Company Update (NASDAQ:KERX): Keryx Biopharmaceuticals Announces Publication of Auryxia Phase 3 Trial Results in JASN


Keryx Biopharmaceuticals (NASDAQ:KERX) announced the publication of results from its pivotal Phase 3 study evaluating ferric citrate for iron deficiency anemia (IDA) in non-dialysis-dependent chronic kidney disease (NDD-CKD) in the online issue of the Journal of the American Society of Nephrology (JASN).

Ferric citrate (Auryxia®) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis. Data in the publication highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD.

The article titled, “Effects of Ferric Citrate in Patients with Non-Dialysis-Dependent CKD and Iron Deficiency Anemia,” describes previously reported Phase 3 results, in which ferric citrate achieved statistically significant results on the primary and all five pre-specified secondary endpoints for the treatment of IDA in adults with NDD-CKD versus placebo. Patients enrolled in the trial had not adequately responded to or could not tolerate prior treatment with oral iron. In the Phase 3 study, 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.

“The results shown in this pivotal study demonstrated that ferric citrate, if approved for this indication, could provide an important new treatment option for people living with chronic kidney disease and iron deficiency anemia who are not on dialysis,” said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center. “Not only did ferric citrate deliver a clinically meaningful 1 g/dL increase in hemoglobin levels for the majority (52.1 percent (61/117)) of patients treated in the Phase 3 study at any point during the 16-week efficacy period, increases were seen as early as one to two weeks after start of treatment, and were sustained for the majority of patients who achieved the primary endpoint.”

“Clinical trials are critical to the advancement of safe and effective medicines, and we thank the patients, their families and the renal care teams who have participated in clinical trials for ferric citrate,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “We are pleased to have these data highlighted by a major nephrology journal, which can provide broad access for nephrologists to the Phase 3 results. We recently submitted a supplemental new drug application with these data to the U.S. FDA. If approved for this expanded indication, ferric citrate would be the first oral medicine approved by the FDA for the treatment of iron deficiency anemia in patients with NDD-CKD.”

Shares of Keryx Biopharmaceuticals are currently trading at $6.15, down $0.25 or -3.91%. KERX has a 1-year high of $7.80 and a 1-year low of $2.80. The stock’s 50-day moving average is $5.93 and its 200-day moving average is $5.49.

On the ratings front, KERX has been the subject of a number of recent research reports. In a report released yesterday, Citigroup analyst Yigal Nochomovitz upgraded KERX to Hold, with a price target of $6.50, which represents a slight upside potential from current levels. Separately, on January 9, J.P. Morgan’s Whitney Ijem reiterated a Hold rating on the stock and has a price target of $5.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yigal Nochomovitz and Whitney Ijem have a yearly average loss of -3.5% and -9.3% respectively. Nochomovitz has a success rate of 47% and is ranked #3756 out of 4340 analysts, while Ijem has a success rate of 40% and is ranked #3729.

Keryx Biopharmaceuticals, Inc. engages in the development and commercialization of medicines for the treatment of renal disease. Its products include phosphate-binding medicines, intravenous iron, and other medications.