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Biotech Stocks Facing FDA Decision In April 2021

Ardelyx
Ardelyx

Ardelyx Inc.’s (ARDX) lead product candidate Tenapanor awaits the FDA decision on April 29, 2021.

Tenapanor is proposed for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis.

Hyperphosphatemia, which refers to an elevated level of phosphate in the blood, is a nearly universal condition in more than 550,000 Americans with chronic kidney disease (CKD) on dialysis, and a major risk factor for Cardiorenal morbidity and mortality.

A number of phosphate binders like Renagel, Velphoro, Auryxia, and Phoslyra, to name a few are prescribed to treat hyperphosphatemia. However, Tenapanor is a non-binder and a phosphate absorption inhibitor.

If approved, Tenapanor could record peak sales of $500 million to $700 million in the U.S.

ARDX closed Friday’s (Mar.26, 2021) trading at $6.25, up 1.63%.