CymaBay Therapeutics

CymaBay Therapeutics, Inc. engages in the provision and development of access to therapies for patients with liver and other chronic diseases with high unmet medical needs. Its products pipeline includes Seladelpar, MBX-2982, CB-0406, and CB-001. The company was founded on October 5, 1988 and is headquartered in Newark, CA.

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CymaBay Therapeutics progresses in Phase 3 program, eyes commercial readiness

CymaBay Therapeutics is well-positioned with strong financials, a robust team, and a comprehensive approach to product launch and market access.
While facing challenges in regulatory engagement and competitive landscape, the company's focus on research, patient preferences, and global expansion provides opportunities for growth.
Anticipation for top-line data in Q3 2023 and a busy year ahead signal exciting prospects for CymaBay as they navigate towards potential commercial transformation.
Overall, CymaBay's strategic advancements, partnerships, and focus on patient outcomes position them favorably in the competitive landscape of PBC treatments.

CymaBay Therapeutics reports strong Phase 3 progress and financial stability

CymaBay Therapeutics showcased positive Phase 3 progress for seladelpar, backed by a strong financial position and a patient-centric approach to treatment advancement.
The company faces challenges in competitive positioning, resource allocation for post-marketing commitments, and meeting regulatory and patient expectations.
Opportunities lie in market expansion through partnerships, differentiation through clinical data, and enhancing treatment outcomes through ongoing studies.
Overall, CymaBay Therapeutics is poised for growth with a focus on advancing treatment guidelines, leveraging real-world data, and addressing unmet medical needs.

CymaBay reports strong Q2 earnings, faces reimbursement challenges ahead

CymaBay's Q2 2023 performance reflects financial strength and progress in seladelpar development, with upcoming milestone results expected.
While seladelpar shows promise in improving PBC patient quality of life, challenges in reimbursement criteria and rising expenses persist.
Opportunities lie in expanding patient reach through IDEAL study, exploring combination therapies, and transitioning patients into commercial use.

CymaBay excels in Q3 with seladelpar breakthrough therapy designation

CymaBay's Q3 2023 was marked by success in pivotal trials and financial strength, positioning seladelpar as a promising PBC treatment.
While facing challenges in expenses and regulatory concerns, CymaBay is leveraging opportunities in market expansion and differentiation.
The company's commitment to generating data and strategic pre-commercialization efforts underpin its confidence in seladelpar's potential.

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CymaBay Therapeutics is a clinical-stage biopharmaceutical company located in the San Francisco Bay Area focused on the development and commercialization of proprietary new medicines for important human diseases. We are committed to developing breakthrough medicines that improve the lives of patients and their families. CymaBay was seeded with the assets from an earlier metabolic disease company in which more than $120M was invested to produce a robust pipeline.  Arhalofenate is a novel oral small molecule being developed to treat the approximately 1 million gout patients that flare three or more times per year. Gout flares are painful inflammatory episodes caused by crystals of monosodium urate (MSU) that result from excess serum uric acid (sUA). In three Phase 2 studies in gout patients arhalofenate was shown to reduce the incidence and duration of flares while simultaneously lowering sUA. If confirmed in additional clinical studies, arhalofenate’s dual acting profile would be unique since all other urate lowering therapies paradoxically increase flares as they lower sUA over the first 6 to 12 months of treatment. Increased flares lead many patients to stop or avoid treatment leading to progression of disease with pain and suffering, erosion of joint structure and functionality, lost time from work, and increased healthcare costs.

Gilead Sciences

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value. The addition of CymaBay's investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead's existing liver portfolio and aligns with its long-standing commitment to.

Gilead Sciences Announces Completion of Acquisition of CymaBay

MAA Validation Follows Recent Applications for Seladelpar to the U.K. MHRA and U.S. FDA MAA Validation Follows Recent Applications for Seladelpar to the U.K. MHRA and U.S. FDA

CymaBay Announces European Medicines Agency Accepts for Review the Marketing Authorization Application for Seladelpar for the Treatment of Primary Biliary Cholangitis

CymaBay Therapeutics Inc. (CBAY) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.32. This compares to loss of $0.30 per share a year ago.

CymaBay Therapeutics Inc. (CBAY) Reports Q4 Loss, Misses Revenue Estimates

Gilead Sciences, Inc. has proposed to acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.

CymaBay Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Corporate Update

-  Seladelpar demonstrated normalization of liver biomarkers and significant reductions across three measures of patient-reported itch vs. placebo -  NEWARK, Calif.

The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay's Seladelpar in Primary Biliary Cholangitis

NEWARK, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced the grant of inducement awards to three employees on February 16, 2024 (the “Grant Date”) in connection with the employees' commencement of employment at CymaBay. The Compensation Committee of the Board of Directors of CymBay approved the grant of non-qualified stock options to purchase an aggregate of 99,000 shares of CymaBay common stock as inducements material to the employees entering into employment with CymaBay in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grants.

CymaBay Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of CymaBay Therapeutics, Inc. (NasdaqGS: CBAY) to Gilead Sciences, Inc. (NasdaqGS: GILD). Under the terms of the proposed transaction, shareholders of CymaBay will receive $32.50 in cash for each share of CymaBay that they own. KSF is seeking to determine whether this consideration and the process that led to it.

CYMABAY THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of CymaBay Therapeutics, Inc. - CBAY

Shares of CymaBay Therapeutics (CBAY) soared to an all-time high Monday after Gilead Sciences (GILD) announced it's buying the developer of medicine for liver and other chronic diseases for $4.3 billion.

Why Gilead Sciences Is Buying CymaBay Therapeutics for $4.3 Billion

MILWAUKEE , Feb. 12, 2024 /PRNewswire/ -- Ademi LLP is investigating CymaBay (Nasdaq: CBAY)  for possible breaches of fiduciary duty and other violations of law in its transaction with Gilead. Click here to learn how to join the https://www.ademilaw.com/case/cymabay-therapeutics-inc or call Guri Ademi toll-free at 866-264-3995.

Shareholder Alert: Ademi LLP investigates whether CymaBay Therapeutics, Inc. has obtained a Fair Price in its transaction with Gilead

CymaBay (NASDAQ: CBAY ) stock is rising higher on Monday after the clinical-stage biopharmaceutical company announced an acquisition agreement with Gilead Sciences (NASDAQ: GILD ). That deal has Gilead Sciences agreeing to acquire CymaBay for $4.3 billion.

Why is CymaBay (CBAY) Stock Up 25% Today?

CymaBay Therapeutics shares jumped nearly 25% and hit a new record high in early trading after the clinical-stage biopharmaceutical company agreed to be acquired by Gilead Sciences for $4.3 billion.

CymaBay Therapeutics Shares Hit All-Time High on Gilead Deal

NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating whether the sale of CymaBay Therapeutics, Inc. (NASDAQ: CBAY) to Gilead Sciences, Inc. for $32.50 per share in cash is fair to CymaBay shareholders. Halper Sadeh encourages CymaBay shareholders to click here to learn more about their legal rights and options or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or sadeh@halpersadeh.com or zhalper@halpersadeh.com. The investigation concerns whether C.

CBAY Stock Alert: Halper Sadeh LLC Is Investigating Whether the Sale of CymaBay Therapeutics, Inc. Is Fair to Shareholders

CymaBay Therapeutics Inc (NASDAQ: CBAY) opened more than 25% up this morning after Gilead Sciences Inc (NASDAQ: GILD) said it will buy the biopharmaceutical company for $4.3 billion. Details of Gilead-CymaBay agreement The said deal values CymaBay at $32.50 per share.

Gilead to buy CymaBay Therapeutics for $4.3 billion

CymaBay stock skyrocketed Monday after Gilead Sciences announced it will buy it for $4.3 billion. CBAY stock surged almost 25%.

CymaBay Stock Rockets After Gilead Sciences Unveils $4.3 Billion Acquisition

-  FDA has granted Priority Review with a target PDUFA date of August 14 - NEWARK, Calif. , Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid.

CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar for the Treatment of Primary Biliary Cholangitis

Gilead Sciences on Monday said it will acquire CymaBay Therapeutics for $4.3 billion, to expand its portfolio of liver disease drugs.

Drugmaker Gilead to acquire CymaBay for $4.3 bln

Gilead Sciences Inc. GILD, -0.18% said Monday it has reached a deal to acquire CymaBay Therapeutics Inc. CBAY, +2.92% for $32.50 per share in cash, a 27% premium to CymaBay's closing price Friday, for a total deal equity value of $4.3 billion. CymaBay's lead asset is seladelpar, an investigational treatment for primary biliary cholangitis, a type of liver disease that causes bile-duct damage.

Gilead strikes deal to acquire CymaBay for $4.3 billion

FOSTER CITY, Calif. & NEWARK, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion. The addition of CymaBay's investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead's existing liver portfolio and aligns wit.

Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

NEWARK, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that members of its management team will participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference, February 7-8, in New York, NY, Raymond James & Associates' 45th Annual Institutional Investors Conference, March 4-6, in Orlando, Florida, and Leerink Partners Global Biopharma Conference, March 11-13, in Miami, Florida.

CymaBay Therapeutics to Participate in Upcoming Investment Conferences

-- First clinical trial in PBC to show coordinate reductions of IL-31, bile acids and pruritus -- NEWARK, Calif. , Jan. 3, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced the first published findings demonstrating the impact of seladelpar on serum interleukin-31 (IL-31) levels and its correlation with pruritus improvement in people with primary biliary cholangitis (PBC).

New Published Data Demonstrates Correlation Between Itch Cytokine Interleukin-31 Reduction and Pruritis Improvement in Primary Biliary Cholangitis in Phase 3 Post-Hoc Analysis of CymaBay's Seladelpar

NEWARK, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that its President and Chief Executive Officer, Sujal Shah, will present at the upcoming 42nd Annual JP Morgan Healthcare Conference taking place January 8 -11 in San Francisco, California.

CymaBay Therapeutics to Present at the 42nd Annual JP Morgan Healthcare Conference 2024

CymaBay is sprinting to the finish line with a treatment for a serious liver disease and CBAY stock is on a massive run.

Why CymaBay Morphed From Dollar Stock To Biotech Rocket

- NDA is supported by data evaluating seladelpar efficacy and safety in over 500 patients -  - Seladelpar is the first New Drug Application from CymaBay in its ongoing mission to help people living with PBC -  NEWARK, Calif. , Dec. 15, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational treatment, seladelpar, for the management of primary biliary cholangitis, including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA).

CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis

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61.7% of patients on seladelpar 10 mg achieved the primary composite endpoint vs. 20.0% of patients on placebo (p

CymaBay Announces an Oral Presentation of Seladelpar Phase 3 Pivotal Results in Primary Biliary Cholangitis at the Late Breaker Session of the Liver Meeting®

News for CymaBay Therapeutics Stock (CBAY)