UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer
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
Approval Based on Phase 3 Trial Results Showing a Complete Response Rate of 58% Median Duration of Response Has Not Been ReachedTherapy Provides an Effective, Kidney-Sparing Option for Patients With This Rare and Difficult-To-Treat CancerFirst-in-Class Approval Validates UroGen’s Innovative Technology and Future Opportunity Across its Specialty Cancers and Urologic Diseases PortfolioCompany to Host Conference Call on Thursday, April 16 at 8:30 AM Eastern Time PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto™ (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.Jelmyto consis
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- UroGen Pharma to Present at the Piper Sandler 37th Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
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- UroGen Pharma (URGN) Closes Q3 2025 With $127.4 Million in Cash Amid Rising R&D Costs [Yahoo! Finance]Yahoo! Finance
- Analysts Have Made A Financial Statement On UroGen Pharma Ltd.'s (NASDAQ:URGN) Third-Quarter Report [Yahoo! Finance]Yahoo! Finance
URGN
Earnings
- 11/6/25 - Beat
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Analyst Actions
- 10/27/25 - HC Wainwright
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Sec Filings
- 12/1/25 - Form 4
- 12/1/25 - Form 4
- 12/1/25 - Form 4
- URGN's page on the SEC website