Ardelyx Provides Corporate Update Following Type A Meeting with FDA

FREMONT, Calif. and WALTHAM, Mass.: FREMONT, Calif. and WALTHAM, Mass., Oct. 13, 2021 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that the company has met with the U.S. Food and Drug Administration (FDA) in a Type A meeting, but was not provided sufficient clarity on what constitutes "clinical relevance of the magnitude of treatment effect" and continues to await additional information regarding the path forward for the company’s New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
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