NEWARK, CA -- (Marketwired) -- 04/20/15 -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced the appointment of Kirk Rosemark to Vice President of Regulatory Affairs and Quality Assurance, effective April 27, 2015. Mr. Rosemark will report directly to Harold Van Wart, CymaBay's Chief Executive Officer.
Mr. Rosemark comes to CymaBay with 20 years of regulatory affairs experience. He served as VP of Regulatory Affairs and Quality Assurance for Exelixis, Inc., where he played a key role in the clinical development and approval of COMETRIQ™ (cabozantinib). Prior to that, Mr. Rosemark served as VP, Regulatory Affairs at NeoPharm and Director of Regulatory Affairs at Unimed Pharmaceuticals, Inc. following its acquisition by Solvay Pharmaceuticals.
"We are very pleased that Kirk will be joining our team, significantly strengthening our in-house expertise," said Harold Van Wart, President and Chief Executive Officer of CymaBay. "His proven track record in regulatory affairs will be invaluable to us as we work to develop the clinical and regulatory strategies for our products. We are planning an end-of-phase 2 meeting with the FDA for arhalofenate later this year in preparation for the start of Phase 3 in early 2016. Kirk's prior experience developing products for orphan and high unmet need indications will also be of great help as we move MBX-8025 forward in homozygous familial hypercholesterolemia and other rare metabolic disorders."
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. Arhalofenate, the company's lead product candidate, has shown two therapeutic actions in a single drug in multiple Phase 2 gout studies. In gout patients, arhalofenate is intended to prevent painful flares in joints while at the same time promoting excretion of uric acid by the kidney, thereby addressing both the signs and symptoms of gout and the hyperuricemia that is the root cause of the disease. CymaBay's second product candidate, MBX-8025 is a potent, selective, orally active PPARδ agonist. A Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay is in the process of initiating a pilot study of MBX-8025 in patients with homozygous familial hypercholesterolemia.
For additional information about CymaBay visit www.cymabay.com.
CymaBay Therapeutics, Inc.
Source: CymaBay Therapeutics