FDA allows Curis to resume enrollment in Phase 1a of emavusertib leukemia study

CURIS INC

FDA removed partial clinical hold on monotherapy dose-finding (Phase 1a) of TakeAim Leukemia study after reviewing rhabdomyolysis data.
At least nine additional patients will be enrolled at the 200 mg dose level in Phase 1a.
Partial hold remains on combination phase (Phase 1b) and expansion phase (Phase 2a) until FDA approves progression.
Rhabdomyolysis side-effect management strategy was key to FDA clearance; similar to approach used with Odomzo and Cotellic.
Preliminary clinical data update from TakeAim Leukemia study expected in 2023; company engaging FDA leukemia division on optimal dose and development path.

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