{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-107275","form_type":"8-K","ticker":"DFTX","cik":"0001813814","company_name":"Definium Therapeutics, Inc.","filed_at":"2026-09-14T12:02:40+00:00","discovered_at":"2026-09-14T12:05:00.759607+00:00","generated_at":"2026-09-14T12:05:09.741420+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Definium DT120 Phase 3 in GAD hits primary endpoint; HAM-A -5.1 vs placebo (p<0.0001)","bullets":["Panorama met primary endpoint: HAM-A LS mean change -9.8 vs placebo -4.7, diff -5.1 (p<0.0001, d=0.64).","All key secondary endpoints met; rapid onset by Day 2; response rate 32% vs 14% (p<0.05).","Well tolerated; no new safety signals; discontinuation rates ~10% across arms.","Pre-NDA meeting scheduled 4Q 2026; NDA filing anticipated 1H 2027.","Third positive Phase 3 for DT120 ODT following Emerge (MDD) and Voyage (GAD)."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-107275","json":"https://secwatch.observer/filing/0001104659-26-107275.json","markdown":"https://secwatch.observer/filing/0001104659-26-107275.md","text":"https://secwatch.observer/filing/0001104659-26-107275.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/0001104659-26-107275-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/tm2625365d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-14T12:05:09.741420+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"}