{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-082048","form_type":"8-K","ticker":"TBPH","cik":"0001583107","company_name":"Theravance Biopharma, Inc.","filed_at":"2025-08-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.416766+00:00","generated_at":"2026-05-17T10:13:18.432750+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Theravance Biopharma completes Phase 3 enrollment for ampreloxetine in nOH due to MSA; topline Q1 2026","bullets":["Enrollment completed in open-label portion of pivotal Phase 3 CYPRESS study (NCT05696717) for nOH due to MSA.","Expected topline results in Q1 2026; if positive, plans for expedited NDA submission and priority FDA review.","Ampreloxetine has Orphan Drug Designation in the U.S.; addresses ~40,000 patients with symptomatic nOH due to MSA.","Primary endpoint is change in OHSA composite score from randomized-withdrawal baseline to Week 8."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-082048","json":"https://secwatch.observer/filing/0001104659-25-082048.json","markdown":"https://secwatch.observer/filing/0001104659-25-082048.md","text":"https://secwatch.observer/filing/0001104659-25-082048.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/0001104659-25-082048-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/tm2524263d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T10:13:18.432750+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}