FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clin­i­cal hold on the ear­ly-stage pro­gram for one of Ku­ra On­col­o­gy’s can­cer drugs fol­low­ing a pa­tient’s death in a clin­i­cal tri­al.

The biotech $KU­RA re­port­ed ear­ly Wednes­day that the Phase Ib study of KO-539 for acute myeloid leukemia would be halt­ed, sus­pend­ing en­roll­ment, while re­searchers and the FDA probed the death. Pa­tients al­ready on the drug can con­tin­ue tak­ing it.

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