Ardelyx FDA accepts XPHOZAH resubmission; PDUFA Oct 17, 2023

ARDELYX, INC.

FDA accepted resubmission of NDA for XPHOZAH (tenapanor) for serum phosphate control in dialysis patients.
FDA designated class 2 review with six-month review period; user fee goal date October 17, 2023.
Ardelyx expects XPHOZAH to be commercially available in Q4 2023 following potential FDA approval.
NDA supported by over 1,200 patients in Phase 3 trials (PHREEDOM, BLOCK, AMPLIFY) that met primary endpoints.

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