{"filing":{"accession_number":"0001104659-26-076091","cik":"0001813814","ticker":"DFTX","company_name":"Definium Therapeutics, Inc.","form":"8-K","filing_date":"2026-06-22","report_date":null,"primary_document":"tm2618434d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1813814/000110465926076091/tm2618434d1_8k.htm"},"events":[{"id":12608,"run_id":11183,"accession_number":"0001104659-26-076091","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Definium announced positive topline results from its Phase 3 Emerge study of DT120 ODT for major depressive disorder, meeting the primary endpoint with an 8.1-point placebo-adjusted MADRS improvement (p\u003c0.0001) and demonstrating rapid, durable efficacy with a favorable safety profile. This represents a material clinical development milestone advancing the company's late-stage program toward potential FDA submission.","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-06-22","form":"8-K","submitted_at":null,"items":[{"id":9508,"accession_number":"0001104659-26-076091","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive topline results from the Phase 3 Emerge study of DT120 ODT for major depressive disorder, meeting the primary endpoint and all key secondary endpoints with statistically significant efficacy (8.1 point MADRS placebo-adjusted change at Week 6, p\u003c0.0001) and favorable safety profile. This represents a material clinical development milestone for a late-stage biopharmaceutical company, but does not fit the earnings_release category (which typically applies to financial results) nor any other specific taxonomy type. The event is clearly operational/strategic in nature—a significant clinical trial success that advances the company's development program toward potential FDA submission—making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-22T12:03:33.654537+00:00","company_name":"","ticker":null,"filing_date":""},{"id":9509,"accession_number":"0001104659-26-076091","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Definium announced positive topline results from its Phase 3 Emerge study of DT120 ODT in major depressive disorder, meeting the primary endpoint with an 8.1-point placebo-adjusted MADRS improvement (p\u003c0.0001) and demonstrating rapid, durable efficacy with no serious adverse events. This represents a material clinical milestone for a late-stage biopharmaceutical company, but does not fit the earnings_release category (which typically applies to financial results) nor any other specific event type. The disclosure is clearly operational and material to investors assessing the company's development progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-22T12:03:33.654537+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":9508,"accession_number":"0001104659-26-076091","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive topline results from the Phase 3 Emerge study of DT120 ODT for major depressive disorder, meeting the primary endpoint and all key secondary endpoints with statistically significant efficacy (8.1 point MADRS placebo-adjusted change at Week 6, p\u003c0.0001) and favorable safety profile. This represents a material clinical development milestone for a late-stage biopharmaceutical company, but does not fit the earnings_release category (which typically applies to financial results) nor any other specific taxonomy type. The event is clearly operational/strategic in nature—a significant clinical trial success that advances the company's development program toward potential FDA submission—making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-22T12:03:33.654537+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-06-22"},{"id":9509,"accession_number":"0001104659-26-076091","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Definium announced positive topline results from its Phase 3 Emerge study of DT120 ODT in major depressive disorder, meeting the primary endpoint with an 8.1-point placebo-adjusted MADRS improvement (p\u003c0.0001) and demonstrating rapid, durable efficacy with no serious adverse events. This represents a material clinical milestone for a late-stage biopharmaceutical company, but does not fit the earnings_release category (which typically applies to financial results) nor any other specific event type. The disclosure is clearly operational and material to investors assessing the company's development progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-22T12:03:33.654537+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-06-22"}]}