Despite going up by over 63 percent in the last 12 months, Keryx Biopharmaceuticals (NASDAQ:KERX) has further upside based on the upcoming FDA ruling on its supplemental NDA (sNDA) for its lead drug Auryxia. A positive decision will help the company in expanding the addressable market for the drug by including non-dialysis patients under its ambit. Apart from this short term catalyst, the stock is also expected to benefit from ongoing efforts for label expansion for Auryxia. Auryxia is now accessible by 95 percent of dialysis patients on phosphate binders with commercial or Medicare Part D insurance. Keryx Biopharmaceuticals is further looking to expand the drug label to treat iron deficiency in non-dialysis-dependent chronic kidney disease, expanding its market reach.
Earlier this year, the company announced FDA review approval for the sNDA related to Auryxia tablets. For the iron-deficiency sNDA, the FDA is expected to announce its decision in November. It is likely to be a major catalyst for the stock as currently there is no FDA approved oral treatment to treat iron deficiency in non-dialysis-dependent chronic kidney disease (NDD-CKD) and the company stands a strong chance to become the first mover in the market. Auryxia was first approved in 2014 for the control of serum phosphorous levels in patients with chronic kidney disease (CKD) on dialysis.