Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is an emerging, small-cap biopharma company that has a pair of lead compounds in late-stage, Phase 3 development for the treatment of cancer (perifosine) and renal disease (Zerenex) under Special Protocol Assessment (SPA) agreements with the FDA.
Keryx Biopharmaceuticals announced positive top-line results from a Phase 3 study of ferric citrate (Zerenex) by The Company's Japanese partners Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii). Part of an ongoing Phase 3 program for ferric citrate (Zerenex), this study is investigating ferric citrate in the treatment of hyperphosphatemia in end-stage renal disease patients. Ferric Citrate (Zerenex) is also in a Phase 3 clinical trials in the United States.
Chief Executive Officer Ron Bentsur, commented,
"We congratulate our partner, JT/Torii, on their successful Phase 3 study and we are excited by their progress. We are also encouraged about our partner's plans to file their marketing application in Japan within less than a year, similar to our expected timelines for the U.S. NDA and European MAA filings... We are enthusiastic about Zerenex's potential differentiated product profile and its prospects for becoming an important part of the treatment of hyperphosphatemia in dialysis patients worldwide."
Read the full press release here.
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