Welcome to our dedicated page for Kura Oncology SEC filings (Ticker: KURA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Kura Oncology, Inc. (Nasdaq: KURA) SEC filings page on Stock Titan provides direct access to the company’s regulatory disclosures, including current reports, financial updates and material agreements. As a biopharmaceutical company focused on precision medicines for cancer, Kura uses these filings to report significant events related to its lead menin inhibitor program, KOMZIFTI (ziftomenib), and its broader pipeline.
Recent Form 8-K filings describe key milestones such as full U.S. Food and Drug Administration approval of KOMZIFTI for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation, clinical data from the pivotal KOMET-001 trial, and the wholesale acquisition cost for a one-month supply of KOMZIFTI. Other 8-Ks outline collaboration and co-promotion agreements with Kyowa Kirin, including terms under which Kura leads development, regulatory and commercial strategy in the United States while Kyowa Kirin leads efforts outside the United States.
Filings also cover financial results releases under Item 2.02, inducement equity plans and amendments, and milestone payments associated with the KOMET-017 Phase 3 registrational trials. These documents provide insight into Kura’s commercialization of KOMZIFTI, its clinical development plans for ziftomenib in newly diagnosed and relapsed or refractory AML, and its farnesyl transferase inhibitor programs.
On Stock Titan, investors can review KURA’s SEC filings alongside AI-powered summaries that highlight the main points of each document. This includes quick views of material events, collaboration structures, and key clinical or regulatory disclosures, helping users navigate detailed 8-Ks and related exhibits without reading every line.
Kura Oncology (KURA) filed an 8-K announcing updated Phase 1a/1b results for ziftomenib, its oral menin inhibitor, from the KOMET-007 study in newly diagnosed AML patients with NPM1-m or KMT2A-r mutations. The 600 mg QD dose given with standard 7+3 chemotherapy produced robust composite complete remission (CRc) of 92 % (65/71) and complete remission (CR) of 80 % (57/71), with similar efficacy across both genetic sub-groups (CRc: 93 % NPM1-m, 89 % KMT2A-r). MRD-negative CR rates reached 71 % for NPM1-m and 88 % for KMT2A-r, achieved in roughly 4–5 weeks.
Durability signals are emerging: median CR duration and overall survival have not yet been reached in NPM1-m patients after a median 24.9-week follow-up; KMT2A-r patients show a median CR duration of 25.6 weeks with OS not reached. Survival remains high, with 96 % (NPM1-m) and 88 % (KMT2A-r) alive and on study.
The pooled safety set (n = 82) showed a profile consistent with prior data. ≥Grade 3 treatment-related adverse events >10 % included febrile neutropenia (15 %), thrombocytopenia (15 %), anemia (11 %) and neutropenia (11 %). Importantly, there were no dose-limiting toxicities, meaningful QTc prolongation, drug–drug interactions or additive myelosuppression; a single grade-3 differentiation syndrome case was successfully managed.
Kura plans to initiate the KOMET-017 randomized Phase 3 trials (intensive and non-intensive chemo backbones) in 2H 2025. The company also hosted a virtual investor event on 18 Jun 2025 (Exhibit 99.1) to discuss the data.