{"filing":{"accession_number":"0001104659-26-107275","cik":"0001813814","ticker":"DFTX","company_name":"Definium Therapeutics, Inc.","form":"8-K","filing_date":"2026-09-14","report_date":"2026-09-14","primary_document":"tm2625365d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1813814/000110465926107275/tm2625365d1_8k.htm"},"events":[{"id":33145,"run_id":30470,"accession_number":"0001104659-26-107275","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 the Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder, meeting primary and key secondary efficacy endpoints. This represents a material clinical milestone—the third positive Phase 3 trial for DT120 ODT and the second in GAD—with a planned pre-NDA meeting in 4Q 2026 and NDA filing anticipated in 1H 2027.","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-09-14","form":"8-K","submitted_at":null,"items":[{"id":36513,"accession_number":"0001104659-26-107275","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive topline results from the Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder, meeting primary and key secondary efficacy endpoints. This is a material clinical development milestone for a late-stage biopharmaceutical company, advancing toward NDA submission in 1H 2027. While not a traditional earnings release (which reports financial results), this clinical readout is a significant operational and strategic event that would materially affect investor assessment of the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:04:44.461705+00:00","company_name":"","ticker":null,"filing_date":""},{"id":36514,"accession_number":"0001104659-26-107275","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Definium announced positive topline results from the Phase 3 Panorama study of DT120 ODT in generalized anxiety disorder, meeting its primary endpoint and key secondary endpoints. This represents a material clinical milestone for a late-stage biopharmaceutical company—the third positive Phase 3 trial for DT120 ODT and the second in GAD—with planned pre-NDA meeting in 4Q 2026 and NDA filing anticipated in 1H 2027. While this is clinical trial data rather than a traditional earnings release or financial result, it is a material operational and strategic milestone that would significantly affect investor assessment of the company's regulatory pathway and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:04:44.461705+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":36513,"accession_number":"0001104659-26-107275","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive topline results from the Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder, meeting primary and key secondary efficacy endpoints. This is a material clinical development milestone for a late-stage biopharmaceutical company, advancing toward NDA submission in 1H 2027. While not a traditional earnings release (which reports financial results), this clinical readout is a significant operational and strategic event that would materially affect investor assessment of the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:04:44.461705+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-09-14"},{"id":36514,"accession_number":"0001104659-26-107275","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Definium announced positive topline results from the Phase 3 Panorama study of DT120 ODT in generalized anxiety disorder, meeting its primary endpoint and key secondary endpoints. This represents a material clinical milestone for a late-stage biopharmaceutical company—the third positive Phase 3 trial for DT120 ODT and the second in GAD—with planned pre-NDA meeting in 4Q 2026 and NDA filing anticipated in 1H 2027. While this is clinical trial data rather than a traditional earnings release or financial result, it is a material operational and strategic milestone that would significantly affect investor assessment of the company's regulatory pathway and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:04:44.461705+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-09-14"}]}