{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-302283","form_type":"8-K","ticker":"KURA","cik":"0001422143","company_name":"Kura Oncology, Inc.","filed_at":"2022-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:50.600748+00:00","generated_at":"2026-06-21T06:04:31.426552+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Kura Oncology reports ziftomenib 30% CR rate at 600 mg in NPM1-mutant AML; FDA agrees on registration-enabling trial","bullets":["Phase 1b trial at 600 mg showed 30% CR (6/20) in NPM1-mutant AML vs 17% at 200 mg; median duration of response not reached.","FDA Type C meeting confirmed 600 mg as recommended Phase 2 dose; agreement on key registration study design elements.","Phase 2 registration-directed trial expected to dose first patient in Q1 2023; combination studies with venetoclax/FLT3 planned.","Differentiation syndrome observed: 20% in NPM1-mutant patients at 600 mg (only 5% Grade 3); higher in KMT2A-rearranged patients.","No drug-induced QTc prolongation; six discontinuations none treatment-related; ziftomenib well tolerated overall."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-302283","json":"https://secwatch.observer/filing/0001193125-22-302283.json","markdown":"https://secwatch.observer/filing/0001193125-22-302283.md","text":"https://secwatch.observer/filing/0001193125-22-302283.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/0001193125-22-302283-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/d646465d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T06:04:31.426552+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"}