{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-218251","form_type":"8-K","ticker":"DFTX","cik":"0001813814","company_name":"Definium Therapeutics, Inc.","filed_at":"2026-05-12T12:15:16+00:00","discovered_at":"2026-05-12T12:20:00.334864+00:00","generated_at":"2026-05-12T12:22:02.777135+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.4,"calibrated_materiality_score":0.4,"confidence":"high","headline":"Definium doses first patient in Phase 3 Ascend study of DT120 ODT for MDD; topline data expected 2027","bullets":["First patient dosed in Ascend, second Phase 3 pivotal study of DT120 ODT (lysergide tartrate) for major depressive disorder.","Primary endpoint: change from baseline in MADRS score at Week 6 for DT120 ODT 100 µg vs placebo.","Study to enroll 175 participants in the U.S.; topline data from 12-week double-blind period anticipated in 2027.","Ascend design aligns with Emerge Phase 3 and GAD trials; includes 40-week open-label extension and 2:1:2 randomization.","50 µg DT120 arm included to confound dose condition awareness and address functional unblinding concerns."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-218251","json":"https://secwatch.observer/filing/0001193125-26-218251.json","markdown":"https://secwatch.observer/filing/0001193125-26-218251.md","text":"https://secwatch.observer/filing/0001193125-26-218251.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1813814/000119312526218251/0001193125-26-218251-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1813814/000119312526218251/dftx-20260512.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T12:22:02.777135+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"}