{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-100860","form_type":"8-K","ticker":"TBPH","cik":"0001583107","company_name":"Theravance Biopharma, Inc.","filed_at":"2026-08-25T20:52:55+00:00","discovered_at":"2026-08-25T20:54:00.491374+00:00","generated_at":"2026-08-25T20:54:14.698592+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Theravance's ampreloxetine misses primary endpoint in Phase 3 CYPRESS nOH/MSA study","bullets":["Primary endpoint (OHSA composite change at week 8 of randomized withdrawal) not statistically significant; secondary endpoints showed similar trends.","FDA in May 2026 said existing data won't support approval; Type C meeting requested to align on future pivotal trial design.","Post hoc analysis (confirmed symptomatic nOH, n=47): average OHSA diff -1.06 (p=0.001), OHDAS -1.27 (p<0.001), OHQ -1.24 (p<0.001).","Pressor effect confirmed via BP, heart rate, norepinephrine changes; safety consistent with prior studies, no worsening supine hypertension.","Company previously announced acquisition by Zymeworks (June 29, 2026), subject to shareholder approval; deal context for this update."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-100860","json":"https://secwatch.observer/filing/0001104659-26-100860.json","markdown":"https://secwatch.observer/filing/0001104659-26-100860.md","text":"https://secwatch.observer/filing/0001104659-26-100860.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/0001104659-26-100860-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/tm2623927d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-25T20:54:14.698592+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"}