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

Rhea-AI Summary

Ardelyx, Inc. (Nasdaq: ARDX) announced that Nasdaq has halted trading of its common stock in light of ongoing discussions by the FDA's Cardiovascular and Renal Drugs Advisory Committee regarding its New Drug Application for XPHOZAH (tenapanor). This meeting, scheduled for November 16, 2022, will evaluate XPHOZAH's efficacy in managing serum phosphorus in adult patients with chronic kidney disease on dialysis. The outcome of this meeting could significantly impact Ardelyx's market position and future developments.

Positive

• Three successful Phase 3 trials completed for XPHOZAH.
• XPHOZAH addresses a significant unmet medical need in CKD patients.

Negative

• Trading halt could indicate potential regulatory concerns.
• Dependence on FDA approval for future growth.

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

FAQ

Why was Ardelyx's stock trading halted?

Ardelyx's stock trading was halted by Nasdaq due to discussions surrounding its New Drug Application for XPHOZAH at the FDA's Advisory Committee meeting.

What is XPHOZAH used for?

XPHOZAH (tenapanor) is intended for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis.

When is the FDA Advisory Committee meeting for XPHOZAH?

The FDA Advisory Committee meeting is scheduled for November 16, 2022, from 9:30 am to 5:00 pm ET.

What are the implications of the FDA meeting for ARDX stock?

The outcome of the FDA meeting will have significant implications for Ardelyx's stock performance, particularly regarding the approval of XPHOZAH.

What is the significance of the Phase 3 trials for XPHOZAH?

The successful completion of three Phase 3 trials demonstrates XPHOZAH's potential effectiveness, which is critical for regulatory approval and market success.