Ardelyx Halted as FDA Panel Takes Another Look at Xphozah
16 November 2022 - 5:11PM
Dow Jones News
By Colin Kellaher
Trading in shares of Ardelyx Inc. is halted Wednesday ahead of a
U.S. Food and Drug Administration advisory committee meeting on the
biopharmaceutical company's appeal of the rejection of its Xphozah
drug candidate for the control of serum phosphorus in adults with
chronic kidney disease who are on dialysis.
The FDA last year turned away Ardelyx's application and called
for additional studies, which led to a restructuring at the company
that involved a 65% workforce reduction.
Ardelyx appealed the decision, and the FDA earlier this year
agreed to seek more input from experts on the clinical
meaningfulness of the phosphate-lowering effect observed in the
Phase 3 clinical program for Xphozah.
Analysts at Citi, citing FDA briefing documents release ahead of
the meeting, earlier this week said it appears the agency remains
unconvinced by the overall benefit/risk profile for the drug and
will need the committee's panelists to markedly diverge from that
assessment to alter its viewpoint.
In a research note, Citi said it expects the meeting will be
contentious, with a close/split vote the most likely outcome.
The FDA isn't bound to follow the advice of its advisory panels,
though it usually does.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 16, 2022 10:56 ET (15:56 GMT)
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