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Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments

Executive Summary

While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

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Ardelyx Plans Mid-2020 NDA Filing For Tenapanor In Hyperphosphatemia

The company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.

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