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Ardelyx Awaiting Next Steps From FDA To Resubmit NDA For Tenapanor For Hyperphosphatemia

Biopharmaceutical company Ardelyx, Inc. (ARDX) announced Wednesday that the company has met with the U.S. Food and Drug Administration (FDA) in a Type A meeting, but was not provided sufficient clarity on what constitutes "clinical relevance of the magnitude of treatment effect" and continues to await additional information regarding the path forward for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The company said it continues to be extremely disappointed and surprised by the lack of clarity from the FDA on the next steps to resubmit the NDA even after they have conducted the requisite registration studies, which met all primary and key secondary endpoints with no safety or other identified issues.

The company has made the extremely difficult decision to implement a restructuring plan that includes a significant reduction in operating costs and 65% of workforce to preserve cash resources and extend cash runway. It retained only the key employees needed to continue to support the regulatory process and work to achieve the goal to gain approval for tenapanor for hyperphosphatemia.

The restructuring plan is expected to be completed in December 2021. The company estimates that it will incur aggregate restructuring charges of approximately $2.3 million, which will be recorded primarily in the fourth quarter 2021, related to severance payments and other employee-related costs.

In July 2021, Ardelyx announced that it had received a complete response letter (CRL) from the FDA regarding the company's NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.

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