Deaths de­rail Juno's launch count­down, giv­ing Kite and No­var­tis the lead

The FDA’s hold on Juno Ther­a­peu­tics’ lead CAR-T pro­gram, JCAR015, last­ed on­ly six days. But the de­rail­ment was se­ri­ous enough to push its ex­pect­ed ap­proval date from 2017 back in­to 2018, leav­ing Kite Phar­ma and No­var­tis an­gling for the first ap­provals in the field in 2017.

“Re­gard­ing the ROCK­ET tri­al,” Juno CEO Hans Bish­op told an­a­lysts Thurs­day evening, “the process of get­ting IRB ap­proval across mul­ti­ple sites along with the gat­ed en­roll­ment for the next six pa­tients leaves us to now es­ti­mat­ing ap­proval as ear­ly as the first half of 2018.”

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