Juno shares dive as clinical test halted after 2 deaths

Shares of Juno Therapeutics plunged Friday after regulators suspended a clinical trial of a leukemia treatment following two patient deaths last week.
The two patient deaths occurred after Juno recently added fludarabine to its chemotherapy regime that accompanies its cell treatment for acute lympoblastic leukemia.
Juno, in a statement released after markets closed Thursday, said it had been notified by the Food and Drug Administration (FDA) that its tests, called the "Rocket" trial, were suspended following the two deaths.
There were no treatment-related deaths when fludarabine was not included, the Seattle-based company said, adding that it would petition regulators to resume the tests.

Juno chief executive Hans Bishop said he was encouraged by other results for the treatment, Chimeric Antigen Receptor (CAR), which involves the genetic engineering of T cells, a subtype of white blood cells linked to immunity, to kill cancer cells.
However, the FDA hold "will likely impact" Juno's goal of winning approval for the treatment as early as 2017, he said.

Shares of Juno plummeted 32.1 per cent to USD 27.71 in midday trade.
The patient deaths were due to cerebral edema, a swelling of the brain caused by excessive fluids. Bishop said there may have been more than one factor behind the fatalities, but the addition of fludarabine was "most likely" responsible.

A third death in the Rocket trial in May had not prompted a shift in the trial because Juno and the FDA concluded there were other factors involved, he said.
Juno must submit four items to win approval to resume the trial without fludarabine, including a revised informed consent form. Executives said the agency has up to 30 days to review the case, but hope the request will be expedited.
"The news is a clear reminder that CAR-T is a potent therapeutic, which also comes with significant toxicity," said a note from Morgan Stanley.
Morgan Stanley predicted Juno shares would "stay depressed until management can offer greater clarity going forward.