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. 

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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.

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.