Ardelyx Shares Soar Premarket After FDA Panel Back Xphozah
17 November 2022 - 12:48PM
Dow Jones News
By Colin Kellaher
Shares of Ardelyx Inc. surged in premarket trading Thursday
after a U.S. Food and Drug Administration advisory committee voted
that the benefits of its proposed Xphozah drug for patients with
chronic kidney disease outweigh its risks.
The Fremont, Calif., biopharmaceutical company said the
committee voted 9-4 in favor of Xphozah as a monotherapy for the
control of serum phosphorus in adults with chronic kidney disease
who are on dialysis and 10-2 in favor of the drug in combination
with phosphate binders.
The FDA had convened the meeting in response to Ardelyx's appeal
of the agency's rejection of the drug last year.
Ardelyx said the FDA's Office of New Drugs, which was
considering the company's second-level appeal, will consider the
panel's vote when making its decision, with a response expected
within 30 days.
The FDA isn't bound to follow the advice of its advisory panels,
though it usually does.
Trading in Ardelyx stock was halted all day Wednesday ahead of
the meeting. The shares, which ended Tuesday's session at $1.22,
were recently up 77% to $2.16 in premarket trading Thursday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 17, 2022 06:33 ET (11:33 GMT)
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