Ardelyx (ARDX) Stock Soars 25% In Pre-Market Amid Receiving FDA Letter: Promising Stock Worth Your Money.

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).

According to the CRL, while the FDA agrees that the provided data gives substantial evidence that tenapanor is effective in decreasing serum phosphorus in CKD patients on dialysis, they describe the magnitude of the treatment effect as small and of unclear clinical essence. Also, the FDA told that for the application to be approved, Ardelyx needs to conduct an additional proper and well-contained trial showing a clinically needed treatment result on serum phosphorus or an effect on the clinical result thought to be because of hyperphosphatemia in CKD patients on dialysis.

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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.

Richard McEntire

Finance and Entertainment ReporterRichard is a bottle of wine - the older the sweeter. He has already found the sweetest hobby in writing entertainment and finance news for Own Snap. Readers get the updated posts regularly from him searching for real-time news.