Keryx Biopharmaceuticals (KERX) Announces FDA Approval of Auryxia Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis; Shares Tumble


Keryx Biopharmaceuticals (NASDAQ:KERX) announced that the FDA has approved Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD), not on dialysis. Auryxia was originally approved in September 2014 for the control of serum phosphorus levels in people with chronic kidney disease who require dialysis.

With the new indication, millions of people living with chronic kidney disease have the potential to benefit from treatment with Auryxia. This medication is available today in pharmacies and covered broadly by Medicare Part D and commercial insurance providers in the United States.

“More than half of the approximate 30 million people in the United States living with chronic kidney disease are iron deficient, and yet, this is the only tablet that has been developed and approved specifically to address iron deficiency anemia in these patients, who are not on dialysis,” said Steven Fishbane, M.D., chief, division of kidney diseases and hypertension, department of medicine, Northwell Health in Great Neck, New York. “Starting today, physicians can prescribe an oral iron medicine to help people living with this condition, the majority of whom are not being optimally treated.”

“We are pleased with the broad indication permitted by the FDA, as a first-line treatment option for adults with iron deficiency anemia and chronic kidney disease, not on dialysis,” said John Neylan, M.D., senior vice president and chief medical officer of Keryx Biopharmaceuticals. “Physicians and their patients now have a new treatment option to help manage a serious complication of this complex disease.”

In the wake of the FDA approval, Keryx shares are falling nearly 12% to $5.50. KERX has a 1-year high of $8.38 and a 1-year low of $4.47. The stock’s 50-day moving average is $6.75 and its 200-day moving average is $6.80.

On the ratings front, KERX stock has been the subject of a number of recent research reports. In a report issued on September 12, Raymond James analyst Reni Benjamin maintained a Buy rating on KERX, with a price target of $9, which implies an upside of 44% from current levels. Similarly, on July 27, Maxim’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $9.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Reni Benjamin and Jason Kolbert have a yearly average loss of -7.0% and -8.7% respectively. Benjamin has a success rate of 39% and is ranked #4548 out of 4703 analysts, while Kolbert has a success rate of 35% and is ranked #4640.

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.