Ardelyx Shares Lower Premarket on Delay in FDA Xphozah Appeal
20 December 2022 - 12:20AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 19, 2022 08:05 ET (13:05 GMT)
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