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cymabay therapeutics inc (CBAY) Snapshot

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cymabay therapeutics inc (CBAY) Details

Cymabay Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery and development of various therapies for the treatment of gout and metabolic diseases. Its products include Arhalofenate, which is in Phase IIb clinical study for the treatment of gout; MBX-8025, a selective agonist for disorders linked to defects in lipid storage, handling, and utilization, which has completed five Phase I clinical studies and one Phase II clinical study; and MBX-2982, an oral G-protein coupled receptor agonist to treat type 2 diabetes mellitus (T2DM), which has completed four Phase I clinical studies and one Phase II clinical study. Cymabay Therapeutics, Inc. has a strategic alliance with Ortho-McNeil, Inc.; development and license agreements with Janssen Pharmaceuticals, Inc. to develop and discover undisclosed metabolic disease target agonists for the treatment of T2DM and other disorders; and a license and development agreement with DiaTex, Inc. to develop and commercialize therapeutic products containing halofenate its enantiomers, derivatives, and analogs. Cymabay Therapeutics, Inc. was formerly known as Metabolex, Inc. The company was incorporated in 1988 and is based in Newark, California.

16 Employees
Last Reported Date: 11/14/14
Founded in 1988

cymabay therapeutics inc (CBAY) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $481.5K
Chief Financial Officer, Principal Financial ...
Total Annual Compensation: $13.8K
Chief Scientific Officer and Senior Vice Pres...
Total Annual Compensation: $366.0K
Compensation as of Fiscal Year 2013.

cymabay therapeutics inc (CBAY) Key Developments

CymaBay Therapeutics Announces Preclinical Data Demonstrating the Potential of MBX-8025 to Treat Homozygous Familial Hypercholesterolemia

CymaBay Therapeutics announced results from a preclinical study indicating the potential for MBX-8025 to decrease low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). MBX-8025 is a potent and selective peroxisome proliferator-activated receptor delta agonist that, in previous clinical studies, has been shown to reduce LDL-C in patients with mixed dyslipidemia. CymaBay believes that MBX-8025 has the potential to markedly improve the lipid profile of patients with various forms of dyslipidemia, including HoFH. HoFH is a rare, life-threatening, autosomal genetic disease characterized by loss-of-function mutations in both alleles of the LDL receptor (LDL-R) gene. This loss of LDL-R activity results in marked elevations in the plasma levels of LDL-C causing premature cardiovascular disease that often presents during the first decades of life and which can result in myocardial infarction, ischemic stroke and premature death. Patients with HoFH generally respond poorly to conventional cholesterol lowering drugs because their activities depend directly or indirectly on LDL-R activity. Data from the preclinical study described below support the hypothesis that the LDL-C lowering activity of MBX-8025 is not dependent on having a fully functional LDL-R. Based on these data, CymaBay is in the process of initiating a pilot clinical study evaluating the activity of MBX-8025 in patients with HoFH. The Watanabe-heritable hyperlipidemic (WHHL) rabbit is a preclinical model of HoFH that is characterized by low (< 5%) hepatic LDL-R activity, highly elevated LDL-C and the accompanying development of atherosclerosis. In this study, five WHHL rabbits with highly elevated baseline plasma LDL-C levels (360-592 mg/dL) were dosed by subcutaneous administration of MBX-8025 (30 mg/kg) once daily for three weeks, followed by a four-week washout period. LDL-C concentrations were measured once weekly during treatment (weeks 1-3) and after washout of MBX-8025 (week 7). Treatment with MBX-8025 resulted in changes from baseline in mean LDL-C of -33, -45 and -42% at weeks 1, 2 and 3, respectively. All animals experienced absolute decreases in LDL-C (114-302 mg/dL; p < 0.01 for all changes vs. baseline). Furthermore, this LDL-C lowering effect of MBX-8025 was completely reversed after a washout period of 4 weeks. MBX-8025 is a potent and selective agonist of PPARD, a nuclear receptor important for lipid transport, storage and metabolism in liver and muscle. MBX-8025 has shown favorable effects on lipid and metabolic parameters in a Phase 2 study in patients with mixed dyslipidemia. Treatment effects observed include lowering of LDL-C with selective depletion of pro-atherogenic dense LDL-C particles, decreases in triglycerides and increases in high density lipoprotein, as well as decreases in hsCRP, a biomarker of cardiovascular inflammation. CymaBay is in the process of initiating a pilot clinical study evaluating the activity of MBX-8025 in patients with homozygous familial hypercholesterolemia.

Cymabay Therapeutics Announces Positive Results from its Phase 2 Clinical Study of Arhalofenate in Combination with Febuxostat

CymaBay Therapeutics Inc. announced positive preliminary results from its clinical study of arhalofenate administered in combination with febuxostat (Uloric™, Takeda Pharmaceutical Company Limited). Arhalofenate is a once-daily, oral candidate for the treatment of gout with a unique dual mechanism of action which lowers serum uric acid (sUA) while also reducing the occurrence of gout flares. Current treatment guidelines for gout recommend the use of urate lowering drugs to reverse hyperuricemia in order to remove deposits of proinflammatory urate crystals. The minimal goal of this treatment is to reduce sUA levels to below 6 mg/dL; reducing sUA values to below 5 or 4 mg/dL is particularly desirable for patients with advanced disease in order to dissolve urate deposits (known as tophi) within a practical timeframe. Many patients treated with currently marketed xanthine oxidase inhibitors (allopurinol or febuxostat) alone do not reach these goals. Arhalofenate blocks the reabsorption of uric acid in the proximal tubules of the kidney by inhibiting a renal uric acid transporter called URAT1. This leads to the excretion of uric acid into the urine (a uricosuric effect) that could provide additional sUA lowering when used in combination with xanthine oxidase inhibitors. In an earlier study, CymaBay showed that the combination of arhalofenate (400 and 600 mg) and febuxostat (80 mg) markedly lowered sUA in gout patients. In the present Phase 2 clinical study, the sUA lowering of additional combinations of arhalofenate (600 and 800 mg) and febuxostat (40 and 80 mg) were evaluated. In addition, data have been collected to understand the time course of the uricosuric effect. Arhalofenate has a long serum half-life (~50 hours) and serum levels reach steady state gradually. The time course of changes in sUA, urinary uric acid (uUA) and the fractional excretion of uric acid (FEUA) as monotherapy have been examined over the first 2 weeks. Analysis of arhalofenate and febuxostat drug levels to assess for a potential drug-drug interaction is underway and will be reported in a subsequent communication.

Cymabay Therapeutics, Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015

Cymabay Therapeutics, Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015 . Venue: The Handlery Hotel, 351 Geary Street, Union Square, San Francisco, California, United States.


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