- The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Ardelyx Inc's ARDX tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
- The agency asked the company to submit additional analyses to help the FDA better understand the clinical data in light of tenapanor's novel mechanism of action as compared to approved therapies.
- In response, the company submitted the requested analyses, resulting in an extension of the PDUFA date by three months to July 29, 2021.
- Price Action: ARDX shares drop 19% at $6.83 in the premarket session on the last check Friday.
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