UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel
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
Jelmyto® granted expedited review in IsraelJelmyto is the only US FDA approved treatment for low-grade upper tract urothelial cancer PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and Neopharm group (“Neopharm”), today announced an exclusive license for Neopharm to market and sell Jelmyto® (mitomycin) for pyelocalyceal solution in Israel, subject to regulatory approval. Jelmyto is the first and only U.S. Food and Drug Administration approved medicine for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).Neopharm will lead the regulatory process in Israel, which is supported by the results from the Phase 3 OLYMPUS trial that showed Jelmyto achieved clinically significant disease eradication in adults with LG-UTUC.“We are excited to work with Neopharm and take the first step in making Jelmyto available to p
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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