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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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January 21, 2015
19:55 EDTKERXKeryx 9.17M share Secondary priced at $12.00
The deal size was raised to 9.17M shares from 7.2M shares. JPMorgan acted as sole book running manager for the offering.
January 20, 2015
18:30 EDTKERXOn The Fly: After Hours Movers
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16:06 EDTKERXKeryx files to sell $100M in common stock
J.P. Morgan is acting as the sole book-running manager in the offering. Keryx intends to use the net proceeds from the sale of its common stock to fund the ongoing commercialization and development of Auryxia in the US, pre-commercial activities in Europe, to potentially in-license, acquire and develop additional drug candidates, and other general corporate purposes.

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