FDA Needs More Time For Ardelyx's Appeal To Rejection Of Kidney Disease Candidate

  • Ardelyx Inc ARDX shares are down after an update regarding the appeal to the Complete Response Letter (received in July 2021) for the marketing application seeking approval for Xphozah (tenapanor).
  • Peter Stein, Director of the Office of New Drugs, Center for Drug Evaluation and Research of the FDA, requested a meeting with Ardelyx to discuss the status of his review of the appeal. 
  • Dr. Stein communicated that the FDA is finalizing the response and may require up to a few more weeks to do so
  • Ardelyx will communicate the response to the appeal once it has been received from the FDA.
  • In November, Ardelyx announced positive findings from FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting concerning tenapanor. 
  • While FDA once rejected it, the panel voted for its approval as a treatment for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
  • It received a majority vote as a monotherapy and combination treatment with phosphate binder.
  • While CRDAC’s recommendations are not binding, the FDA’s Office of New Drugs (OND) was supposed to consider it when deciding on Ardelyx’s appeal for tenapanor. 
  • OND was expected to respond to the appeal within thirty days.
  • Price Action: ARDX shares are down 3.57% at $1.89 during the premarket session on the last check Friday.
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