Approval at last: Ardelyx puts regulatory hitches to rest in US with long-sought CKD nod
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
Piper Sandler Ardelyx Inc Chronic Kidney Disease Ardelyx Inc Phosphate Absorption Binder Phosphate Binder
Source: bioworld.com