WALTHAM,
Mass., Nov. 16, 2022 /PRNewswire/ -- Ardelyx,
Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a
mission to discover, develop and commercialize innovative
first-in-class medicines that meet significant unmet medical needs,
today announced that Nasdaq has halted trading of the Company's
common stock.
The U.S. Food and Drug Administration's (FDA) Cardiovascular and
Renal Drugs Advisory Committee (CRDAC) is meeting to discuss the
company's New Drug Application (NDA) for XPHOZAH (tenapanor) for
the control of serum phosphorus in adult patients with chronic
kidney disease (CKD) on dialysis.
The Advisory Committee meeting is scheduled for Wednesday, November 16, from 9:30 am to 5:00 pm ET. The briefing materials can
be found on the FDA website at:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-16-2022-meeting-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement#event-materials.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx's first approved product,
IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing
XPHOZAH® (tenapanor), a novel product candidate to
control serum phosphorus in adult patients with CKD on dialysis,
which has completed three successful Phase 3 trials. Ardelyx has a
Phase 2 potassium lowering compound, RDX013, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun
Pharma in China and Knight
Therapeutics in Canada for the
development and commercialization of tenapanor in their respective
territories. For more information, please visit
https://ardelyx.com/ and connect with us on Twitter @Ardelyx,
LinkedIn and Facebook.
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SOURCE Ardelyx