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.