Ardelyx Stock Trading Halted Today; FDA Advisory Committee to Discuss XPHOZAH® (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis
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.
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
