{"filing":{"accession_number":"0001104659-26-094528","cik":"0001813814","ticker":"DFTX","company_name":"Definium Therapeutics, Inc.","form":"8-K","filing_date":"2026-08-12","report_date":"2026-08-12","primary_document":"tm2622948d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1813814/000110465926094528/tm2622948d1_8k.htm"},"events":[{"id":27059,"run_id":24630,"accession_number":"0001104659-26-094528","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Definium announced positive topline results from its Phase 3 Voyage study of DT120 ODT for generalized anxiety disorder, meeting the primary endpoint with statistically significant efficacy (p\u003c0.0001, Cohen's d=0.81). This represents a material clinical development milestone for the company's lead product candidate.","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-08-12","form":"8-K","submitted_at":null,"items":[{"id":28425,"accession_number":"0001104659-26-094528","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses positive topline results from Definium's Phase 3 Voyage study of DT120 ODT for generalized anxiety disorder, meeting its primary endpoint with statistically significant efficacy (p\u003c0.0001, Cohen's d=0.81). This is a material clinical development milestone for a late-stage biopharmaceutical company with a lead product candidate, affecting investor assessment of the company's regulatory pathway and commercial prospects. While the disclosure is framed as a press release under Item 7.01 (Regulation FD Disclosure) rather than a formal earnings release, it represents a significant operational and strategic milestone in the company's clinical development program.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-12T12:06:49.779346+00:00","company_name":"","ticker":null,"filing_date":""},{"id":28426,"accession_number":"0001104659-26-094528","item_number":"8.01","item_title":"Other Events.","event_type":"earnings_release","event_domain":"financial","is_material":true,"confidence":0.92,"reasoning":"Definium announced positive topline results from its Phase 3 Voyage study of DT120 ODT in generalized anxiety disorder, meeting the primary endpoint with a statistically significant placebo-adjusted HAM-A score reduction of 5.4 points (p\u003c0.0001, Cohen's d=0.81). While this is a clinical trial result rather than financial earnings, it constitutes a material disclosure of significant clinical progress for a late-stage biopharmaceutical company whose value is primarily driven by pipeline success. The announcement was made via press release (EX-99.1) and presentation (EX-99.2) posted to the company's website, following the standard format of an earnings_release disclosure for biotech firms reporting major clinical milestones.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-12T12:06:49.779346+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":28425,"accession_number":"0001104659-26-094528","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses positive topline results from Definium's Phase 3 Voyage study of DT120 ODT for generalized anxiety disorder, meeting its primary endpoint with statistically significant efficacy (p\u003c0.0001, Cohen's d=0.81). This is a material clinical development milestone for a late-stage biopharmaceutical company with a lead product candidate, affecting investor assessment of the company's regulatory pathway and commercial prospects. While the disclosure is framed as a press release under Item 7.01 (Regulation FD Disclosure) rather than a formal earnings release, it represents a significant operational and strategic milestone in the company's clinical development program.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-12T12:06:49.779346+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-08-12"},{"id":28426,"accession_number":"0001104659-26-094528","item_number":"8.01","item_title":"Other Events.","event_type":"earnings_release","event_domain":"financial","is_material":true,"confidence":0.92,"reasoning":"Definium announced positive topline results from its Phase 3 Voyage study of DT120 ODT in generalized anxiety disorder, meeting the primary endpoint with a statistically significant placebo-adjusted HAM-A score reduction of 5.4 points (p\u003c0.0001, Cohen's d=0.81). While this is a clinical trial result rather than financial earnings, it constitutes a material disclosure of significant clinical progress for a late-stage biopharmaceutical company whose value is primarily driven by pipeline success. The announcement was made via press release (EX-99.1) and presentation (EX-99.2) posted to the company's website, following the standard format of an earnings_release disclosure for biotech firms reporting major clinical milestones.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-12T12:06:49.779346+00:00","company_name":"Definium Therapeutics, Inc.","ticker":"DFTX","filing_date":"2026-08-12"}]}