Ardelyx Shares Rally Premarket on FDA Approval of Xphozah
18 Octubre 2023 - 7:30AM
Noticias Dow Jones
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 18, 2023 08:15 ET (12:15 GMT)
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