US FDA approves Urogen's bladder cancer drug
Urogen Pharma's drug receives FDA approval for bladder cancer treatment. This approval may significantly enhance URGN's market position and revenue potential.
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URGN
UroGen Pharma Ltd. · NASDAQ · Healthcare
Price$43.82-0.62% · −$0.28
Market cap2.13BEquity value
P / E-22.1Trailing ratio
Volume418.45KLatest session
Market data
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UroGen Pharma Stock Receives Downgrade As Analyst Cites FDA Panel Setback For Key Bladder Cancer Drug
URGN downgraded from Buy to Neutral by HC Wainwright analyst. FDA committee voted against UGN-102's benefit-risk profile. Timely approval likelihood for UGN-102 is now significantly lowered. URGN's financial position remains stable with $200 million cash. Next-generation candidates UGN-103 and UGN-104 are in development.
View signal analysisUroGen Pharma Touts Four-Year Response With Urothelial Cancer Drug Study, Highlights Potential For Bladder Cancer Candidates
URGN's Jelmyto shows nearly four years of response duration in a study. OPTIMA II phase 2b study of UGN-102 shows 24.2 months response duration. UGN-102 NDA submitted; FDA PDUFA date set for June 13, 2025. Safety data for UGN-301 indicates promise in bladder cancer treatments. URGN stock rose 7.65% following positive news.
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