{"filing":{"accession_number":"0001104659-26-100860","cik":"0001583107","ticker":"TBPH","company_name":"Theravance Biopharma, Inc.","form":"8-K","filing_date":"2026-08-25","report_date":"2026-08-25","primary_document":"tm2623927d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/tm2623927d1_8k.htm"},"events":[{"id":29541,"run_id":27052,"accession_number":"0001104659-26-100860","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Theravance disclosed results of the Phase 3 CYPRESS Study (0197) for ampreloxetine in nOH/MSA, which missed its primary endpoint (OHSA composite score at week 8 was not statistically significant). The company also disclosed post hoc analyses and FDA interactions, including a Type B meeting in May 2026 where the FDA indicated the existing data would not support approval but suggested an additional pivotal trial could offer a potential path forward, and a requested Type C meeting in July 2026 to align on future study design. This is a material clinical development milestone and regulatory setback for a key pipeline asset, disclosed under Item 8.01 (Other Events).","company_name":"Theravance Biopharma, Inc.","ticker":"TBPH","filing_date":"2026-08-25","form":"8-K","submitted_at":null,"items":[{"id":31858,"accession_number":"0001104659-26-100860","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Theravance disclosed results of the Phase 3 CYPRESS Study (0197) for ampreloxetine in nOH/MSA, which missed its primary endpoint (OHSA composite score at week 8 was not statistically significant). The company also disclosed post hoc analyses and FDA interactions, including a Type B meeting in May 2026 where the FDA indicated the existing data would not support approval but suggested an additional pivotal trial could offer a potential path forward, and a requested Type C meeting in July 2026 to align on future study design. This is a material clinical development milestone and regulatory setback for a key pipeline asset, disclosed under Item 8.01 (Other Events).","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-25T20:53:50.581823+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":31858,"accession_number":"0001104659-26-100860","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Theravance disclosed results of the Phase 3 CYPRESS Study (0197) for ampreloxetine in nOH/MSA, which missed its primary endpoint (OHSA composite score at week 8 was not statistically significant). The company also disclosed post hoc analyses and FDA interactions, including a Type B meeting in May 2026 where the FDA indicated the existing data would not support approval but suggested an additional pivotal trial could offer a potential path forward, and a requested Type C meeting in July 2026 to align on future study design. This is a material clinical development milestone and regulatory setback for a key pipeline asset, disclosed under Item 8.01 (Other Events).","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-25T20:53:50.581823+00:00","company_name":"Theravance Biopharma, Inc.","ticker":"TBPH","filing_date":"2026-08-25"}]}