Urogen Pharma, Inc.

The Cancer Immunotherapy Market 2025-2029 report forecasts significant growth in immuno-oncology therapeutics, highlighting technologies like CAR-T Cells and Checkpoint Inhibitors. It offers insights into market opportunities, key players, and the impact on healthcare, aiming to guide investment and strategic decisions.

A phase I dose-escalation study of UGN-301 (Zalifrelimab) in recurrent non-muscle invasive bladder cancer (NMIBC) was presented at the 2024 SUO annual meeting. The study evaluates UGN-301 as monotherapy and in combination with other agents to determine safety and recommended phase II dose, aiming to address the high recurrence and progression rates in NMIBC.

UroGen is dedicated to enhancing treatment options for urological cancers through innovative technology, aiming to overcome treatment barriers and pioneer transformative therapies.

UroGen Pharma presented Phase 3 Envision trial results at the Society of Urologic Oncology meeting, showing UGN-102's high, durable complete response rate in recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer patients, with a 82.3% duration of response at 12 months and a consistent safety profile.

UroGen Pharma reports long-term follow-up study outcomes of JELMYTO (mitomycin) for pyelocalyceal solution, treating low-grade, upper tract urothelial cancer (LG-UTUC) in adults. 41 of 71 subjects achieved complete response, with median duration of response at 47.8 months. The JELMYTO uTRACT Registry is enrolling subjects to gather real-world data. 191 patients have been enrolled across 19 sites as of July 10.

Urogen Pharma reported Q3 2024 earnings, with FDA acceptance of UGN-102 NDA for non-muscle invasive bladder cancer, preparing for a 2025 launch. JELMYTO net sales rose to $25.2M, and $254.2M in cash/securities. Initiated Phase 3 trial for UGN-103 and received a patent allowance. Net loss of $23.7M due to increased R&D/administrative expenses. New CFO appointed, focusing on UGN-102 approval and $5B market opportunity.

PhaseV appoints Hamza Sheikh as Head of Business Development to support global expansion and enhance clinical trial optimization using causal ML.

Data from the phase 3 ENVISION trial supports potential FDA approval of UGN-102 for low-grade, intermediate-risk non–muscle-invasive bladder cancer, with a 79.6% complete response rate at 3 months. The trial is ongoing, with final completion expected in 2028.