Stock Monitor: Can-Fite BioPharma Post Earnings Reporting
LONDON, UK / ACCESSWIRE / April 13, 2018 / Active-Investors.com has just released a free research report on CymaBay Therapeutics, Inc. (NASDAQ: CBAY) ("CymaBay"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CBAY as the Company's latest news hit the wire. On April 11, 2018, the Company announced that it will present new data from a second interim analysis of its ongoing Phase-2 study assessing seladelpar in patients with primary biliary cholangitis (PBC) at the International Liver CongressTM hosted by the European Association for the Study of Liver Diseases (EASL) in Paris, France (April 11-15, 2018). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, CymaBay Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
Seladelpar Maintains Anti-Cholestatic and Anti-Inflammatory Efficacy Over 26 Weeks of Administration
These data demonstrate that in patients with PBC, seladelpar exhibits potent and sustained anti-cholestatic and anti-inflammatory efficacy over 26 weeks of administration. 71 patients were exposed to at least one dose of seladelpar, of whom 53 received 12 weeks of treatment and 42 received 26 weeks of treatment. At 12 weeks, changes in alkaline phosphatase (AP) were -21%, -33%, and -45% in the 2 mg, 5 mg, and 10 mg groups, respectively. After 12 weeks, dose titration was permitted for patients whose AP remained above normal and at a level where additional AP lowering had the potential to reduce the risk of disease progression. At 26 weeks, decreases in AP were similar across regimens at -45%, -43%, and -43% in the 5 mg, 5 to 10 mg titration and 10 mg groups, respectively. At 26 weeks, 29% of patients had a normal AP. Seladelpar was not associated with drug-induced pruritus. Seladelpar was generally safe and well tolerated, with no transaminase elevation safety signal. There were six serious adverse events, and none were deemed related to seladelpar.
CymaBay to Initiate Phase-3 Study of Seladelpar in H2 2018
Dr. Pol Boudes, M.D., Chief Medical Officer of CymaBay, stated that the Company has now firmly established doses of seladelpar with compelling efficacy and tolerability which is expected to further confirm in a Phase-3 study planned to start in the second half of the year.
Dr. Pol added that these data continue to support the potential for seladelpar to significantly improve treatment options for patients with PBC.
CymaBay to Present New Data Demonstrating Seladelpar's Pharmacokinetic and Pharmacodynamic Profile
The Company will also present new data highlighting the mechanism of action of seladelpar and its pharmacokinetic and pharmacodynamic profile at The International Liver CongressTM. Seladelpar demonstrates multiple beneficial activities that address the underlying pathophysiology of PBC and NASH. The pharmacokinetics of seladelpar in PBC patients supports a once daily dosing regimen, appears to be dose proportional and the level of exposure correlates with its pharmacodynamic activities.
About Primary Biliary Cholangitis
PBC, also known as primary biliary cirrhosis, is an autoimmune disease of the liver. It results from a slow, progressive destruction of the small bile ducts of the liver, causing bile and other toxins to build up in the liver, a condition called cholestasis. Further slow damage to the liver tissue can lead to scarring, fibrosis, and eventually cirrhosis. Common symptoms are tiredness, itching and, in more advanced cases, jaundice. In early cases, there may only be changes in blood tests.
CymaBay Began Enrollment in Long-term Extension Study of Seladelpar in PBC Patients
On January 08, 2018, the Company announced that the first PBC patients were successfully enrolled in the seladelpar long-term extension study (NCT03301506). The extension study is an international Phase-2/3 study that will provide access to long-term seladelpar treatment for patients enrolled in a previous or ongoing study evaluating seladelpar for the treatment of PBC. The objectives of the study are to provide additional long-term safety and efficacy data that will support the seladelpar registration program and to follow patients until registration of seladelpar.
Seladelpar (MBX-8025) is an orally administered, potent, and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in development for PBC and non-alcoholic steatohepatitis (NASH). Seladelpar is uniquely suited as a treatment for liver disease. Preclinical and clinical data support its effect on bile acids synthesis, inflammation, fibrosis, and cellular metabolism.
About CymaBay Therapeutics, Inc.
Headquartered in Newark, California, CymaBay is a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. The Company is focused on developing therapies to treat metabolic diseases with high unmet medical need or serious rare and orphan diseases.
Stock Performance Snapshot
April 12, 2018 - At Thursday's closing bell, CymaBay Therapeutics' stock dropped 2.60%, ending the trading session at $13.09.
Volume traded for the day: 2.38 million shares, which was above the 3-month average volume of 1.26 million shares.
Stock performance in the last three-month – up 35.93%; previous six-month period – up 46.42%; past twelve-month period – up 210.93%; and year-to-date - up 42.28%
After yesterday's close, CymaBay Therapeutics' market cap was at $736.18 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.8% at the end of the session.
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