UroGen Announces FDA Acceptance of its New Drug Application for UGN-102
UroGen Pharma Ltd. - Ordinary Shares (URGN)
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Source: Business Wire
PDUFA goal date set for June 13, 2025UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025."The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN-102 to patients,” said Liz Barrett, President and Chief Executive Officer of UroGen. “UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel approach that could ex
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News
- UroGen Pharma to Report Third Quarter Financial Results on Wednesday, November 6, 2024Business Wire
- ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBCBusiness Wire
- Investors in UroGen Pharma (NASDAQ:URGN) have unfortunately lost 42% over the last five years [Yahoo! Finance]Yahoo! Finance
- UroGen Pharma Ltd. (NASDAQ: URGN) had its "outperform" rating re-affirmed by analysts at Oppenheimer Holdings Inc.. They now have a $40.00 price target on the stock.MarketBeat
- UroGen Pharma announces FDA acceptance of new drug application for UGN-102 [Seeking Alpha]Seeking Alpha
URGN
Earnings
- 8/13/24 - Miss
URGN
Sec Filings
- 10/24/24 - Form SC
- 10/9/24 - Form 4
- 10/9/24 - Form 3
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