{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-061361","form_type":"8-K","ticker":"DFTX","cik":"0001813814","company_name":"Definium Therapeutics, Inc.","filed_at":"2024-03-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.643253+00:00","generated_at":"2026-06-05T01:49:11.294679+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA grants Breakthrough Therapy Designation to MindMed's MM120 for GAD; Phase 2b shows durable 12-week effect","bullets":["FDA breakthrough designation for MM120 (lysergide d-tartrate) to treat generalized anxiety disorder.","Phase 2b met key secondary endpoint: MM120 100 µg showed 7.7-point HAM-A improvement vs placebo at Week 12 (p<0.003).","65% clinical response rate and 48% clinical remission rate sustained to Week 12 from a single dose.","Plans End-of-Phase 2 meeting with FDA in H1 2024, Phase 3 initiation in H2 2024.","Terminated ATM prospectus for up to $100M of common shares; no new sales until new prospectus filed."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-061361","json":"https://secwatch.observer/filing/0001193125-24-061361.json","markdown":"https://secwatch.observer/filing/0001193125-24-061361.md","text":"https://secwatch.observer/filing/0001193125-24-061361.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1813814/000119312524061361/0001193125-24-061361-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1813814/000119312524061361/d682854d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T01:49:11.294679+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"}