In a stun­ner, FDA im­me­di­ate­ly drops its hold on Juno’s lead CAR-T

So much for bu­reau­cra­cy. In what may well be the short­est high-pro­file FDA clin­i­cal hold in the agency’s his­to­ry, Juno re­port­ed to­day that the FDA has lift­ed the halt on its lead CAR-T pro­gram, sat­is­fied that it found the cause for three pa­tient deaths.

Juno’s bat­tered shares $JUNO im­me­di­ate­ly rock­et­ed back up 28%.

Juno con­found­ed in­vestors last week when it re­port­ed the deaths and the sur­pris­ing hold, cit­ing the re­cent ad­di­tion of the chemother­a­py agent flu­dara­bine to its pre­con­di­tion­ing of pa­tients as a like­ly cul­prit. Some ex­perts, who had used the drug in oth­er stud­ies to help clear the path for a fol­lowup ther­a­py, pub­licly ques­tioned the ra­tio­nale. But the agency had no prob­lem pro­vid­ing a quick green light to re­sume the piv­otal study.

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