Cymabay Therapeutics, Inc. CBAY announced that it has successfully completed the end-of-phase II meeting with the FDA for the phase III development program on arhalofenate.
Arhalofenate is being developed in combination with Uloric (febuxostat) for the treatment of patients suffering from gout.
The phase III program, which is scheduled to commence this year, includes three phase III studies that will evaluate patients (n~1300) for at least 12 months. The arhalofenate-febuxostat combination will be evaluated in patients with chronic gout in two studies and in patients with tophaceous gout in the third study.
Current players in the market include Mitigare and Colcrys, among others. We remind investors that last month, the FDA has approved another drug, AstraZeneca plc’s AZN Zurampic (200mg), for use in combination with a xanthine oxidase inhibitor (XOI).
Meanwhile, Cymabay continues to progress with other candidates in its pipeline. At present, the company is evaluating MBX-8025 in two phase II studies for the treatment of patients with homozygous familial hypercholesterolemia and the treatment of patients with primary biliary cholangitis. Top-line data from the homozygous familial hypercholesterolemia study is expected in the first quarter of 2016.
Cymabay currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Ligand Pharmaceuticals Incorporated LGND and Anika Therapeutics Inc. ANIK, both sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
LIGAND PHARMA-B (LGND): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis Report
CYMABAY THERAPT (CBAY): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research