secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2021-11-10T23:59:59+00:00
Accession:  0001193125-21-326173
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen to start new Phase 3 study for UGN-102; stops ATLAS enrollment
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- New single-arm Phase 3 pivotal study for UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer expected to start early 2022, enrolling ~220 patients at 90 sites.
- ATLAS trial enrollment halted; patients already enrolled may remain until completion.
- Company believes new study design increases regulatory success probability; NDA submission for UGN-102 remains on track for 2024.
- UGN-301: non-human primate toxicity studies underway; multi-arm Phase 1 study planned early 2022 with combination approaches.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/0001193125-21-326173-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/d244400d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-326173

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