UroGen Pharma Ltd. (URGN) announced that post‑hoc analyses from its Phase 3 ENVISION trial will be presented at the 2026 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO‑GU 2026) scheduled for February 26‑28, 2026. The analyses break down complete response (CR) rates by European Organization for Research and Treatment of Cancer (EORTC) recurrence score groups in patients with recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer (LG‑IR‑NMIBC).
The data show CR rates at three months of 83.9% for low‑risk (EORTC 1‑4), 81.2% for intermediate‑risk (EORTC 5‑9), and 60.0% for high‑risk (EORTC 10‑17) patients. Across all patients, the overall CR rate was 79.6% at three months. While the specific 24‑month recurrence‑free probabilities by EORTC group were not directly corroborated, the overall durability of response at 24 months was 72.2%, indicating that the majority of responders remained event‑free two years after achieving a complete response.
The permanent J‑code (J9282) for ZUSDURI became effective on January 1, 2026. Liz Barrett, President and CEO of UroGen, said, "With the permanent J Code now in effect for ZUSDURI, providers have a clearer, more efficient path to securing reimbursement, which in turn facilitates patient access to ZUSDURI without unnecessary administrative hurdles. This is a meaningful step toward more reliable, predictable access to an important therapy for those navigating this highly recurrent disease." The J‑code is expected to streamline billing and reimbursement across community urology practices, accelerating adoption of the therapy.
The U.S. low‑grade NMIBC patient population is estimated at 82,000 individuals. ZUSDURI’s robust efficacy across all EORTC risk categories positions it as a first‑in‑class, non‑surgical treatment option that could capture a larger share of this market. The combination of strong clinical data and an operational milestone that simplifies reimbursement enhances the drug’s commercial potential and could translate into significant revenue upside as community uptake increases.
Sandip Prasad, MD, M.Phil, Director of Urology at Morristown Medical Center and principal investigator of the ENVISION trial, noted, "These data demonstrate that treatment with UGN‑102 results in a clinically meaningful CR rate and that the durability of the response in patients with LG‑IR‑NMIBC is robust." He added, "This latest update from the pivotal ENVISION trial of Zusduri showed that, among patients who achieved a complete response at three months, the probability of remaining event‑free 24 months after complete response was 72.2%."
The post‑hoc analyses reinforce ZUSDURI’s clinical value proposition and support UroGen’s strategy to accelerate adoption in community settings. The data demonstrate that the therapy delivers durable complete responses across low‑, intermediate‑, and high‑risk groups, strengthening its position as a standard of care for LG‑IR‑NMIBC and underscoring the commercial opportunity presented by the newly effective J‑code.
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