FDA re­jects blad­der can­cer ther­a­py de­vel­oped by Patrick Soon-Sh­iong’s Im­mu­ni­ty­Bio

The FDA re­ject­ed Im­mu­ni­ty­Bio’s bi­o­log­ics li­cense ap­pli­ca­tion for a spe­cif­ic blad­der can­cer, and the biotech’s shares $IBRX tum­bled about 50% be­fore the open­ing bell Thurs­day.

Patrick Soon-Sh­iong’s Im­mu­ni­ty­Bio re­ceived the com­plete re­sponse let­ter for Ank­ti­va, or N-803, on Tues­day. The agency cit­ed de­fi­cien­cies re­lat­ed to an in­spec­tion of a third-par­ty con­tract man­u­fac­tur­er, Im­mu­ni­ty­Bio said in an SEC fil­ing, not­ing the “sat­is­fac­to­ry res­o­lu­tion of the ob­ser­va­tions” is need­ed be­fore a BLA ap­proval.

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