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.

Results from the phase 3 RESPONSE study, which is using Seladelpar for the treatment of patients with primary biliary Cholangitis, are expected in 2023. PBC patients treated with Seladelpar over a 2-year period saw a decrease in GLOBE PBC Score and improved transplant-free survival.

CymaBay: Long-Term Potential Based On Prior PBC Trial Results

NEWARK, Calif., June 22, 2022 (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 encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that are being presented at The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th.

CymaBay Therapeutics Presents Positive PBC Data at the International Liver Congress™ 2022

NEWARK, Calif., June 08, 2022 (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 multiple seladelpar presentations will be delivered during The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th.

CymaBay Therapeutics Announces Presentations During The International Liver Congress™ 2022

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NEWARK, Calif., May 23, 2022 (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 new analyses of clinical studies of seladelpar were presented during Digestive Disease Week® (DDW) .

CymaBay Therapeutics Presents New Findings that Seladelpar Treatment of PBC Patients for Two Years Predicts Improved Transplant-Free Survival

CymaBay Therapeutics, Inc. (NASDAQ:CBAY ) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Paul Quinlan - General Counsel Sujal Shah - Chief Executive Officer Dan Menold - Vice President, Finance Charles McWherter - Chief Scientific Officer Conference Call Participants Steven Seedhouse - Raymond James Patrick Dolezal - LifeSci Capital Ed Arce - H.C. Wainwright Jay Olson - Oppenheimer & Company Michael Kratky - SVB Securities Operator Good day, ladies and gentlemen and welcome to the CymaBay's First Quarter 2022 Financial Results and Business Update Conference Call.

CymaBay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q1 2022 Results - Earnings Call Transcript

Over 150 clinical sites now activated in RESPONSE Phase 3 clinical trial

CymaBay Reports First Quarter 2022 Financial Results and Provides Corporate Update

Seladelpar Phase 2 Study Selected for DDW Presidential Plenary Session Seladelpar Phase 2 Study Selected for DDW Presidential Plenary Session

CymaBay Therapeutics Announces Presentations at Digestive Disease Week® 2022

NEWARK, Calif., May 05, 2022 (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 Thursday, May 12, 2022 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2022 and to provide a business update.

CymaBay Therapeutics to Report First Quarter of 2022 Financial Results on Thursday, May 12, 2022

NEWARK, Calif., April 04, 2022 (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 Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) have been published in the Journal of Hepatology:

CymaBay Therapeutics Announces Publication of Results From a 52-Week, Open-Label, Phase 2 Study of Seladelpar in Patients With Primary Biliary Cholangitis

CymaBay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q4 2021 Results - Earnings Call Transcript

NEWARK, Calif., March 17, 2022 (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 appointment of Dr. Éric Lefebvre to its Board of Directors.

CymaBay Announces Appointment of Éric Lefebvre, M.D. to Board of Directors

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

CymaBay Reports Fourth Quarter and Year Ended December 31, 2021 Financial Results and Provides Corporate Update

NEWARK, Calif., March 10, 2022 (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 Thursday, March 17, 2022 at 4:30 p.m. Eastern Time to discuss financial results for the fourth quarter and year ended December 31, 2021 and to provide a business update.

CymaBay Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on Thursday, March 17, 2022

NEWARK, Calif., Feb. 10, 2022 (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 two virtual investor conferences including the 11th Annual SVB Leerink Global Healthcare Conference taking place February 14-18, 2022 and Oppenheimer's 32nd Annual Healthcare Conference taking place March 15-16, 2022.

CymaBay Therapeutics to Present at Upcoming Investor Conferences

CymaBay Therapeutics has made continuous progress advancing its lead asset, seladelpar.

Why I've Taken A 'Starter' Position In CymaBay Therapeutics

CymaBay Therapeutics Inc. (CBAY) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

CymaBay Therapeutics Inc. (CBAY) Moves to Buy: Rationale Behind the Upgrade

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NEWARK, Calif., Nov. 15, 2021 (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 of analyses from two clinical studies of seladelpar were delivered during The Liver Meeting Digital Experience™ 2021 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD).

CymaBay Therapeutics Long-term Open Label Study Finds Treatment with Seladelpar for Two Years Improves Key Liver Biomarkers in Patients with PBC

Webinar on Monday, November 15th, @ 4:30pm EST Webinar on Monday, November 15th, @ 4:30pm EST

CymaBay Therapeutics to Host Post-AASLD Key Opinion Leader Webinar on Seladelpar for Primary Biliary Cholangitis

CymaBay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q2 2021 Results - Earnings Call Transcript

CymaBay Therapeutics Inc. (CBAY) delivered earnings and revenue surprises of -13.79% and -100.00%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

CymaBay Therapeutics Inc. (CBAY) Reports Q3 Loss, Misses Revenue Estimates

Over 100 clinical sites now activated in RESPONSE Phase 3 registration study of seladelpar for patients with primary biliary cholangitis (PBC)

CymaBay Reports Third Quarter and Nine Months Ended September 30, 2021 Financial Results and Provides Corporate Update

NEWARK, Calif., Nov. 03, 2021 (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 Wednesday, November 10, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter ended September 30, 2021 and to provide a business update.

CymaBay Therapeutics to Report Third Quarter 2021 Financial Results on Wednesday, November 10, 2021

Secured up to $100 million of additional development funding through a non-dilutive financing transaction with Abingworth

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