19 July 2021 -  Ardelyx today announced that it received a letter from the U.S. FDA on 13 July 2021, stating that, as part of its ong-oing review of the company's new drug application for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis, the FDA has identified deficiencies that preclude discussion of labelling and post-marketing requirements/commitments at this time. 

The letter stated that the notification does not reflect a final decision on the information under review. 

Ardelyx immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.

Read Ardelyx press release