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FDA批准UroGen的ZUSDURI膀胱内注射液作为复发性低级别中度风险非肌肉浸润性膀胱癌的药物
2025-06-13 01:29
- 乌龙制药(URGN) 0
- Environmental Impact Acquisition Corp. Class A(ENVI) 0
- Sionna Therapeutics, Inc.(SION) 0
- ZUSDURI (formerly known as UGN-102) is a localized medication designed for potent tumor ablation delivered by innovative RTGel® technology.
- Approval supported by pivotal Phase 3 ENVISION trial demonstrating 78% of patients achieved complete response (CR) at 3 months, and 79% of those responders maintained complete response at 12 months after the 3-month visit (DOR).
- Manageable safety profile characterized primarily by mild to moderate lower urinary tract symptoms.
- An estimated 59,000 LG-IR-NMIBC patients in the U.S. recur each year and face repeat surgeries.
- Conference call and webcast to be held on June 13, 2025, at 8:30 AM ET
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