Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments
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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Plus deals involving Shionogi/NEC, Ji Xing/LENZ, Kyowa Kirin/Ardelyx, CR Pharma/Everest Medicine and Dr Reddy’s/Novartis.
GentiBio closed a $157m series A venture capital round, while clinical trial innovator Reify Health raised a $220m series C and Neurelis secured $150m. Also, IPOs slowed in August, but Adagio and Eliem grossed $309.4m and $80m, respectively, and RNA firm Greenlight will go public in a $282m SPAC deal.
Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.