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LONDON, UK / ACCESSWIRE / March 9, 2017 / Active Wall St. blog coverage looks at the headline from Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) as the Company announced on March 08, 2017, that the US Food and Drug Administration (FDA) have accepted for review the supplemental New Drug Application (sNDA) for Auryxia® (ferric citrate) tablets. Register with us now for your free membership and blog access at:

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One of Keryx Biopharma's competitors within the Biotechnology space, Portola Pharmaceuticals, Inc. (NASDAQ: PTLA), provided a corporate update and reported its financial results for Q4 and year ended December 31, 2016, on February 28, 2017. AWS will be initiating a research report on Portola Pharma in the coming days.

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Keryx stated that the sNDA acceptance by the FDA indicates that the application is sufficiently complete to permit a substantive review. As per the Prescription Drug User Fee Act (PDUFA), target action date for completion of the FDA's review is November 06, 2017.

About Auryxia

Auryxia (ferric citrate) was approved by the US FDA on September 05, 2014 and is indicated in the US for the control of serum phosphorus levels in patients with CKD on dialysis. Each Auryxia tablet contains 210 mg of ferric iron, equivalent to 1 g of ferric citrate. Keryx, with this sNDA submission, is seeking to expand the indication for Auryxia to include the treatment of iron deficiency anemia (IDA) in patients with non-dialysis dependent chronic kidney disease (NDD-CKD).

The US approval of Auryxia was based on data from the Company's Phase-3 registration program in dialysis patients. In the Phase-3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.

"Iron deficiency anemia is a common complication in people with non-dialysis dependent chronic kidney disease, yet currently there are no FDA-approved oral medicines to treat this debilitating disease," said John Neylan, M.D., Senior Vice President and Chief Medical Officer of Keryx Biopharmaceuticals, "Acceptance of the sNDA filing not only brings us one step closer to providing this medicine to patients in need; it is an important milestone for the Company and our efforts to leverage ferric citrate's mechanism of action."

The Phase-III trial Study

Keryx's recent sNDA was based on data from a 24-week placebo controlled Phase-3 trial in 234 adults with stage 3-5 NDD-CKD. Patients enrolled in the trial had haemoglobin levels between 9.0 g/dL and 11.5 g/dL and were intolerant to or had an inadequate response to prior treatment with oral iron supplements. The starting dose in the study was three tablets per day taken with meals. Importantly, during the study, patients were not allowed to receive any IV or oral iron, or ESAs. In the study, treatment with Auryxia demonstrated significant increases in haemoglobin levels of >1 g/dL at any point during the 16-week efficacy period for the majority of patients, a clinically meaningful result. In the trial, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event.

About Iron Deficiency Anemia, NDD-CKD

Keryx estimates that of the 1.7 million Americans with NDD-CKD under the care of a nephrologist, approximately 650,000 are treated for IDA and another 250,000 ? 400,000 could have IDA but are not treated today. According to market research, nephrologist's report that the majority of their patients are sub-optimally treated with currently available oral iron supplements and that a need exists for a new treatment option for their patients with iron deficiency anemia and NDD-CKD.

Stock Performance

At the close of trading session on Wednesday, March 08, 2017, Keryx Biopharma's stock price rose 1.38% to end the day at $5.15. A total volume of 1.55 million shares were exchanged during the session, which was above the 3-month average volume of 1.41 million shares. The Company's share price has gained 22.62% in the past six months. The stock currently has a market cap of $542.35 million.

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