{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-280255","form_type":"8-K","ticker":"KURA","cik":"0001422143","company_name":"Kura Oncology, Inc.","filed_at":"2025-11-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.374188+00:00","generated_at":"2026-05-16T20:18:27.016704+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Kura Oncology announces FDA full approval of KOMZIFTI for NPM1-mutated AML","bullets":["FDA granted full approval of KOMZIFTI (ziftomenib) on November 13, 2025 for R/R NPM1-mutated AML patients with no satisfactory alternative.","KOMZIFTI is the first and only once-daily oral menin inhibitor approved for this indication, with a CR+CRh rate of 21.4% in the KOMET-001 trial.","Median duration of CR+CRh was 5.0 months; median time to first response was 2.7 months; 88% of responders achieved remission within 6 months.","Kura Oncology set a wholesale acquisition cost of $48,500 per month; global collaboration with Kyowa Kirin oversees U.S. and ex-U.S. commercialization.","Boxed Warning for differentiation syndrome included; no Grade 4 or 5 QTc prolongation reported in the pivotal study."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-280255","json":"https://secwatch.observer/filing/0001193125-25-280255.json","markdown":"https://secwatch.observer/filing/0001193125-25-280255.md","text":"https://secwatch.observer/filing/0001193125-25-280255.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/0001193125-25-280255-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/d159173d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-16T20:18:27.016704+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}