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 Bladd...
UroGen Pharma Ltd. - Ordinary Shares (URGN)
Last urogen pharma ltd. - ordinary shares earnings: 3/2 08:00 am
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Source: Yahoo! Finance
Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041 PRINCETON, N.J., April 15, 2024 BUSINESS WIRE )--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The UGN-103 formulation uses UroGen's RTGel ® platform technology, a proprietary sustained-release, reverse-thermal hydrogel that can improve the therapeutic profiles of existing drugs. UGN-103 is anticipated to provide several advantages related to production,
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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 CancerBusiness Wire
- UroGen Pharma Ltd.'s (NASDAQ:URGN) high institutional ownership speaks for itself as stock continues to impress, up 11% over last week [Yahoo! Finance]Yahoo! Finance
URGN
Earnings
- 3/14/24 - Miss
URGN
Sec Filings
- 4/29/24 - Form 10-K/A
- 3/20/24 - Form 4
- 3/18/24 - Form 144
- URGN's page on the SEC website