secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2024-05-13T23:59:59+00:00
Accession:  0001193125-24-136728
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen Q1 net loss $32.3M; JELMYTO revenue up 10% to $18.8M; UGN-102 NDA on track
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- Net loss $32.3M ($0.97/share) vs $30.2M ($1.30) in Q1 2023; JELMYTO revenue $18.8M, +10% YoY.
- FY2024 guidance reiterated: JELMYTO revenue $95-102M; operating expenses $175-185M.
- UGN-102 rolling NDA submission to complete Q3 2024; ENVISION 12-month DOR data event June 13.
- IND accepted for UGN-103; Phase 3 in LG-IR-NMIBC planned for 2024.
- Cash $164.5M; OLYMPUS post-hoc shows JELMYTO median duration of response 47.8 months.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524136728/0001193125-24-136728-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524136728/d804276d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-136728

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