UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
UroGen Pharma Ltd. - Ordinary Shares (URGN)
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Source: Business Wire
Data Demonstrates Complete Response (CR) Rate of 57 Percent in Patients with LG UTUC All Evaluated Patients in CR Remain Disease Free at Six Months Rolling Submission of New Drug Application (NDA) Initiated in December 2018 NEW YORK--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of
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News
- UroGen Pharma Ltd. (NASDAQ: URGN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $54.00 price target on the stock.MarketBeat
- UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers [Yahoo! Finance]Yahoo! Finance
- UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial CancersBusiness Wire
- UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder CancerBusiness Wire
URGN
Earnings
- 3/14/24 - Miss
URGN
Sec Filings
- 3/20/24 - Form 4
- 3/18/24 - Form 144
- 3/14/24 - Form 10-K
- URGN's page on the SEC website