secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2024-06-13T23:59:59+00:00
Accession:  0001193125-24-160413
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer
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- 12-month DOR KM estimate for CR patients: 82.3% (95% CI: 75.9%-87.1%); predicted median DOR of 40 months.
- ENVISION met primary endpoint with 79.6% CR rate at 3 months; safety profile mild-to-moderate.
- Rolling NDA submission to FDA for UGN-102 to complete Q3 2024; potential acceptance Q4 2024, approval Q1/Q2 2025.
- If approved, UGN-102 would be first FDA-approved medicine for LG-IR-NMIBC; addressable market over $5B (82K patients, $16-19K/dose).
- UGN-102 offers a non-surgical alternative to TURBT; ~68% of patients have 2+ recurrences and repeated TURBT carries adverse event risks.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/0001193125-24-160413-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/d852084d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-160413

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