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., Sept.  03, 2019  (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, today announced that senior management will participate in three investor conferences in September, including Citi’s 14th Annual Biotech Conference, H.C. Wainwright 21st Annual Global Investment Conference and Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies.

CymaBay Therapeutics to Present at Upcoming Investor Conferences in September

Primary Sclerosing Cholangitis is an orphan disease with no FDA approved therapeutic options or viable alternatives except surgical interventions.

CymaBay And Seladelpar In PSC: The Imminent Phase 2 Study

Cymabay Therapeutics, Inc. (CBAY) CEO Sujal Shah on Q2 2019 Results - Earnings Call Transcript

Seladelpar is a specific, new generation PPAR-δ agonist in mid-late phase clinical development for NASH and cholestatic liver diseases, PBC and PSC.

CymaBay And Seladelpar In Phase 3 PBC: The Sprint To The Finish Line

CymaBay Therapeutics tumbled on reporting 12-week data from its phase 2b study using seladelpar to treat patients with nonalcoholic steatohepatitis.

CymaBay Tumbles On NASH Data, But One Must Take A Closer Look To Get The Full Picture

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CymaBay (CBAY) plummets as a phase IIb study on lead candidate, seladelpar, fails to show meaningful reductions in liver fat.

CymaBay Down on Dismal Interim Data From Mid-Stage NASH Study

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The company reported disappointing interim data from an ongoing phase 2b trial in NASH, but it wasn't all bad news.

Here's Why CymaBay Therapeutics Collapsed Today

CymaBay Therapeutics Inc. (NASDAQ: CBAY) shares were nearly halved in Tuesday’s premarket trading after the company provided an update from its midstage study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH).

Is CymaBay Therapeutics’ Liver Disease Trial Sunk?

Shares of CymaBay Therapeutics Inc.  plummeted 43% in premarket trade Tuesday after the biotech said data from an ongoing Phase 2 trial showed patients with nonalcoholic steatohepatitis (NASH) who were treated with investigational drug seladelpar did not show significant reductions in liver fat when compared with those on a placebo.

CymaBay Therapeutics stock down 43% after NASH trial data disappoint investors

CymaBay Therapeutics (NASDAQCBAY) announced results from an ongoing 52-week Phase 2b dose-ranging, paired liver biopsy study of "seladelpar" for the treatment of nonalcoholic steatohepatitis.

CymaBay Therapeutics Plummets 40% Following Liver Disease Data

Billionaire investor Steven Cohen (Trades, Portfolio), leader of Point72 Asset Management, disclosed a 6.3% stake in CymaBay Therapeutics Inc.

Steven Cohen Takes an Interest in CymaBay Therapeutics

CBAY has a phase 3 trial ongoing in PBC, for lead drug candidate seladelpar, a PPAR delta agonist.

CymaBay Therapeutics: Targeting Primary Biliary Cholangitis And Then Onto NASH

CymaBay Therapeutics (CBAY) needs investors to pay close attention to the stock based on moves in the options market lately.

Options Traders Expect Huge Moves in CymaBay Therapeutics (CBAY) Stock

CymaBay is expected to announce the 12-week interim data readout on liver fat reduction in biopsied NASH patients treated with seladelpar imminently.

CymaBay And Seladelpar In NASH: An Aged Wine Ripe For Success

CymaBay Therapeutics' (CBAY) CEO Sujal Shah on Q1 2019 Results - Earnings Call Transcript

CymaBay recently announced that it had completed enrollment of patients with NASH in the Phase 2b study of seladelpar.

News for CymaBay Therapeutics Stock (CBAY)