Ardelyx Resubmits NDA To FDA For Xphozah

(RTTNews) - Ardelyx Inc. (ARDX) said that it resubmitted a New Drug Application or NDA to the U.S. Food and Drug Administration for the approval of Xphozah (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.

The company expects to receive goal review date in mid-May.

The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints, as well as two additional Phase 4 open-label clinical trials.

In Tuesday pre-market trade, ARDX was trading at $5.08 up $0.17 or 3.42%.

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