KURA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• We are a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Since our founding in 2014, we have transformed from a research and development company to a fully-integrated commercial-stage organization with a diversified pipeline of product…

• On November 13, 2025, the U.S. Food and Drug Administration, or FDA, approved our new drug application, or NDA, for ziftomenib, which is being marketed in the United States under the trade name KOMZIFTI, for the treatment of adults with relapsed or refractory acute myeloid leukemia, or AML, with a s…

• FDA approval of our NDA for KOMZIFTI was based upon positive data from our KOMET-001 trial, a global Phase 1/2 trial that evaluated KOMZIFTI’s safety and efficacy in 112 patients with relapsed or refractory NPM1-mutated AML.

• We believe that KOMZIFTI is differentiated from other menin inhibitors based on its efficacy, safety, compatibility and simplicity, and our market research indicates that this differentiated profile aligns with the priorities of physicians, pharmacists and care teams who treat patients with AML as w…

• Efficacy: The rate of complete remission, or CR, plus CR with partial hematologic recovery, or CRh, in the KOMET-001 trial was 21.4% (95% CI: 14.2, 30.2). The median duration of CR+CRh was five months (95% CI: 1.9, 8.1) and the

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• We are a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates designed to target cancer signaling pathways where there is a strong scientific and clinical rationale t…

• Our lead product candidate is ziftomenib, a selective investigational inhibitor of the menin-KMT2A protein-protein interaction. We are developing ziftomenib for the treatment of genetically defined subsets of acute leukemias, including acute myeloid leukemia, or AML, and acute lymphoblastic leukemia…

• In addition to hematologic malignancies, we are exploring the use of ziftomenib in combination with imatinib for the treatment of gastrointestinal stromal tumors, or GIST, and ziftomenib and our next-generation menin inhibitors for use in other indications, including diabetes and other cardiometabol…

• Along with our menin inhibitor program, we are evaluating the ability of farnesyl transferase inhibitors, or FTIs, to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. Our lead FTI product candidate is darlifarnib, which we are evaluating as a monotherapy and in …

• In addition to darlifarnib, we are evaluating tipifarnib, our first-generation FTI, in combination with alpelisib, a PI3 kinase alpha, or PI3Kalpha, inhibitor, in patients with head and neck squamous cell carcinoma, or HNSCC, whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplif…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• We are not currently a party to, nor is our property the subject of, any material legal proceedings.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our results of operations or financial position.

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• Our ability to generate revenue is highly dependent on the successful commercialization of KOMZIFTI in the United States and continued global development of ziftomenib. If we are unable to successfully commercialize KOMZIFTI in the United States, or to expand ziftomenib’s indications of use or marke…

• KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

• If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.

• If we are unable to execute on our sales, marketing and distribution plans to commercialize KOMZIFTI, we may be unable to generate meaningful product revenue.

• If competitors develop products, product candidates or technologies that are superior to or more favorable than KOMZIFTI or our product candidates, such development would significantly impact the development and commercial viability of KOMZIFTI and our product candidates, which would severely and ad…

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• We are highly dependent on the success of our lead product candidate, ziftomenib, which is still in clinical development, and we cannot give any assurance that ziftomenib or any of our other product candidates will receive regulatory approval, which is necessary before they can be commercialized. Ev…

• Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to …

• If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.

• Any product candidate for which we obtain marketing approval will be subject to extensive post-approval regulatory requirements and could be subject to post-approval restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if…

• If we are unable to, or if we do not, obtain and maintain intellectual property protection for our product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, an…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• During the three months ended March 31, 2026, certain of our officers adopted, modified or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:

• 184,460, RSUs net shares to be received, and PSUs net shares to be received

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• On November 3, 2025, we announced receipt of a $30.0 million milestone payment under the Kyowa License Agreement in connection with the dosing of the first patient in the second of two KOMET-017 Phase 3 registrational trials of ziftomenib.

• During the three months ended September 30, 2025, certain of our directors and officers adopted, modified or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:

• 79,696, PSUs and RSUs net shares to be received, and ESPP net shares to be purchased

• 90,116, Options net shares unsold, RSUs net shares to be received, and ESPP net shares to be purchased