UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event
UroGen Pharma Ltd. - Ordinary Shares (URGN)
Last urogen pharma ltd. - ordinary shares earnings: 3/2 08:00 am
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Source: Business Wire
New, Single-arm Phase 3 Study Expected to Initiate in Early 2022 PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, is announcing at its virtual Spotlight Event being held today that, following recent discussions with the U.S. Food and Drug Administration (“FDA”), it plans to conduct a new, single-arm Phase 3 pivotal study of UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer (“NMIBC”). This new study, which is expected to initiate in early 2022, is expected to enroll approximately 220 patients across 90 sites.“We have worked diligently with the FDA over the past several years to define the unmet need in low-grade NMIBC, with a particular focus on the intermediate risk population that typically experiences multiple recurrences,” said Liz Barrett, President and Chief Executive Officer of UroGen
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- New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction TherapyBusiness Wire
URGN
Earnings
- 3/14/24 - Miss
URGN
Sec Filings
- 5/8/24 - Form SC
- 4/29/24 - Form 10-K/A
- 3/20/24 - Form 4
- URGN's page on the SEC website