Juno Therapeutics Inc. (NASDAQ: JUNO) saw its shares hit a new 52-week low in Wednesday’s session after the company announced a clinical hold on its JCAR015 trial. The company announced that it has voluntarily placed on hold the Phase 2 clinical trial in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, known as the “ROCKET” trial.
The clinical hold was initiated after two patients suffered cerebral edema earlier this week. One patient died and, as of last night, the other is not expected to recover.
Juno has notified the U.S. Food & Drug Administration (FDA) of the voluntary hold and is working with the agency and the Data and Safety Monitoring Board to determine next steps.
Currently, the company is assessing data from the cases and the trial, as well as evaluating its options regarding the JCAR015 program.
For some background, Juno is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. The company is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer.
Excluding Wednesday’s move, Juno has vastly underperformed the broad markets with the stock down 32% year to date. Over the past 52-weeks the stock is actually down 45%.
Shares of Juno were last trading down over 26% at $22.00, with a consensus analyst price target of $44.27 and a 52-week trading range of $19.41 to $57.82.