ARDX Ardelyx Inc

By Michael Dabaie

Ardelyx Inc. shares dropped 74% to $1.97 after the company said it received a letter from the FDA on its application for tenapanor in chronic kidney disease.

The biopharmaceutical company after the bell Monday said it received a letter from the U.S. Food and Drug Administration stating that, as part of its review of the tenapanor new drug application for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis, the FDA identified deficiencies that "preclude discussion of labeling and post-marketing requirements/commitments at this time."

The letter stated that the notification doesn't reflect a final decision on the information under review.

Ardelyx said it requested a meeting to discuss the deficiencies and was notified by the FDA Monday that the request was denied.

The FDA hasn't provided specific details regarding the deficiencies, but noted a key issue is the size of the treatment effect and its clinical relevance, Ardelyx said.

Wedbush downgraded the stock to Neutral from Outperform and lowered the price target to $3.00 from $14.00.

"With regulators indicating size of the treatment effect and its clinical benefit as a key issue, we are hard pressed to see anything but a Complete Response Letter emerging for tenapanor. The move is unexpected particularly in light of earlier labeling discussions between ARDX and FDA," Wedbush said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

July 20, 2021 11:53 ET (15:53 GMT)

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