Ardelyx, Inc.


On July 19, 2021, Ardelyx announced that it had received a letter from the U.S. Food and Drug Administration on July 13, 2021 regarding the FDA’s review of Ardelyx’s New Drug Application (“NDA”) for Tenapanor for the control of serum phosphorus in patients on dialysis for chronic kidney disease. In the letter, the FDA identified deficiencies that “preclude discussion of labeling and post-marketing requirements/commitments at this time”. The FDA denied Ardelyx’s request for a meeting to discuss the deficiencies. Analysts redacted negatively, with Piper Sandler and Wedbush downgrading ARDX and lowering their price targets. A Piper Sandler analyst commented: “We struggle to see a path forward for Tenapanor.”

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