On July 6, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it will host a data event on Thursday, July 27th, 2023 at 10:00 a.m. Eastern Time (Press release, UroGen Pharma, JUL 6, 2023, View Source [SID1234633090]). The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and will highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials.
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For ENVISION, UroGen will provide complete response rate (the primary endpoint) from approximately 240 patients who completed the study; and for ATLAS, the predecessor to ENVISION, UroGen will provide disease free survival (the primary endpoint) as well as complete response, durability, and safety data from approximately 280 patients that completed the study. The program will also feature Key Opinion Leaders and a panel discussion on the treatment of LG-IR-NMIBC.
Please register for the webinar under the Events & Presentations section of the Company’s Investor Relations site (View Source).
Following the live audio webcast, a replay will be available on the Company’s website (View Source).
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.