Just yesterday, Ardelyx’s stock closed at $1.71. Nevertheless, today, it is skyrocketing: it is currently at $2.14 in the pre-market, resulting in a sensational 25% gain. The company today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD).
The FDA indicated it is ready to meet with Ardelyx to discuss ways for gaining approval. The company plans to request a Type A meeting as soon as possible to discuss the CRL and find potential ways forward for the approval of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
Finance and Entertainment Reporter
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