UroGen posts $50.4 million ZUSDURI revenue, cites patent allowance and pipeline progress
UroGen reported second-quarter ZUSDURI sales up 73% from the prior quarter and outlined next steps for UGN-103, UGN-104 and UGN-501, alongside a Teva patent settlement on JELMYTO.
UroGen Pharma reported second quarter 2026 results on August 5, 2026, including ZUSDURI net product revenue of $50.4 million, up 73% from the first quarter of 2026.1 As of June 30, 2026, the company said it had 1,444 activated sites of care, 452 unique ZUSDURI prescribers, and 204 repeat prescribers, representing about 45% of total prescribers, up from 40% in the first quarter.1
On the clinical side, updated Phase 3 ENVISION data showed that among patients with a complete response at three months (79.6%), the 36-month duration of response reached 64.5% (95% CI: 54.6, 72.8) by Kaplan-Meier estimate1, with a median follow-up of 35.5 months and median duration of response not yet reached.1
The company also disclosed a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering treatment of recurrent low-grade intermediate-risk NMIBC without TURBT, expected to provide protection into July 2044 once issued, covering both ZUSDURI and UGN-103.1
On pipeline timing, UroGen remains on track to submit an NDA for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027.1 The company said it plans to start a randomized controlled Phase 3 trial of UGN-103 in high-risk NMIBC patients in the second half of 2026, followed by a separate trial testing UGN-103 as adjuvant therapy for newly diagnosed intermediate-risk patients in 2027, according to the release. Separately, the FDA has cleared the IND for UGN-501, and UroGen said it intends to start that Phase 1 NMIBC trial in the fourth quarter of 2026.
On litigation, UroGen said it settled patent litigation with Teva over a generic JELMYTO ANDA, granting Teva a non-exclusive license to sell its generic starting September 15, 2030, if FDA-approved.1
The company reported cash, cash equivalents and marketable securities of $108.0 million as of June 30, 20261, and raised its full-year 2026 operating expense guidance to $260 million to $270 million, including $20 million to $24 million in non-cash share-based compensation.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.