FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Ku­ra On­col­o­gy is clear to re­sume stud­ies for its ear­ly-stage leukemia pro­gram af­ter the FDA lift­ed a clin­i­cal hold Thurs­day af­ter­noon.

Reg­u­la­tors had placed the hold on a Phase Ib study of KO-539, an ex­per­i­men­tal oral treat­ment for some ge­net­ic sub­sets of acute myeloid leukemia last No­vem­ber af­ter a pa­tient died while tak­ing the drug. Ku­ra ex­pects to be­gin en­rolling pa­tients again im­mi­nent­ly, CEO Troy Wil­son told End­points News.

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