Ardelyx Shares Lower Premarket on Delay in FDA Xphozah Appeal

By Colin Kellaher

Shares of Ardelyx Inc. slipped in premarket trading Monday after the biopharmaceutical company reported a delay in the decision on its appeal of the U.S. Food and Drug Administration's rejection of its Xphozah drug candidate.

Ardelyx, which had expected a decision around mid-December, late Friday said it was advised that the FDA is finalizing its response to the appeal and may need up to a few more weeks to do so.

The FDA last year turned away Ardelyx's application seeking approval of Xphozah for the control of serum phosphorus in adults with chronic kidney disease who are on dialysis.

Ardelyx appealed the decision, and the FDA agreed to seek more input from an advisory committee, which in mid-November voted that the benefits of Xphozah outweigh its risks.

Ardelyx at the time said it expected a response within 30 days from the FDA's Office of New Drugs, which was considering the appeal.

The FDA isn't bound to follow the advice of its advisory panels, though it usually does.

Ardelyx shares, which closed Monday at $1.96, were recently down 5.6% at $1.85 in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

December 19, 2022 08:05 ET (13:05 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.