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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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.
The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Public Company Edition: The last biopharma initial public offering in the US was on 11 November, but follow-on and other offerings are generating hundreds of millions of dollars. Among RNA drug developers, Ionis issued more than $500m in new debt, while Arrowhead raised $266.8m.