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December 6, 2013
07:48 EDTKERXKeryx selloff creates buying opportunity, says Oppenheimer
After a tweet from stated that Keryx's Zerenex would probably not get New Chemical Entity status and the stock fell sharply in response, Oppenheimer believes there is a high probability that the FDA will grant such status. But the firm thinks the status is not material to the stock's valuation, and it reiterates an Outperform rating on the shares.
News For KERX From The Last 14 Days
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April 9, 2014
11:22 EDTKERXKeryx June volatility elevated into PDUFA
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08:35 EDTKERXKeryx Zerenex phase 2 data presentation selected for Kidney Foundation meeting
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April 2, 2014
09:22 EDTKERXKeryx price target raised to $34 from $25 at Mizuho
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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.

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