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Keryx Biopharmaceuticals Inc (KERX.OQ)

KERX.OQ on NASDAQ Stock Exchange Capital Market

5.65USD
24 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Keryx says FDA accepts application to expand use of Auryxia
Wednesday, 8 Mar 2017 07:30am EST 

Keryx Biopharmaceuticals Inc : Keryx biopharmaceuticals announces u.s. Fda filing acceptance of supplemental new drug application for auryxia® (ferric citrate) tablets . Keryx biopharmaceuticals announces u.s. Fda filing acceptance of supplemental new drug application for auryxia® (ferric citrate) tablets . Keryx biopharmaceuticals inc- prescription drug user fee act (pdufa) target action date for completion of fda's review is november 6, 2017 .Keryx biopharmaceuticals inc- ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile.  Full Article

Keryx Biopharmaceuticals reports Q4 loss per share $0.32
Wednesday, 1 Mar 2017 07:00am EST 

Keryx Biopharmaceuticals Inc : Keryx Biopharmaceuticals announces fourth quarter and full year 2016 financial results . Q4 loss per share $0.32 . Q4 revenue $9.5 million versus I/B/E/S view $8.4 million .Q4 earnings per share view $-0.25 -- Thomson Reuters I/B/E/S.  Full Article

Keryx Biopharmaceuticals says most patients treated with ferric citrate achieved main goal in phase 3 trial
Thursday, 17 Nov 2016 10:31am EST 

Keryx Biopharmaceuticals Inc : Keryx Biopharmaceuticals announces multiple scientific presentations of phase 3 trial results of ferric citrate for iron deficiency anemia (IDA) in non-dialysis dependent chronic kidney disease (NDD-CKD) . Data demonstrate that in phase 3 trial, majority of patients treated with ferric citrate achieved the main goal . Pivotal phase 3 data showed potential of ferric citrate (auryxia) to treat IDA in adults with NDD-CKD .Ferric citrate was well tolerated with up to 16 weeks of dosing.  Full Article

Keryx Biopharmaceuticals announces third quarter 2016 financial results
Wednesday, 9 Nov 2016 07:01am EST 

Keryx Biopharmaceuticals Inc : Keryx Biopharmaceuticals announces third quarter 2016 financial results and provides corporate update . Q3 loss per share $0.39 . Q3 revenue $6.3 million versus I/B/E/S view $5.5 million .Q3 earnings per share view $-0.20 -- Thomson Reuters I/B/E/S.  Full Article

Keryx Biopharmaceuticals withdraws 2016 financial guidance
Monday, 1 Aug 2016 08:07am EDT 

Keryx Biopharmaceuticals Inc : Company withdraws its 2016 financial guidance . Company announces interruption in supply of Auryxia(ferric citrate) . Supply interruption does not affect safety profile of currently available Auryxia . Expects to make Auryxia available to patients when supply of Auryxia is back to adequate levels . Total revenues for quarter ended June 30, 2016 were about $9.3 million, compared with $2.5 million last year . Supply of Auryxia is expected to be back to adequate levels during Q4 of 2016 . Expects to file a supplemental new drug application (SNDA) with FDA late in Q3 of 2016 . Determined supply interruption is going to occur due to production-related issue in converting API to finished product at contract manufacturer . Current inventories of Auryxia are not sufficient to ensure uninterrupted patient access to this medicine . Issue resulted in variable production yields of finished drug product and company has exhausted its reserve of finished drug product . Says at this time, current inventories of Auryxia are not sufficient to ensure uninterrupted patient access to Auryxia . Says supply interruption does not affect safety profile of currently available Auryxia . Working with its existing manufacturer to resolve production-related issue and rebuild adequate supply . "We believe we are well positioned financially to manage through this interruption in supply of Auryxia".  Full Article

The Baupost Group L.L.C. reports 42.53 pct stake in Keryx Biopharmaceuticals - SEC filing
Wednesday, 1 Jun 2016 05:56pm EDT 

The Baupost Group, L.L.C. : The Baupost Group, L.L.C. reports 42.53% stake in Keryx Biopharmaceuticals Inc as of May 27, 2016 - SEC FILING .The Baupost Group, L.L.C. had earlier reported a 34.61%stake in Keryx Biopharmaceuticals Inc as of October 14, 2015.  Full Article

Keryx Biopharmaceuticals Inc announces $125 million private placement of convertible senior notes
Thursday, 15 Oct 2015 07:00am EDT 

Keryx Biopharmaceuticals Inc:Has entered into an agreement to raise $125 million through the private placement of Convertible Senior Notes due 2020, with funds managed by The Baupost Group, L.L.C.Expects to use proceeds from the financing for working capital and other general corporate purposes, including efforts to expand the utilization of Auryxia(tm) in the U.S. in the current indication and support label expansion opportunities.  Full Article

Keryx Biopharmaceuticals Inc appoints Scott A. Holmes as chief financial officer
Monday, 27 Jul 2015 08:00am EDT 

Keryx Biopharmaceuticals Inc:Says that it appoints Scott a. holmes as chief financial officer.Holmes will succeed james oliviero whose planned departure was announced earlier this year.Says oliviero will stay with the company through a transition period.  Full Article

More From Around the Web

BRIEF-Keryx says FDA accepts application to expand use of Auryxia

* Keryx biopharmaceuticals announces u.s. Fda filing acceptance of supplemental new drug application for auryxia® (ferric citrate) tablets