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March 10, 2014
08:50 EDTKERXKeryx announces submission of MAA for Zerenex to EMA
Keryx Biopharmaceuticals announced it has submitted a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease, or CKD, including dialysis- and non-dialysis dependent CKD. The MAA will be reviewed by the EMA Committee for Medicinal Products for Human Use and the review will be conducted under the Centralized Authorization Procedure. An approval under the Centralized Authorization Procedure provides one marketing authorization which is valid in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
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July 24, 2014
17:17 EDTKERXKeryx up 3% in after hours trading after Zerenex meets phase 3 primary end-point
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