Urogen Pharma Soars 18.34% on Positive Clinical Trial Data

Urogen Pharma's stock surged by 18.34% in pre-market trading on April 28, 2025, driven by positive clinical trial data and regulatory updates.

Urogen Pharma recently presented updated data from the Phase 3 ENVISION trial of UGN-102, an investigational treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated an 80.6% duration of response (DOR) at 18 months in patients who achieved a complete response at three months. This data was unveiled during a podium presentation at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada.

The ENVISION trial's findings highlight UGN-102's potential to offer a non-surgical treatment option for LG-IR-NMIBC patients, who often face repeated surgeries and associated risks. The trial's results showed that UGN-102 did not adversely impact the quality of life while achieving high response rates. This is significant as the current standard of care, transurethral resection of bladder tumor (TURBT), can be invasive and impact patients' physical health and quality of life.

UroGen Pharma has also completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102, with a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025. The company's proprietary RTGel technology, which enables longer exposure of bladder tissue to mitomycin, is a key factor in the potential success of UGN-102.