{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-276676","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2023-11-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.003373+00:00","generated_at":"2026-06-08T03:42:30.255824+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"UroGen Q3 JELMYTO revenue $20.9M (+30% YoY); FDA agrees to rolling NDA for UGN-102","bullets":["JELMYTO net product revenue $20.9M in Q3 2023, up ~30% from $16.1M in Q3 2022.","FDA agreed to rolling NDA for UGN-102 in LG-IR-NMIBC starting Jan 2024; ENVISION trial showed 79.2% CRR at 3 months.","Net loss improved to $21.9M ($0.68/sh) from $25.8M ($1.13/sh) in Q3 2022.","Cash and marketable securities $153.9M as of Sep 30, 2023; FY 2023 revenue guidance reiterated at $76-86M.","ATLAS trial met primary endpoint; 55% reduction in risk of recurrence/progression/death."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-276676","json":"https://secwatch.observer/filing/0001193125-23-276676.json","markdown":"https://secwatch.observer/filing/0001193125-23-276676.md","text":"https://secwatch.observer/filing/0001193125-23-276676.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/0001193125-23-276676-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/d437259d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T03:42:30.255824+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":"b53080e17e92a10cfd7e3a161aed6c2128085f22","claim":"UroGen Pharma Ltd. reported the third quarter ended September 30, 2023 results: revenue $20.9 million, net income a net loss of $21.9 million, EPS basic and diluted net loss per ordinary share of $0.68. Guidance reaffirmed.","evidence_excerpt":"--- EX-99.1 (EX-99.1) --- EX-99.1 Exhibit 99.1 UroGen Pharma Reports Third Quarter 2023 Financial Results • Continued strong growth with JELMYTO ® net product revenues of $20.9 million in Q3 2023; an increase of ~30% from the same period last year • Agreement with United States Food & Drug Administration (FDA) to proceed with rolling New Drug Application (NDA)","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/0001193125-23-276676-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the third quarter ended September 30, 2023"},{"label":"Revenue","value":"$20.9 million"},{"label":"Net income","value":"a net loss of $21.9 million"},{"label":"EPS","value":"basic and diluted net loss per ordinary share of $0.68"},{"label":"Guidance","value":"reaffirmed"},{"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"}