UroGen Pharma Ltd. (URGN)

US — Healthcare Sector
Peers: KOD  MNMD  XNCR  TNGX  NRIX  OCS  BBOT  ANAB  PHAT  PROK 

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News

New Long-Term Follow-Up Data from OPTIMA II Study of UGN-102 Demonstrates Median Duration of Response of Two Years in Patients with LG-IR-NMIBC
URGN
Published: April 27, 2025 by: Business Wire
Sentiment: Neutral

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 new data from the OPTIMA II Phase 2b study of UGN‑102 (mitomycin) for intravesical solution demonstrate clinically meaningful two-year duration of response (24.2 months) by Kaplan-Meier analysis. UGN-102 is UroGen's sustained-release formulation of mitomycin being developed for the tre.

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image for news New Long-Term Follow-Up Data from OPTIMA II Study of UGN-102 Demonstrates Median Duration of Response of Two Years in Patients with LG-IR-NMIBC
UroGen Pharma Announces Encouraging Results from a Phase 1 Dose-Escalation Study Evaluating UGN-301 in Non-Muscle Invasive Bladder Cancer
URGN
Published: April 26, 2025 by: Business Wire
Sentiment: Neutral

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 encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC). "The early safety profile and clinical activity results fro.

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image for news UroGen Pharma Announces Encouraging Results from a Phase 1 Dose-Escalation Study Evaluating UGN-301 in Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. (URGN) Q4 2024 Earnings Call Transcript
URGN
Published: March 10, 2025 by: Seeking Alpha
Sentiment: Neutral

UroGen Pharma Ltd. (NASDAQ:URGN ) Q4 2024 - Earnings Conference Call March 10, 2025 10:00 AM ET Company Participants Vincent Perrone - Head of IR Liz Barrett - President and CEO Mark Schoenberg - CMO David Lin - CCO Chris Degnan - CFO Conference Call Participants Michael Schmidt - Guggenheim Raghuram Selvaraju - H.

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image for news UroGen Pharma Ltd. (URGN) Q4 2024 Earnings Call Transcript
Urogen Pharma (URGN) Reports Q4 Loss, Lags Revenue Estimates
URGN
Published: March 10, 2025 by: Zacks Investment Research
Sentiment: Negative

Urogen Pharma (URGN) came out with a quarterly loss of $0.80 per share versus the Zacks Consensus Estimate of a loss of $0.74. This compares to loss of $0.72 per share a year ago.

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image for news Urogen Pharma (URGN) Reports Q4 Loss, Lags Revenue Estimates
UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102
URGN
Published: February 14, 2025 by: Business Wire
Sentiment: Neutral

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 results from the subgroup analyses of the pivotal ENVISION study evaluating the impact of tumor burden and focality on the response to UGN-102, an investigational drug in development for treatment of LG-IR-NMIBC. Analyses of pre-specified subgroups showed comparable CR rates and DOR pa.

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image for news UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102

About UroGen Pharma Ltd. (URGN)

  • IPO Date 2017-05-04
  • Website https://www.urogen.com
  • Industry Biotechnology
  • CEO Elizabeth A. Barrett
  • Employees 234
UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases. It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution. The company's lead product candidate is UGN-102, which is in Phase III clinical trials for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer. It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer. The company has a license agreement with Allergan Pharmaceuticals International Limited for developing and commercializing pharmaceutical products that contain RTGel and clostridial toxins; Agenus Inc. to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for high-grade bladder cancer. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.