ARDX - Ardelyx stock rises ~13% as kidney disease drug gets FDA panel meeting in November

Ardelyx (NASDAQ:ARDX) said a panel of the U.S. Food and Drug Administration (FDA) will meet in November to discuss an application seeking approval of its for kidney disease drug Xphozah, which was rejected by the regulator last year The FDA's Cardiovascular and Renal Drugs Advisory Committee is tentatively scheduled to meet on Nov. 16 to discuss Ardelyx's new drug application (NDA) for Xphozah (tenapanor) to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, according the company's on June 21 press release. In July 2021, the FDA had declined to approve the NDA following which the company filed an appeal of the Complete Response Letter (CRL). Ardelyx said the FDA's Office of New Drugs (OND) noted that additional input from an advisory committee, including input from experts who care for patients on dialysis, would be useful in considering the clinical meaningfulness of the phosphate lowering effect seen in the company's phase 3

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Ardelyx stock rises ~13% as kidney disease drug gets FDA panel meeting in November