UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer

UroGen Pharma Ltd.

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.

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