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Juno's JCAR015 Phase II on clinical hold

July 8, 2016 1:02 AM UTC

Juno Therapeutics Inc. (NASDAQ:JUNO) fell $11.68 (29%) to $29.14 in early after-hours trading Thursday after FDA placed a clinical hold on the Phase II ROCKET trial of JCAR015 to treat relapsed or refractory acute lymphoblastic leukemia (ALL) following two patient deaths from cerebral edema. The product, Juno's most advanced program, is a chimeric antigen receptor T cell therapy targeting CD19.

Juno said a third ROCKET patient died with cerebral edema in May, but FDA and a DSMB concluded there were "confounding factors" and changes to the trial were not warranted as a result of that death. ...