Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. - Ordinary Shares (URGN)
Last urogen pharma ltd. - ordinary shares earnings: 3/2 08:00 am
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65% Complete Response Rate at Three MonthsDuration of Response Estimated to be 72.5% at Nine Months (12-Months from Initiation of Therapy) by Kaplan-Meier Method; Median Duration of Response was Not ReachedTreatment with UGN-102 was Generally Well Tolerated, with Mostly Mild to Moderate Adverse Events Reported Phase 3 Pivotal Trial Evaluating UGN-102 Versus Current Standard of Care Expected to Start by Year-End PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN) today announced final topline results from the single-arm, open-label OPTIMA II Phase 2b trial evaluating the efficacy and safety of investigational UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy. In this subset of patients, duration of response at nine months (12-months from st
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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