Juno’s lead CAR-T slammed with a clin­i­cal hold in the last lap ahead of FDA fil­ing

One of Juno’s crit­i­cal stud­ies for its lead CAR-T ther­a­py has just been in­def­i­nite­ly side­lined fol­low­ing the un­ex­plained death of two pa­tients from neu­ro­tox­i­c­i­ty, de­rail­ing the com­pa­ny’s plans to seek mar­ket­ing ap­proval in time for a 2017 launch.

In a nasty sur­prise for share­hold­ers, Juno an­nounced Thurs­day af­ter­noon that the FDA had placed a clin­i­cal hold on its ROCK­ET study, a Phase II clin­i­cal tri­al of JCAR015 in adult pa­tients with re­lapsed or re­frac­to­ry B cell acute lym­phoblas­tic leukemia. That hob­bles the com­pa­ny just as it en­tered the last lap in a tight race with Kite Phar­ma.

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