BioPharmSignal logoBioPharmSignal

Biotech News

UroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC

UroGen Pharma (URGN)UroGen PharmaFDA / regulatory

PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by

Related news

URGNUroGen Pharma2026-07-15 12:00 EST

UroGen Receives New U.S. Patent Allowance Expected to Provide Protection into July 2044 for ZUSDURI™ and UGN-103

URGNUroGen Pharma2026-08-05 12:00 EST

UroGen Reports $50.4 Million of ZUSDURI Revenue and Provides Second Quarter 2026 Financial Results and Highlights

BMYBMYBristol-Myers Squibb Company2026-08-13 21:12 EST

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

REPLReplimune Group2026-08-06 20:00 EST

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

MGNXMacroGenics2026-06-22 20:43 EST

MacroGenics to Receive Milestone Payment from Sanofi for Recent TZIELD® Approval

REGNRegeneron Pharmaceuticals2026-08-19 17:58 EST

Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP)

REPLReplimune Group2026-07-30 22:15 EST

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

RVMDRevolution Medicines2026-07-22 20:05 EST

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

BMYBMYBristol-Myers Squibb Company2026-07-13 10:59 EST

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

ELVNEnliven Therapeutics2026-06-11 12:00 EST

Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

View all latest news

UroGen Pharma

Uro-Oncology Franchise UroGen Pharma develops and commercializes treatments for urothelial and other specialty cancers. Its approach combines local drug delivery with formulations intended to extend exposure within the urinary tract and provide non-surgical alternatives for patients with recurrent disease. Commercial ZUSDURI...

Recent company news

URGNUroGen Pharma2026-08-20 11:00 EST

UroGen Announces Strategic Collaboration and Investment Agreements with IntraGel to Access Biodegradable Sustained-Release Gel Platform and Expand Oncology Pipeline

URGNUroGen Pharma2026-08-17 12:00 EST

UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC

URGNUroGen Pharma2026-08-05 12:00 EST

UroGen Reports $50.4 Million of ZUSDURI Revenue and Provides Second Quarter 2026 Financial Results and Highlights

URGNUroGen Pharma2026-07-29 12:00 EST

UroGen Pharma to Report Second Quarter 2026 Financial Results on Wednesday, August 5th, 2026

URGNUroGen Pharma2026-07-15 12:00 EST

UroGen Receives New U.S. Patent Allowance Expected to Provide Protection into July 2044 for ZUSDURI™ and UGN-103

Stock data

Close
46.86 USD
Market cap
1.29B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States