss its financial results for Q4 and the full year ending December 31, 2021. The company, focused on therapies for liver diseases, has achieved breakthrough therapy designation for its first-in-class drug, seladelpar, aimed at treating primary biliary cholangitis (PBC). The audio of the call will be accessible through their investor relations website.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced its participation in two virtual investor conferences: the 11th Annual SVB Leerink Global Healthcare Conference from February 14-18, 2022, and Oppenheimer’s 32nd Annual Healthcare Conference on March 15-16, 2022. Management will present on February 17 at 3:00 PM ET and March 16 at 4:40 PM ET, respectively. CymaBay is focused on therapies for liver diseases, notably seladelpar for primary biliary cholangitis, which has received breakthrough and orphan drug designations from regulatory agencies.
CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced the pricing of its public offering, selling 15,625,000 shares of common stock at $4.00 each and pre-funded warrants at $3.9999 each for a gross total of approximately $75 million. Proceeds will be used for the development of seladelpar and general corporate purposes. The offering is set to close on November 22, 2021, pending customary closing conditions. Piper Sandler, Raymond James, and Cantor are managing the offering, with a 30-day option for underwriters to purchase an additional 2,812,500 shares.
CymaBay Therapeutics (CBAY) announced a public offering of common stock and pre-funded warrants on November 17, 2021. The offering, subject to market conditions, includes a 30-day option for underwriters to purchase an additional 15% of shares. Proceeds from the offering are intended for the development of seladelpar and for general corporate purposes. Piper Sandler and Raymond James are managing the offering. The securities will be offered under a shelf registration statement effective since July 2020.
CymaBay Therapeutics (NASDAQ: CBAY) presented positive long-term efficacy and safety data for seladelpar at The Liver Meeting 2021. Over two years, seladelpar treatment led to a significant decrease of 50% in alkaline phosphatase (ALP) levels, with 79% of patients achieving a composite clinical response. The treatment was well-tolerated, with no liver-related serious adverse events reported. Seladelpar was also effective in patients with compensated cirrhosis and portal hypertension, showcasing its potential as a viable long-term option for patients suffering from primary biliary cholangitis (PBC).
CymaBay Therapeutics (NASDAQ: CBAY) announced a KOL webinar on seladelpar for primary biliary cholangitis (PBC) on November 15, 2021, at 4:30 PM EST. The webinar features presentations by Dr. Marlyn J. Mayo and Dr. Cynthia Levy discussing clinical data on seladelpar's efficacy and safety in treating PBC. The RESPONSE Phase 3 study highlights its potential benefits, showing significant reductions in alkaline phosphatase levels in cirrhotic patients. The event aims to inform on the development of seladelpar, a promising treatment for PBC.
CymaBay Therapeutics (NASDAQ: CBAY) announced significant updates in its Phase 3 RESPONSE study for seladelpar in patients with primary biliary cholangitis (PBC), now with over 100 activated clinical sites worldwide. The company reported financial results for Q3 2021, showing a net loss of $22.7 million. They secured a non-dilutive financing agreement with Abingworth for up to $100 million, aiding PBC development. Upcoming presentations at The Liver Meeting® will showcase promising efficacy data from prior studies. CymaBay is well-positioned for future growth despite the challenges posed by the pandemic.
CymaBay Therapeutics (NASDAQ: CBAY) has announced its participation in three virtual investor conferences scheduled for November and December 2021. The Credit Suisse 30th Annual Healthcare Conference will feature a fireside chat on November 8 at 11:20 am ET. The Evercore ISI 4th Annual HealthCONx Conference will include a session on November 30 at 9:15 am ET. Lastly, the Piper Sandler 33rd Annual Virtual Healthcare Conference will take place on December 2 at 10:00 am ET. For more information, visit CymaBay's Investor Events page.
CymaBay Therapeutics (NASDAQ: CBAY) will host a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its Q3 financial results and provide a business update. The company is focused on developing therapies for high unmet medical needs in liver and chronic diseases. CymaBay has received breakthrough therapy designation, PRIority MEdicines status, and orphan drug status for its treatment, seladelpar, targeting primary biliary cholangitis (PBC).
CymaBay Therapeutics (NASDAQ: CBAY) announced that its drug seladelpar will be presented at The Liver Meeting Digital Experience™ 2021 from November 12-15. Key presentations include data on the long-term safety and efficacy of seladelpar in patients with Primary Biliary Cholangitis (PBC), showing a 50% reduction in alkaline phosphatase levels after two years. Another presentation focuses on PBC patients with compensated cirrhosis, showing a 45% reduction in alkaline phosphatase after three months. Seladelpar demonstrates strong potential as a treatment for liver diseases.
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