FDA Approves First Non-Surgical Treatment for Non-Muscle Invasive Bladder Cancer
The FDA approved UroGen Pharma's Zusduri as the first drug to treat non-muscle invasive bladder cancer that hasn't spread beyond the inner layers of the organ.
FDA Advisory Committee Rejects UroGen's Bladder Cancer Therapy UGN-102
UroGen Pharma's stock plummeted approximately 47% after an FDA advisory committee voted against its bladder cancer therapy UGN-102 (mitomycin), citing concerns over study design.
UroGen's UGN-102 Nears FDA Approval with Impressive Phase 3 Results for Bladder Cancer
• UroGen Pharma has submitted a new drug application for UGN-102 ahead of schedule, with FDA review underway and a target decision date of June 13, 2025. • The Envision Phase 3 trial demonstrated exceptional efficacy with UGN-102 achieving a 79.6% complete response rate at 3 months and 82.3% duration of response at 12 months in bladder cancer patients. • Despite reporting a $126.9 million net loss for 2024, UroGen maintains a strong balance sheet with $241.7 million in cash and is expanding its sales force from 52 to 83 representatives in preparation for commercial launch.
UroGen's UGN-102 Shows Promise in Bladder Cancer Treatment, Awaits FDA Decision
• UroGen Pharma's UGN-102 New Drug Application has been accepted by the FDA, with a decision expected by June 13, 2025. • The ENVISION Phase 3 trial data highlights a 79.6% complete response rate at three months and an 82.3% durability of response at 12 months. • UGN-102, a mitomycin-based intravesical solution, could become the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. • The UTOPIA Phase 3 trial for UGN-103, targeting recurrent LG-IR-NMIBC, has commenced, expanding UroGen's pipeline.
Phase I Trial Investigates Zalifrelimab (UGN-301) Alone and in Combination for Recurrent NMIBC
• A Phase I dose-escalation study is evaluating UGN-301 (zalifrelimab) as monotherapy and in combination with UGN-201 or gemcitabine for recurrent non-muscle invasive bladder cancer (NMIBC). • The study aims to determine the biologically effective dose and recommended Phase II dose of UGN-301, assessing safety, tolerability, and preliminary efficacy. • Key endpoints include the incidence of treatment-emergent adverse events, dose-limiting toxicities, and complete response rate in patients with carcinoma in situ (CIS). • Recruitment is ongoing for this multi-part trial, which includes patients with high-grade or intermediate-risk NMIBC who have failed prior BCG therapy.
UGN-102 Demonstrates Durable Response in Recurrent Low-Grade Bladder Cancer
• UroGen Pharma's UGN-102 shows an 82.3% duration of response at 12 months in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). • The Phase 3 ENVISION trial highlights a 79.6% complete response rate at 3 months following the initial UGN-102 instillation, indicating a promising treatment for LG-IR-NMIBC. • UGN-102's safety profile remains consistent with previous trials, reinforcing its potential as a valuable option for patients facing repeated surgical interventions. • The FDA has set a PDUFA goal date of June 13, 2025, for UGN-102, potentially marking it as the first FDA-approved treatment for LG-IR-NMIBC.
JELMYTO Demonstrates Durable Response in Low-Grade Upper Tract Urothelial Cancer
Jelmyto (mitomycin) shows sustained recurrence-free survival at three years in patients with low-grade upper tract urothelial cancer (LG-UTUC).
UroGen Pharma Advances Bladder Cancer Pipeline with UGN-102 and UGN-103
• UroGen Pharma's New Drug Application for UGN-102, a treatment for non-muscle invasive bladder cancer, has been accepted by the FDA, with potential launch in 2025. • JELMYTO, UroGen's existing product, achieved $25.2 million in net sales in Q3, marking an increase from the previous year due to strong demand. • A Phase 3 trial has been initiated for UGN-103, a next-generation formulation for bladder cancer, accompanied by a Notice of Allowance for a related patent. • Despite progress, UroGen reported a net loss of $23.7 million in Q3 due to increased R&D and administrative expenses, while holding $254.2 million in cash and securities.
UroGen's UGN-102 Receives FDA Acceptance for Bladder Cancer Treatment
• UroGen Pharma's New Drug Application for UGN-102 has been accepted by the FDA, with a PDUFA target action date set for June 13, 2025. • UGN-102 is intended for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). • Phase 3 ENVISION trial data showed a 79.6% complete response rate at three months and an 82.3% duration of response at 12 months. • JELMYTO, UroGen's existing product, achieved $25.2 million in net product sales in Q3 2024, marking a growth from the previous year.
UroGen's UGN-102 Shows Promise for Non-Muscle Invasive Bladder Cancer
• UroGen's New Drug Application for UGN-102 has been accepted by the FDA, with a PDUFA target action date set for June 13, 2025. • Phase 3 ENVISION trial data showed a 79.6% complete response rate at three months and an 82.3% duration of response at 12 months with UGN-102. • UroGen is also advancing UGN-103, a next-generation mitomycin formulation, with a Phase 3 trial underway and plans for a UGN-104 study in LG-UTUC. • JELMYTO, UroGen's existing product, generated $25.2 million in Q3 2024 revenue, driven by strong demand growth.