ARDX - Ardelyx spikes amid hopes for FDA AdCom meeting on kidney disease drug

Ardelyx (NASDAQ:ARDX) has added ~43% in the pre-market Monday after the Waltham, Massachusetts-based biotech announced that the FDA plans to conduct an AdCom meeting regarding its marketing application for kidney disease drug, XPHOZAH (tenapanor). Last year, the FDA declined to approve the company’s New Drug Application (NDA) for XPHOZAH as a treatment for serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. In reaction, Ardelyx (ARDX) filed a second level of appeal of the Complete Response Letter (CRL). Issuing an interim response, the FDA’s Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), had highlighted the need for additional input on data supporting the drug. The experts include those in the Cardiovascular and Renal Drug Advisory Committee. OND plans to respond to the Ardelyx's appeal within 30 days from the completion of the AdCom meeting. With a ~91% decline, Ardelyx (ARDX) shares have well underperformed the broader market

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Ardelyx spikes amid hopes for FDA AdCom meeting on kidney disease drug