{"filing":{"accession_number":"0001193125-26-384403","cik":"0001813814","ticker":"DFTX","company_name":"Definium Therapeutics, Inc.","form":"8-K","filing_date":"2026-09-08","report_date":"2026-09-08","primary_document":"dftx-20260908.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/dftx-20260908.htm"},"events":[{"id":31807,"run_id":29207,"accession_number":"0001193125-26-384403","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The disclosure announces FDA Breakthrough Therapy designation for DT120 ODT in major depressive disorder, following positive Phase 3 Emerge study results showing statistically significant efficacy (8.1-point placebo-adjusted MADRS improvement, p\u003c0.0001). This is a material regulatory milestone that accelerates development and review of an innovative medicine for a serious condition with significant unmet need, but does not fit the specific operational categories (workforce reduction, material contract, partnership, product milestone). The event is clearly operational/strategic—a regulatory achievement that advances the company's lead program—rather than financial, governance, legal, or existential in nature.","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-09-08","form":"8-K","submitted_at":null,"items":[{"id":34804,"accession_number":"0001193125-26-384403","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Breakthrough Therapy designation for DT120 ODT in major depressive disorder, following positive Phase 3 Emerge study results showing statistically significant efficacy (8.1-point placebo-adjusted MADRS improvement, p\u003c0.0001). This is a material regulatory milestone that accelerates development and review of an innovative medicine for a serious condition with significant unmet need, but does not fit the specific operational categories (workforce reduction, material contract, partnership, product milestone). The event is clearly operational/strategic—a regulatory achievement that advances the company's lead program—rather than financial, governance, legal, or existential in nature.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-08T12:01:52.401380+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":34804,"accession_number":"0001193125-26-384403","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Breakthrough Therapy designation for DT120 ODT in major depressive disorder, following positive Phase 3 Emerge study results showing statistically significant efficacy (8.1-point placebo-adjusted MADRS improvement, p\u003c0.0001). This is a material regulatory milestone that accelerates development and review of an innovative medicine for a serious condition with significant unmet need, but does not fit the specific operational categories (workforce reduction, material contract, partnership, product milestone). The event is clearly operational/strategic—a regulatory achievement that advances the company's lead program—rather than financial, governance, legal, or existential in nature.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-08T12:01:52.401380+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-09-08"}]}