Shares of (NASDAQ: ARDX) were up 13.2% as of 2:30 p.m. ET Wednesday after the U.S. Food and Drug Administration (FDA) approved its first-in-class chronic kidney disease drug. In a press release issued Tuesday after the market close, the biopharmaceuticals company announced the FDA has approved Xphozah (tenapanor).
Xphozah is a single tablet taken twice daily as an add-on therapy to reduce serum phosphorus in adults with chronic kidney disease on dialysis. Candidate patients will either have an inadequate response to phosphate binders or are intolerant of phosphate binder therapy. The drug now stands tall as the market's first and only phosphate absorption inhibitor.
"The approval of Xphozah is an important milestone for patients on dialysis, their families, and the nephrology care community, as it represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus," stated Ardelyx CEO Mike Raab. "It is also a significant accomplishment for everyone at Ardelyx."
Source Fool.com