FDA partial clinical hold on Curis leukemia study after patient death; lymphoma study paused

CURIS INC

FDA partial clinical hold on TakeAim Leukemia Phase 1/2a (NCT04278768); no new patients enrolled.
Hold triggered by death of R/R AML patient; rhabdomyolysis identified as dose-limiting toxicity.
Current patients may continue on emavusertib at ≤300mg BID; FDA requests additional safety data.
Curis voluntarily pauses enrollment in TakeAim Lymphoma study (NCT03328078) pending hold resolution.
FDA also requests data on Recommended Phase 2 Dose determination for emavusertib.

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