{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-114509","form_type":"8-K","ticker":"INVA","cik":"0001080014","company_name":"Innoviva, Inc.","filed_at":"2023-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.146311+00:00","generated_at":"2026-06-08T18:59:57.363060+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Innoviva's zoliflodacin meets primary endpoint in Phase 3 gonorrhea trial","bullets":["Zoliflodacin met primary efficacy endpoint with non-inferiority to ceftriaxone+azithromycin in urogenital gonorrhea (point estimate 5.3% difference, 95% CI 1.4%-8.7%).","Microbiological cure rates >90% in both arms; 90.9% for zoliflodacin vs 96.8% for comparator in Micro-ITT population.","Secondary analyses at rectal and pharyngeal sites showed comparable cure rates but were not powered for statistical significance.","Safety profile favorable: no serious AEs, discontinuations, or deaths; headache (9.9%) most common TEAE for zoliflodacin.","Global Phase 3 trial enrolled 927 patients across 16 sites in US, South Africa, Belgium, Netherlands, and Thailand."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-114509","json":"https://secwatch.observer/filing/0001104659-23-114509.json","markdown":"https://secwatch.observer/filing/0001104659-23-114509.md","text":"https://secwatch.observer/filing/0001104659-23-114509.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/0001104659-23-114509-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/tm2327472d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T18:59:57.363060+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"}