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), focused on therapies for chronic liver diseases, will participate in the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 9:00 am ET. This presentation marks a significant opportunity for CBAY to showcase its innovative pipeline, particularly its leading candidate, seladelpar, which has received breakthrough therapy designation for treating primary biliary cholangitis (PBC).
CymaBay is committed to addressing high unmet medical needs in liver health and chronic diseases. Its recent advancements have highlighted the potential of seladelpar in improving patient outcomes, supported by a rigorous understanding of liver disease mechanisms. For updates, visit their website at www.cymabay.com.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced significant corporate updates and financial results for the year and fourth quarter ended December 31, 2022. The company is advancing its Phase 3 study of seladelpar for patients with primary biliary cholangitis (PBC), having completed enrollment in July 2022. They expect to release top-line data in Q3 2023. Key financial highlights include a net loss of $106 million for 2022, up from $90 million in 2021, and cash reserves of $135.5 million, sufficient to fund operations through Q3 2024. The company also entered a licensing agreement with Kaken for seladelpar in Japan, receiving $34.2 million upfront.
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) will host a conference call on March 16, 2023, at 4:30 p.m. ET to discuss its financial results for Q4 and the year ending December 31, 2022. The call will provide a business update regarding the company’s clinical-stage biopharmaceutical developments centered on liver and chronic diseases. CymaBay has received several designations for its treatment, seladelpar, including breakthrough therapy and orphan drug status for primary biliary cholangitis. Interested parties can join the call using the provided numbers or access it via the company's website.
CymaBay Therapeutics announced its participation in the Oppenheimer 33rd Annual Healthcare Conference on March 13, 2023, at 11:20 AM Eastern Time, presenting in a fireside chat format. The company specializes in therapies for chronic liver diseases and holds significant designations such as breakthrough therapy and orphan drug status for its leading candidate, seladelpar, aimed at treating primary biliary cholangitis (PBC). CymaBay is committed to addressing high unmet medical needs with innovative therapies. For more details, visit cymabay.com.
CymaBay Therapeutics (NASDAQ: CBAY) announced its participation in the SVB Securities Global Biopharma Conference on February 15, 2023, at 3:40 PM Eastern Time. The event will be conducted in a virtual format and will feature a fireside chat. CymaBay specializes in developing therapies for liver diseases with high unmet needs, focusing on their lead candidate, seladelpar, for treating primary biliary cholangitis (PBC). The company has received several designations from health authorities, indicating its commitment to addressing significant medical challenges.
For more details, visit www.cymabay.com.
CymaBay Therapeutics (Nasdaq: CBAY) has successfully closed its public offering of 11,821,428 shares of common stock at $7.00 per share, including additional shares from underwriters' options. Additionally, the company offered pre-funded warrants for 2,142,857 shares at $6.9999 each. The offering, priced before discounts, was completed on January 26, 2023. Proceeds will fund the ongoing development of seladelpar, including clinical trials for market expansion, alongside general corporate purposes. The offering was facilitated by Piper Sandler, Raymond James, and Cantor Fitzgerald.
CymaBay Therapeutics (Nasdaq: CBAY) announced the pricing of a public offering, selling 10 million shares of common stock at $7.00 each, and pre-funded warrants for 2,142,857 shares at $6.9999. The gross proceeds are expected to be about $85 million, before expenses. The funds will support ongoing development of seladelpar and general corporate purposes. The offering is expected to close on January 26, 2023, subject to customary conditions. Piper Sandler, Raymond James, and Cantor are acting as joint book-running managers. The offering is registered with the SEC under a shelf registration statement.
CymaBay Therapeutics (Nasdaq: CBAY) has announced an underwritten public offering of common stock and pre-funded warrants, with a potential 15% additional option for underwriters. The offering is contingent on market conditions, and the company aims to use net proceeds for the development of seladelpar and general corporate purposes. Joint book-running managers for the offering include Piper Sandler, Raymond James, and Cantor Fitzgerald. CymaBay warns that actual results may vary due to market risks and uncertainties surrounding the offering.
CymaBay Therapeutics announced a collaboration with Kaken Pharmaceutical for the development of seladelpar in Japan to treat primary biliary cholangitis (PBC). The deal includes an upfront payment of approximately $34 million and potential milestone payments up to $128.4 million. This partnership addresses a critical need in Japan, as there are currently no approved second-line treatments for PBC. CymaBay aims to enhance access to innovative therapies for patients both in Japan and globally.
CymaBay Therapeutics reported Q3 2022 financial results, revealing a net loss of $24.5 million or ($0.28) per share, compared to a loss of $22.7 million or ($0.33) per share in Q3 2021. The company completed enrollment in its RESPONSE study for seladelpar, with 193 patients enrolled. Cash reserves stand at $153.4 million, sufficient to fund operations through 2023. R&D expenses decreased to $15.5 million from $17.0 million year-over-year. Additionally, preparations for NDA submission and launch of seladelpar are progressing. Top-line data from RESPONSE is expected in Q3 2023.
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