{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-281988","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2022-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.643058+00:00","generated_at":"2026-06-21T23:08:40.380604+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 JELMYTO revenue up 41% to $16.1M; net loss narrows to $25.8M","bullets":["JELMYTO net product revenue $16.1M (+41% YoY); operating loss improved to $18.1M from $23.4M.","Net loss $25.8M ($1.13/share) vs $30.2M ($1.35/share) in Q3 2021; cash, cash equivalents and marketable securities $95.9M.","ENVISION Phase 3 trial for UGN-102 enrollment completion expected as soon as end of Nov 2022; NDA submission anticipated H1 2024.","FDA authorized extension of JELMYTO in-use period from 8 to 96 hours following reconstitution.","Appointed Dr. Leana S. Wen and Dan Wildman to the Board of Directors."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-281988","json":"https://secwatch.observer/filing/0001193125-22-281988.json","markdown":"https://secwatch.observer/filing/0001193125-22-281988.md","text":"https://secwatch.observer/filing/0001193125-22-281988.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312522281988/0001193125-22-281988-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312522281988/d405971d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T23:08:40.380604+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":[{"claim_id":"4707c104ba229a5dd68cd8f8daf10db03b7821c8","claim":"UroGen Pharma Ltd. reported the third quarter ended September 30, 2022 results: revenue $16.1 million.","evidence_excerpt":"invasive bladder cancer (LG-IR-NMIBC) expected as soon as the end of November 2022; NDA submission anticipated in first half of 2024 • Reported JELMYTO ® net product revenue of $16.1 million, an increase of 41% from the same period last year • FDA authorized extension of the in-use period for JELMYTO ® admixture from 8 to 96 hours following reconstitution further","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1668243/000119312522281988/0001193125-22-281988-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the third quarter ended September 30, 2022"},{"label":"Revenue","value":"$16.1 million"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}