Ardelyx sinks as FDA identifies deficiencies in NDA

 Ardelyx, Inc. (Nasdaq: ARDX) 69% LOWER; received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling 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. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.

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