Ardelyx receives FDA appeal grant for XPHOZAH; plans NDA resubmission in H1 2023

ARDELYX, INC.

On Dec 27, 2022, FDA OND granted appeal of July 2021 CRL for XPHOZAH (tenapanor) after Nov 16 CRDAC favorable vote.
OND directs Division of Cardiology and Nephrology to work with Ardelyx on label development for hyperphosphatemia insufficiently managed on binder therapy.
Company expects to resubmit NDA in H1 2023; review classification (Class 1: 2 months, Class 2: 6 months) to be determined post-resubmission.
This reverses prior complete response letter and represents a major regulatory milestone for Ardelyx's only late-stage candidate.

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