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April 2, 2014
08:37 EDTKERXKeryx announces EMA validation of MAA for Zerenex
Keryx Biopharmaceuticals announced that the European Medicines Agency, or EMA, has determined that the company's Marketing Authorization Application, or MAA, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease, CKD, including dialysis- and non-dialysis-dependent CKD, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. The EMA's review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, Zerenex will receive marketing authorization in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
News For KERX From The Last 14 Days
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March 26, 2015
08:48 EDTKERXKeryx management to meet with JMP SEcurities
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March 23, 2015
13:43 EDTKERXKeryx mentioned cautiously in a Seeking Alpha Pro article
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March 20, 2015
07:55 EDTKERXKeryx survey results positive, says Oppenheimer
After surveying 50 nephrologists/nurses/dietitians at U.S. dialysis clinics, Oppenheimer reported that dialysis providers it surveyed expect to prescribe Keryx's Auryxia in 11% of new starts and about 12% of switchers . As a result of this data points and other data from the survey, the firm expects Auryxia prescription trends to improve. It keeps an $18 price target and Outperform rating on the shares.

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