{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-133717","form_type":"8-K","ticker":"KURA","cik":"0001422143","company_name":"Kura Oncology, Inc.","filed_at":"2025-06-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.248844+00:00","generated_at":"2026-05-20T01:16:47.803164+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Kura Oncology's NDA for ziftomenib accepted with Priority Review; Phase 2 shows 23% CR/CRh rate","bullets":["FDA accepted NDA for ziftomenib in R/R NPM1-m AML; Priority Review set; PDUFA date Nov 30, 2025.","Phase 2 KOMET-001: 23% (21/92) CR/CRh rate; median OS 16.4 months for responders, 3.5 months for non-responders.","63% of evaluable CR/CRh patients achieved MRD-negative; TRAEs led to discontinuation in 3% of patients.","Ziftomenib previously received Breakthrough Therapy, Fast Track, and Orphan Drug designations; co-developed with Kyowa Kirin."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-133717","json":"https://secwatch.observer/filing/0001193125-25-133717.json","markdown":"https://secwatch.observer/filing/0001193125-25-133717.md","text":"https://secwatch.observer/filing/0001193125-25-133717.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/0001193125-25-133717-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/d917067d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T01:16:47.803164+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"}