{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-033466","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2025-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.086625+00:00","generated_at":"2026-05-16T23:46:05.569451+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M","bullets":["ZUSDURI achieved net product revenue of $1.8M in Q3; October 2025 preliminary demand revenue estimate of $4.5M, with 592 activated sites and 54 prescribers since July launch.","JELMYTO net revenue $25.7M (+13% YoY underlying demand growth); full-year JELMYTO guidance unchanged at $94-98M, op expenses $215-225M.","Net loss of $33.3M ($0.69/share) vs $23.7M ($0.51) in Q3 2024; cash $127.4M as of Sept 30, 2025.","UGN-103 Phase 3 UTOPIA shows 77.8% CRR; FDA agrees to NDA submission plan; NDA expected H2 2026 with potential approval 2027.","UGN-301 (zalifrelimab) development discontinued; UroGen terminates license with Agenus."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-033466","json":"https://secwatch.observer/filing/0001437749-25-033466.json","markdown":"https://secwatch.observer/filing/0001437749-25-033466.md","text":"https://secwatch.observer/filing/0001437749-25-033466.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/0001437749-25-033466-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/urgn20251031_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:46:05.569451+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"}