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Item 8.01 Other Events.
On November 24, 2021, Kura Oncology, Inc. (the “Company”) reported that the U.S. Food and Drug Administration (the “FDA”) has placed the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (“AML”) on a partial clinical hold. The partial clinical hold was initiated following the Company’s recent report to the FDA of a Grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML. Patients currently enrolled in the Phase 1b study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved. Until the partial clinical hold is resolved, and the Company has more clarity regarding the impact on timing, the Company is suspending guidance on the completion of enrollment in the KOMET-001 Phase 1b study and determination of the recommended Phase 2 dose of KO-539.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|KURA ONCOLOGY, INC.|
|Date: November 24, 2021||By:|
|Chief Legal Officer|