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.
Every biotech investor knows the challenge: Kura Oncology’s disclosures can bury critical details—R&D spend, ziftomenib trial milestones, and dilution risks—inside hundreds of technical pages. Missing a single update in the company’s 8-K material event could skew your valuation model.
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Kura Oncology, Inc. (KURA) filed an 8-K to disclose that, on June 27, 2025, it executed a Co-Promotion and Medical Affairs Agreement with Kyowa Kirin, Inc. covering U.S. commercialization of its oral menin inhibitor ziftomenib for acute myeloid leukemia and other hematologic malignancies. The agreement operates under the previously announced November 20, 2024 Collaboration and License Agreement.
Main commercial terms
- Co-promotion rights: Kyowa Kirin US will handle up to a specified share of sales details and must meet minimum detailing thresholds with qualified representatives.
- Cost sharing: Both companies will split all U.S. co-promotion and medical affairs expenses 50/50.
- Medical affairs leadership: Kura will lead U.S. medical affairs, with input from Kyowa Kirin; the parties will jointly craft a health economics and outcomes research strategy.
- Term & termination: The pact lasts until the earlier of (i) mutual decision to cease commercialization or (ii) expiration of the U.S. collaboration term—defined as the latest of patent expiry, regulatory exclusivity expiry, or 10 years after first commercial sale. It terminates automatically if the broader Collaboration Agreement ends, and either side may end it for an uncured material breach.
The full agreement, with confidential portions redacted, will be filed as an exhibit to Kura’s Form 10-Q for the quarter ending June 30, 2025.
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.
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