NEWARK, Calif., Nov. 10, 2016 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for indications with high unmet medical need, including rare and orphan diseases, announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for MBX-8025 to treat patients with primary biliary cholangitis (PBC). MBX-8025 is a potent and selective peroxisome proliferator-activated receptor delta (PPARd) agonist being evaluated by CymaBay in high unmet need and orphan diseases. The FDA has also granted orphan drug designation for MBX-8025 to treat patients with homozygous familial hypercholesterolemia (HoFH) and hyperlipoproteinemia types I or V (Fredrickson classification). Orphan drug designation was created to encourage the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Among other benefits, the designation potentially qualifies the sponsor for seven years marketing exclusivity period upon approval, as well as exemption from FDA application fees, and tax credits for qualified clinical trials. "This orphan drug designation is a validation of the company's development strategy for MBX-8025 in which we are targeting indications with high unmet need and potentially expedited approval pathways," said Dr. Harold Van Wart, President and Chief Executive Officer of CymaBay. "MBX-8025 potentially offers unique benefits for the treatment of PBC and we remain on track to initiate a follow on Phase 2 study of MBX-8025 in PBC this quarter." About PBCPrimary biliary cholangitis (PBC), formerly known as primary biliary cholestasis, is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids. There is an accompanying inflammation and destruction of the intrahepatic bile ducts which can progress to fibrosis, cirrhosis and liver failure. Other clinical symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC is primarily a disease of women, afflicting approximately one in 1,000 over the age of 40.