Ardelyx Shares Rally Premarket on FDA Approval of Xphozah

By Colin Kellaher

Shares of Ardelyx rose sharply in premarket trading Wednesday after the biopharmaceutical company finally won U.S. Food and Drug Administration approval of its Xphozah drug for kidney disease.

After the closing bell on Tuesday, the Waltham, Mass., biopharmaceutical company said the FDA approved Xphozah to reduce serum phosphorus in adults with chronic kidney disease who are on dialysis.

The FDA in 2021 rejected Ardelyx's initial application for approval of Xphozah, but the company appealed, and an FDA advisory committee late last year voted that the drug's benefits outweigh its risks, and the agency in May accepted Ardelyx's resubmitted application for Xphozah.

Ardelyx said the commercial launch for Xphozah is underway, with the drug expected to be available next month.

Ardelyx shares, which closed Tuesday at $3.45, were recently up more than 16% to $4.02 in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-18-23 0815ET