UroGen Surges on Updated Late-Stage Data for Bladder Cancer Therapy

Reno, Nevada (UroToday.com) -- UroGen Pharma (NASDAQ:URGN) announced Thursday that its Phase 3 ENVISION trial for bladder cancer therapy UGN-102 (mitomycin), which had previously reached the primary endpoint, indicated a nearly 82% duration of response at 12 months.

After a brief trading halt, URGN shares climbed ~50% in reaction.

The finding, based on a statistical measure known as the Kaplan-Meier estimate, represented patients who achieved complete remission three months after starting the therapy.

Additional data for 15 and 18 months suggest approximately 80% duration of response based on the same metric.

ENVISION is a single-arm global trial designed to evaluate UGN-102 in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

There were no new safety signals, and urinary tract infection and fatigue were among the most commonly cited treatment-emergent adverse events.

The company is currently submitting its marketing application for UGN-102 to the FDA on a rolling basis. It intends to complete the submission in Q3 2024 and expects a potential approval in Q1 2025.

Source: Seeking Alpha. (2024). UroGen Surges on Updated Late-Stage Data for Bladder Cancer Therapy [Press release]. https://seekingalpha.com/news/4115698-urogen-stock-surges-bladder-cancer-data?mailingid=35704918&messageid=2900&serial=35704918.261&source=email_2900&utm_campaign=rta-stock-news&utm_content=link-1&utm_medium=email&utm_source=seeking_alpha&utm_term=35704918.261.