{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-266731","form_type":"8-K","ticker":"ELVN","cik":"0001672619","company_name":"Enliven Therapeutics, Inc.","filed_at":"2026-06-11T12:09:27+00:00","discovered_at":"2026-06-11T12:10:00.354493+00:00","generated_at":"2026-06-11T12:10:08.178703+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Enliven reports 61% overall MMR at 80 mg QD in Phase 1b; FDA aligns on Phase 3 design for ELVN-001","bullets":["161 patients enrolled; median treatment duration 35 weeks; 76% remain on study as of March 10, 2026 cutoff.","61% overall MMR and 48% achieved MMR by 24 weeks in the 80 mg QD Phase 1b cohort (n=28 evaluable).","70% of patients had 3+ prior TKIs; 62% had prior asciminib; response rates comparable regardless of prior asciminib exposure.","Only 6% discontinued due to adverse events; Grade ≥3 TEAEs at 80 mg QD were 24% with thrombocytopenia the most common at 6%.","FDA endorsed 80 mg QD as Phase 3 dose and 2L+ patient population; ENABLE-2 pivotal trial expected to initiate H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-266731","json":"https://secwatch.observer/filing/0001193125-26-266731.json","markdown":"https://secwatch.observer/filing/0001193125-26-266731.md","text":"https://secwatch.observer/filing/0001193125-26-266731.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1672619/000119312526266731/0001193125-26-266731-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1672619/000119312526266731/d202685d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T12:10:08.178703+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"}