The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) securities during the period from July 27, 2023, through May 15, 2025 (“the Class Period”). Investors have until July 28, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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UroGen is a biopharmaceutical company focused on the development and commercialization of solutions for urothelial and specialty cancers. One of its lead product candidates, UGN-102, is a treatment for low-grade, intermediate-risk invasive bladder cancer. UGN-103 is currently in phase 3 of clinical trials (“ENVISION”).

On May 16, 2025, the Federal Drug Administration (“FDA”) released a briefing document in advance of an Oncologic Drugs Advisory Committee meeting on May 21 to discuss a New Drug Application (“NDA”) for UGN-102. In the briefing, the FDA stated: “Given that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (“CR”) and duration of response (“DOR”) are difficult to interpret. While CR indicates drug activity of UGN-102, it is unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease.” Moreover, the FDA questioned the long-term benefits of UGN-102, noting a lack of data on future treatments and its potential to reduce the frequency of transurethral resection of bladder tumor procedures in certain patient populations. The FDA also said it had “recommended a randomized trial design to the Applicant several times during their product’s development due to concerns with interpreting efficacy results” but UroGen “chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.” On this news, the price of UroGen fell $2.54 per share, or approximately 26%, from $9.85 per share on May 15, 2025, to close at $7.31 on May 16, 2025.

Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen’s stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume.

The complaint alleges that defendants, throughout the Class Period, failed to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA’s warnings about the study design used to support a drug application for UGN-102; and (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved.

If you purchased or otherwise acquired UroGen securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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