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.

Primary composite endpoint at 12 months of serum alkaline phosphatase and bilirubin was met by 61.7% of patients treated with seladelpar 10 mg vs. 20.0% of placebo treated patients (p

CymaBay's Seladelpar Achieves High Statistical Significance for the Primary and Key Secondary Endpoints in the Phase 3 RESPONSE Trial in Primary Biliary Cholangitis

NEWARK, Calif., Sept. 06, 2023 (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 host an investor call on Thursday, September 7 at 8:00 a.m. ET to share topline results from the Phase 3 pivotal RESPONSE study of seladelpar in patients with primary biliary cholangitis (PBC).

CymaBay to Host Investor Call to Share Topline Results from the Phase 3 RESPONSE Trial of Seladelpar in Primary Biliary Cholangitis on September 7, 2023

Top-line data from RESPONSE Phase 3 study in PBC expected by end of September 2023 IDEAL clinical trial actively recruiting Conference call and webcast today at 4:30 p.m. ET NEWARK, Calif.

CymaBay Reports Second Quarter and Six Months Ended June 30, 2023 Financial Results and Provides Corporate Update

Evaluates seladelpar 10 mg vs. placebo for alkaline phosphatase normalization at 52 weeks Patients enroll with alkaline phosphatase levels between 1- and 1.67-times upper limit of normal NEWARK, Calif.

CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar in Patients with Primary Biliary Cholangitis and Incomplete Control of Alkaline Phosphatase

NEWARK, Calif., Aug. 03, 2023 (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, announced today that it will host a conference call and live audio webcast on Thursday, August 10, 2023 at 4:30 p.m. Eastern Time to discuss financial results for the second quarter ended June 30, 2023 and to provide a business update.

CymaBay Therapeutics to Report Second Quarter of 2023 Financial Results on Thursday, August 10, 2023

CymaBay Therapeutics' primary candidate, seladelpar, shows promising results as a potential treatment for primary biliary cholangitis, a liver autoimmune disease. Seladelpar demonstrated significant anti-cholestatic, anti-inflammatory, and anti-pruritic activity in Phase 2 and ENHANCE Phase 3 studies, improving patient quality of life. The ongoing RESPONSE Phase 3 study is critical for the company, with results potentially cementing seladelpar's position as a leading treatment option for PBC.

CymaBay's Seladelpar: An Exceptional PPAR Agonist Candidate For PBC

CymaBay Therapeutics Inc. (CBAY) could be a solid choice for shorter-term investors looking to capitalize on the recent price trend in fundamentally sound stocks. It is one of the many stocks that passed through our shorter-term trading strategy-based screen.

Recent Price Trend in CymaBay Therapeutics Inc. (CBAY) is Your Friend, Here's Why

CymaBay is a clinical-stage biotech. The company focuses on liver diseases and other chronic diseases.

Why Shares of CymaBay Therapeutics Are Soaring Friday

Additional data presented at The International Liver Congress™ 2023 show clinical risk factors for PBC disease progression present in a broader population of UDCA-treated PBC patients Preclinical data points to need for the study of novel pathways mediated by seladelpar and their role in reducing fibrosis NEWARK, Calif. , June 21, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today new findings from a post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC) demonstrating baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31.

CymaBay Therapeutics Presents Data Showing Seladelpar Treatment in Primary Biliary Cholangitis (PBC) Correlates with Alleviation of Self-Reported Pruritus and Reduction in Serum IL-31 Levels

Two abstracts focus on the unique mechanism of action of seladelpar; a third focuses on characterizing patient risk of PBC disease progression NEWARK, Calif. , June 7, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with significant unmet need, today announced it will make three presentations at the European Association for the Study of the Liver (EASL)'s The International Liver Congress™ 2023.

CymaBay Therapeutics to Present New Data Highlighting Seladelpar's Unique Activity in Patients with Primary Biliary Cholangitis at The International Liver Congress™ 2023

The clinical-stage liver and other chronic disease specialist published its first-quarter results, which included a business update. The company's net loss was deeper than analysts expected.

Why CymaBay Therapeutics Stock Nose-Dived This Week

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CymaBay Therapeutics Inc. (CBAY) Is a Great Choice for 'Trend' Investors, Here's Why

CymaBay Therapeutics, Inc. (NASDAQ:CBAY ) Q1 2023 Earnings Conference Call May 15, 2023 4:30 PM ET Company Participants Paul Quinlan - General Counsel Sujal Shah - President and Chief Executive Officer Charles McWherter - Chief Scientific Officer and President, Research and Development Lewis Stuart - Chief Commercial Officer Dan Menold - Vice President, Finance Conference Call Participants Yasmeen Rahimi - Piper Sandler Steve Seedhouse - Raymond James Kristen Kluska - Cantor Fitzgerald Patrick Dolezal - LifeSci Capital Julian Harrison - BTIG Andy Hsieh - William Blair Jay Olson - Oppenheimer Mayank Mamtani - B. Riley Operator Good day, ladies and gentlemen, and welcome to CymaBay's First Quarter 2023 Financial Results and Business Update Conference Call.

CymaBay Therapeutics, Inc. (CBAY) Q1 2023 Earnings Call Transcript

Harish Shantharam, proven leader in building financial organizations to prepare for successful commercialization, appointed as Chief Financial Officer

CymaBay Reports First Quarter 2023 Financial Results and Provides Corporate Update

NEWARK, Calif., May 10, 2023 (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 that it will host a conference call and live audio webcast on Monday, May 15, 2023 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2023 and to provide a business update.

CymaBay Therapeutics to Report First Quarter of 2023 Financial Results on Monday, May 15, 2023

Today, we shine the spotlight on CymaBay Therapeutics, Inc., whose stock has had a big rally in 2023. The company is advancing its lead asset Seladelpar towards approval and recently signed a licensing deal in Japan, but cash burn remains a concern.

CymaBay Therapeutics: Slow But Steady Progress

Proven Leader in Building Financial Organizations to Prepare Company for Successful Commercialization Planning for Seladelpar Launch as it Completes Development and Regulatory Submissions NEWARK, Calif., May 09, 2023 (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 that seasoned biopharma executive Harish Shantharam, CFA has joined the company as Chief Financial Officer.

CymaBay Names Harish Shantharam Chief Financial Officer

NEWARK, Calif., April 21, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that results from the ENHANCE phase 3 global study evaluating seladelpar for primary biliary cholangitis (PBC) have been published in Hepatology:

CymaBay Therapeutics Announces Publication of Results From the ENHANCE, Phase 3 Study of Seladelpar in Patients with Primary Biliary Cholangitis (PBC)

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NEWARK, Calif., April 17, 2023 (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 that management will participate in the H.C. Wainwright BioConnect Investor Conference at NASDAQ.

CymaBay Therapeutics to Present at the H.C. Wainwright BioConnect Investor Conference at NASDAQ

Here's Why Momentum in CymaBay Therapeutics Inc. (CBAY) Should Keep going

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The consensus price target hints at a 40.3% upside potential for CymaBay Therapeutics Inc. (CBAY). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Predict a 40.32% Upside in CymaBay Therapeutics Inc. (CBAY): Here's What You Should Know

CymaBay Therapeutics, Inc. (NASDAQ:CBAY ) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET Company Participants Paul Quinlan - General Counsel Sujal Shah - Chief Executive Officer Chuck McWherter - President, Research & Development and Chief Scientific Officer Lewis Stuart - Chief Commercial Officer Dan Menold - Vice President, Finance Conference Call Participants Yasmeen Rahimi - Piper Sandler Steven Seedhouse - Raymond James Kristen Kluska - Cantor Fitzgerald Ed Arce - H.C. Wainwright Jay Olson - Oppenheimer Julian Harrison - BTIG Operator Good day ladies and gentlemen and welcome to CymaBay's Fourth Quarter and Full-Year 2022 Financial Results and Business Update Conference Call.

CymaBay Therapeutics, Inc. (CBAY) Q4 2022 Earnings Call Transcript

Conference call and webcast today at 4:30 p.m. ET Conference call and webcast today at 4:30 p.m. ET

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