See Why FDA Hit Red Light On Kura's Early-Stage Leukemia Trial

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

• Kura reported that the Phase 1b study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probe the death.
• Patients already on the drug can continue taking it.
• According to Kura, the death was “potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.”
• Until the partial clinical hold is resolved, Kura is suspending guidance on completing enrollment in the KOMET-001 Phase 1b study and determining the recommended Phase 2 dose of KO-539.
• Earlier, the Company expected to complete enrollment in Q1 of 2022.
• The oral drug is designed to block the interaction of two proteins - menin and KMT2A/MLL. 
• Related content: Benzinga's Full FDA Calendar.
• Price Action: KURA shares fell 16.9% at $13.81 during the market session on the last check Wednesday.