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LOS ANGELES, May 29, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises UroGen Pharma Ltd. ("UroGen " or the "Company") (NASDAQ: URGN) investors of a class action representing investors that bought securities between July 27, 2023 and May 15, 2025, inclusive (the "Class Period"). UroGen investors have until July 28, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
On May 16, 2025, prior to the market opening, the U.S. Food and Drug Administration (“FDA”) released a briefing document ahead of an upcoming meeting of its Oncologic Drugs Advisory Committee regarding UroGen Pharma Ltd.’s New Drug Application (“NDA”) for UGN-102. In the document, the FDA expressed concerns about the adequacy of the submitted data to support a conclusion that UGN-102 was effective. Specifically, the agency noted that “[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret.” The FDA further stated that 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.”
Following the publication of the briefing document, UroGen’s stock price declined $2.54, or approximately 25.8%, to close at $7.31 per share on May 16, 2025, on unusually high trading volume.
Subsequently, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102. The committee concluded that the overall benefit-risk profile of UGN-102 (intravesical mitomycin) was not favorable for patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.
Following this announcement, UroGen’s stock price fell an additional $3.37, or 44.7%, closing at $4.17 per share on May 21, 2025, again on unusually heavy trading volume.
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