UroGen Pharma

Company Overview

Snapshot

Founded in April 2004 by Asher Holtzer, UroGen Pharma operates with 201–500 employees. The company has raised a total of $522.2 million across 11 funding rounds from 8 investors. In March 2026, UroGen Pharma refinanced its debt with a $250 million facility.

Business overview

UroGen Pharma is a biotech company focused on developing novel solutions for specialty cancers and urologic diseases. The company's core technology is RTGel, a proprietary sustained-release, hydrogel-based platform designed to improve the therapeutic profiles of existing drugs by enabling longer exposure of urinary tract tissue to medications. UroGen's product candidates, UGN-101 (MitoGel) and UGN-102 (VesiGel), aim to treat non-muscle-invasive urothelial cancer, including low-grade upper-tract urothelial carcinoma and bladder cancer, potentially through non-surgical means. The company operates within the Health Tech & Life Sciences sector, specifically in Pharmaceuticals, and serves markets in Europe, the United States, and Israel.

Strategic signal

In October 2024, UroGen Pharma announced that the FDA accepted its New Drug Application for UGN-102, a significant step towards potentially offering the first FDA-approved non-surgical treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. This acceptance, following the publication of positive ENVISION trial results showing an 82.3% duration of response 12 months after achieving complete response for UGN-102, signals strong clinical validation and a potential market-changing therapy for a critical unmet need in urologic oncology.

Company Intelligence Q&A

What was a significant financial event for UroGen Pharma in 2026?

In March 2026, UroGen Pharma refinanced its debt with a $250 million facility at an 8.25% rate.

What was the outcome of the ENVISION trial for UGN-102?

In October 2024, results from the ENVISION trial were published in the Journal of Urology, reporting an 82.3% duration of response 12 months after achieving complete response for UGN-102, a potential first FDA-approved non-surgical treatment for LG-IR-NMIBC.

When did UroGen Pharma receive FDA acceptance for its UGN-102 New Drug Application?

In October 2024, UroGen Pharma announced the FDA's acceptance of its New Drug Application for UGN-102.

What was the recent development regarding UGN-103 in November 2025?

In November 2025, UroGen reported a 77.8% three-month complete response rate from the Phase 3 UTOPIA Trial of UGN-103 and received FDA agreement on the NDA submission strategy for recurrent LG-IR-NMIBC based on this trial.

When did UroGen Pharma go public?

UroGen Pharma went public on NASDAQ in May 2017.