FDA Orders Halt to $JUNO Clinical Trials; Shares Set to Collapse Lower

Sympathy stocks are already getting mauled, with KITE leading the fray off by 12.5%. BLUE is down too–off by 4.55%. BLCM is another little known CAR-T competitor, off by almost 3%.

Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial. The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen.

Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested that Juno submit, as a Complete Response to the Clinical Hold: a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency yesterday. Juno will submit the requested information to the FDA this week.

CELG is a major investor in JUNO. That money has just been whisked away.

Update: JUNO reopens for trade, down 30%.

UPDATE: Juno reveals two patients died in clinical trials.

The two adult patients died last week, Juno said in a statement Thursday, after a chemotherapy drug called fludarabine was added to the treatment regimen. It was being tested in adults with relapsed or refractory B-cell acute lymphoblastic leukemia, a cancer that affects the immune system. Juno has asked the FDA to be allowed to continue the trial without using the drug.