secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2025-05-12T23:59:59+00:00
Accession:  0001437749-25-015955
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen Pharma Q1 2025: JELMYTO revenue $20.3M, net loss widens to $43.8M; UGN-102 PDUFA June 13
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- JELMYTO net sales $20.3M (+8% YoY); underlying demand grew 12%.
- Net loss of $43.8M ($0.92 per share) vs $32.3M ($0.87) in Q1 2024.
- Cash and marketable securities $200.4M; FY2025 JELMYTO revenue guidance unchanged at $94–$98M.
- UGN-102 NDA under FDA review; PDUFA target action date June 13, 2025; ODAC meeting May 21.
- UGN-501 acquisition from IconOVir expensed; UGN-103 Phase 3 UTOPIA trial enrollment to complete mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925015955/0001437749-25-015955-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925015955/urgn20250428_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-015955

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer