FDA lifts hold on Curis' emavusertib in TakeAim leukemia study

US biotech Curis (Nasdaq: CRIS) saw its shares close down almost 10% at $1.01 yesterday, despite its announcement that the US Food and Drug Administration (FDA) has notified the company that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study of emavusertib.

Previously, Curis announced that the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April 2022. On August 18, 2022, Curis reported that the partial clinical hold on the TakeAim Lymphoma study was lifted.

After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase Ia) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. The partial hold remains in place for the combination therapy phase (Phase Ib) and the expansion phase (Phase IIa) of the study until Phase Ia is complete and the FDA approves proceeding to the next phases of the study.