News Releases

Year

Apr 17, 2024

UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers

Subgroup analysis of the UGN-102 ATLAS Trial in patients with new versus recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Three independent long-term real-world analyses of JELMYTO® (mitomycin) for pyelocalyceal solution exploring its use in broad patient types

Apr 15, 2024

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

UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024 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

Apr 03, 2024

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

PRINCETON, N.J. --(BUSINESS WIRE)--Apr. 3, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S.

Mar 14, 2024

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission Announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement

Mar 08, 2024

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J. --(BUSINESS WIRE)--Mar. 8, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 12 new

Mar 04, 2024

UroGen Pharma to Report Fourth Quarter and Full-Year 2023 Financial Results on Thursday, March 14, 2024

Conference Call and Webcast Scheduled for Thursday, March 14, 2024 , at 10:00 AM ET PRINCETON, N.J. --(BUSINESS WIRE)--Mar. 4, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,

Feb 26, 2024

UroGen Pharma to Present at TD Cowen 44th Annual Health Care Conference

- Presentation March 4, 2024 at 1:30 PM ET - PRINCETON, N.J. --(BUSINESS WIRE)--Feb. 26, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will present at

Feb 01, 2024

UroGen Pharma to Participate at Upcoming Investor Conferences

– Guggenheim 6th Annual Biotechnology Conference – – Oppenheimer 34th Annual Healthcare Life Sciences Conference – PRINCETON, N.J. --(BUSINESS WIRE)--Feb. 1, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat

Jan 24, 2024

UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102

PRINCETON, N.J. --(BUSINESS WIRE)--Jan. 24, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the submission of the Chemistry, Manufacturing, and Controls (CMC) section

Jan 17, 2024

UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

PRINCETON, N.J. --(BUSINESS WIRE)--Jan. 17, 2024-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel

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