secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2025-08-07T23:59:59+00:00
Accession:  0001437749-25-025242
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen reports Q2 loss of $49.9M; launches ZUSDURI after June FDA approval
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- ZUSDURI (mitomycin) FDA-approved June 12 for recurrent LG-IR-NMIBC; now commercially available.
- JELMYTO Q2 net revenue $24.2M (+11% vs Q2 2024); FY guidance $94-98M unchanged.
- Net loss $49.9M ($1.05/share) vs $33.4M ($0.82) in Q2 2024; operating loss $41.4M.
- Cash and marketable securities $161.6M at June 30, 2025.
- Enrollment complete in Phase 3 UTOPIA trial for next-gen mitomycin UGN-103.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925025242/0001437749-25-025242-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925025242/urgn20250804_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-025242

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