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Juno's mid-stage study of lead CAR-T candidate on clinical hold after two deaths; shares plummet 31% after hours

Jul. 07, 2016 4:32 PM ETJuno Therapeutics (JUNO) StockKITE, JUNOBy: Douglas W. House, SA News Editor51 Comments
  • Juno Therapeutics' (NASDAQ:JUNO) Phase 2 clinical trial, ROCKET, assessing lead CAR-T candidate JCAR015 in adult patients with relapsed/refractory B cell acute lymphoblastic leukemia (r/r ALL) has been placed on clinical hold by the FDA after two study participants died last week following the recent addition of chemo agent fludarabine to the pre-conditioning regimen.
  • The company has proposed continuing the study using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested a revised patient informed consent form, a revised investigator brochure, a revised study protocol and a copy of the presentation made to the agency yesterday. Juno intends to submit the information next week.
  • Clinical hold means that the investigational drug cannot be given to study participants and no new subjects can be recruited.
  • The action does not affect Juno's development programs for other CD19-directed CAR-T candidates, including JCAR017.
  • Shares are off 1% after hours on light volume.
  • Update: Shares are now down 31% on robust volume. In sympathy, Kite Pharma (NASDAQ:KITE) is down 13% after hours on robust volume.

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