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UroGen Pharma Announces UGN-102 Long-Term Results In The Phase 3 ENVISION Trial, Potentially Paving The Way For First FDA-Approved Treatment For LG-IR-NMIBC; UGN-102 Demonstrated 82.3% Duration Of Response At 12 Months In Patients Who Achieved...

Benzinga ·  Dec 6 04:18

UroGen Pharma Announces UGN-102 Long-Term Results In The Phase 3 ENVISION Trial, Potentially Paving The Way For First FDA-Approved Treatment For LG-IR-NMIBC; UGN-102 Demonstrated 82.3% Duration Of Response At 12 Months In Patients Who Achieved Complete Response At 3 Months; 79.6% Complete Response Rate At 3 Months

  • UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months
  • 79.6% complete response rate at 3 months in patients treated with UGN-102
  • Safety profile consistent with prior clinical trials of UGN-102

UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the presentation of the Phase 3 ENVISION trial's efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a mitomycin-based intravesical solution, resulted in a high and clinically meaningful complete response rate that was durable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).

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