July 7, 2016 6:37pm
Stock dropped -27.36% or $11.17 to $29.65 after closing at $40.82 (+$0.88)
Both deaths occurred last week after the patients, who had relapsed or refractory B cell acute lymphoblastic leukemia, took the drug fludarabine before receiving the chimeric antigen receptor (CAR) T cells that Juno had taken from their bodies and re-engineered to better attack cancer cells.
The drug, known as JCAR15, was being supplied to patients suffering from acute lymphoblastic leukemia; the deaths occurred after fludarabine was added to the pre-conditioning regimen.
The patients died from neurotoxicity-related complications; neurotoxicity is a known side effect of the type of therapy JUNO was testing.
Fludarabine is common in chemotherapies for blood cancers, and Juno recently decided to add it to the cyclophosphamide regimen it had been using for preconditioning.
Juno has proposed to the FDA to drop the fludarabine from the regimen. The FDA asked Juno to submit, a “Complete Response to the Clinical Hold”: a revised patient informed consent form and a revised investigator brochure
The Bottom Line: JUNO’s leukemia trial had been put on clinical hold after two patients died, sending shares -27.36% lower in after-hours action. Trading on Juno stock was halted after hours but later resumed. The news hit Kite Pharma (KITE -$5.40 or -10.36%), Bellicum Pharma (BLCM -$0.71 or -4.83%) and bluebird bio (BLUE -$2.43 or -4.98%) whose pipeline is less dependent on CAR-T.
