secwatch.observer — SEC 8-K summary
======================================

Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2021-11-15T23:59:59+00:00
Accession:  0001193125-21-329000
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 1.02, 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen Q3 Jelmyto rev $11.4M; ends Allergan pact; shifts UGN-102 trial to single-arm Phase 3
--------------------------------------------------------------------------------

- Q3 2021 net product revenue $11.4M; net loss $30.2M ($1.35/share) vs $28.8M loss ($1.31) in Q3 2020.
- Full-year 2021 revenue guidance $47-51M; operating expense guidance reduced to $137-142M from $155-165M.
- Ceased enrollment in ATLAS Phase 3 for UGN-102; new single-arm Phase 3 trial planned for early 2022; NDA submission expected 2024.
- Mutually terminated license agreement with Allergan effective November 11, 2021.
- Cash and equivalents $110.3M as of Sep 30; Jelmyto site activations up 73% since August 1.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312521329000/0001193125-21-329000-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312521329000/d243248d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-329000

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