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.

NEWARK, Calif., Aug. 05, 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 Thursday, August 12, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the second quarter ended June 30, 2021 and to provide a business update.

CymaBay Therapeutics to Report Second Quarter 2021 Financial Results on Thursday, August 12, 2021

CymaBay Therapeutics Inc (NASDAQ: CBAY) has received $100 million in non-dilutive financing from Abingworth to fund the Phase 3 development program for seladelpar in primary biliary cholangitis (PBC). Under the terms of the transaction, CymaBay will receive up to $100 million of seladelpar development costs, of which $75 million will be received in three installments over approximately six months.

CymaBay Secures $100M Non-Dilutive Funding To Fund Seladelpar Development Program

Risk-sharing agreement with Abingworth will fund seladelpar Phase 3 development program for PBC

CymaBay Announces $100 Million Non-Dilutive Financing with Abingworth

Cymabay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q1 2021 Results - Earnings Call Transcript

Highly experienced executives, Dr. Dennis Kim as Chief Medical Officer and Lewis Stuart as Chief Commercial Officer, strengthen the management team

CymaBay Reports First Quarter 2021 Financial Results and Provides Corporate Update

Proven Leader in Building Commercial Organizations to Prepare Markets and Deliver Successful Product Launches  Planning for Seladelpar Launch as it Completes Development and Regulatory Submissions

CymaBay Names Lewis Stuart Chief Commercial Officer

NEWARK, Calif., April 05, 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 the appointment of biopharma veteran Thomas Wiggans and commercial leader Janet Dorling to its Board of Directors. Concurrently with these appointments, CymaBay announced that Paul F. Truex has resigned from the Board of Directors effective as of April 1, 2021 to focus on his new role as Chief Executive Officer of LQT Therapeutics.

CymaBay Appoints Thomas Wiggans and Janet Dorling to Board of Directors

Cymabay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q4 2020 Results - Earnings Call Transcript

Actively recruiting patients in two global, clinical studies evaluating seladelpar in primary biliary cholangitis (PBC):

CymaBay Reports Fourth Quarter and Year End 2020 Financial Results and Provides Corporate Update

NEWARK, Calif., March 12, 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 Thursday, March 25, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the fourth quarter and year ended December 31, 2020 and to provide a business update.

CymaBay Therapeutics to Report Fourth Quarter and Full Year 2020 Financial Results on Thursday, March 25, 2021

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NEWARK, Calif., Nov. 16, 2020 (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 an oral late-breaking presentation of the positive results from the ENHANCE phase 3 study evaluating seladelpar for primary biliary cholangitis (PBC). These data were presented online today during the late-breaking session at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD).

CymaBay Therapeutics Announces Oral Late-Breaking Presentation of Positive Results from the ENHANCE Global Phase 3 Study Evaluating Seladelpar for Primary Biliary Cholangitis at The Liver Meeting® 2020

The FDA lifted all holds on all CymaBay liver disease studies back in July, since, shares have begun clawing back, +319% upside YTD. The company has presented positive top-line data from the ENHANCE study for Seladelpar, which shows high conversion potential in a complex chronic disease segment.

CymaBay Is Clawing Back, Now We Just Need Pipeline Conversion

CymaBay Therapeutics (CBAY) CEO Sujal Shah on Q3 2020 Results - Earnings Call Transcript

The AdventHealth Translational Research Institute (TRI) in Orlando, FL to lead the study, funded by the Helmsley Charitable Trust, evaluating MBX-2982, a GPR119 agonist, for its ability to increase secretion of glucagon, a hormone that reverses low blood glucose levels (hypoglycemia) in individuals with type 1 diabetes (T1D) The AdventHealth Translational Research Institute (TRI) in Orlando, FL to lead the study, funded by the Helmsley Charitable Trust, evaluating MBX-2982, a GPR119 agonist, for its ability to increase secretion of glucagon, a hormone that reverses low blood glucose levels (hypoglycemia) in individuals with type 1 diabetes (T1D)

CymaBay Announces Study to Evaluate the Potential for GPR119 Agonists to Prevent Hypoglycemia in Type 1 Diabetes

NEWARK, Calif., Oct. 30, 2020 (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, November 5, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter and nine months ended September 30, 2020 and to provide a business update.

CymaBay Therapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020

Investors need to pay close attention to CymaBay Therapeutics (CBAY) stock based on the movements in the options market lately.

Implied Volatility Surging for CymaBay Therapeutics (CBAY) Stock Options

NEWARK, Calif., Aug.  27, 2020  (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 final results from a previously completed open-label Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC). These data will be made available as an electronic presentation through the Digital International Liver Congress™ 2020 of the European Association for the Study of Liver (EASL) which will be held online August 27th – 29th and were selected for inclusion in the “Best of ILC” presentation.

CymaBay Therapeutics Presents Positive Final Results From 52-Week Phase 2 Study in Primary Biliary Cholangitis at The Digital International Liver Congress™ 2020

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CymaBay Therapeutics, Inc.'s (CBAY) CEO Sujal Shah on Q2 2020 Results - Earnings Call Transcript

NEWARK, Calif., Aug.  03, 2020  (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, August 10, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the second quarter and six months ended June 30, 2020 and to provide a business update.

CymaBay Therapeutics to Report Second Quarter 2020 Financial Results on Monday, August 10, 2020

CymaBay Therapeutics Inc. (NASDAQ: CBAY) posted a huge gain to start the week after the company reported results from a late-stage clinical study for the treatment of primary biliary cholangitis (PBC).

CymaBay Pulls Off Another Win With PBC Liver Disease Study

Clinical hold lifted on seladelpar INDs in NASH, PBC and PSC 

FDA Lifts All Clinical Holds on Seladelpar

Data from previously completed open-label phase 2 study supports potential for seladelpar to improve pruritus (itching) in patients with PBC

CymaBay Therapeutics Presents Data at Digestive Disease Week 2020 Online Education

Investors need to pay close attention to CymaBay (CBAY) stock based on the movements in the options market lately.

News for CymaBay Therapeutics Stock (CBAY)