Ardelyx, Inc.

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CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067
info@portnoylaw.com

Ardelyx issued a press release on July 19, 2021 “announc[ing] that it 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 chronic kidney disease patients on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”  Ardelyx stated further that “[w]hile the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance.” 

On July 20, 2021, Ardelyx’s stock price fell $5.69 per share, or 73.9%, on this news, to close at $2.01 per share.