Positive FDA AdCom votes for Ardelyx' tenapanor

17 November 2022

The unexpected news of a positive Food and Drug Administration advisory committee vote yesterday sent US cardiorenal-focussed drugmaker Ardelyx’ (Nasdaq: ARDX) shares surging 84.4% to $2.25 in pre-market trading this morning.

Ardelyx announced that the US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for Xphozah (tenapanor) resulted in a positive vote to recommend the drug for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The FDA advisory panel voted 9-4 that the benefits of Xphozah, when given as monotherapy, outweigh its risks in treating hyperphosphatemia in adults with chronic kidney disease (CDK) on dialysis. Committee members also voted 10-2, with one abstention, that the benefits of Xphozah outweigh its risks for the same use when administered in combination with phosphate binder treatment.

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