Bensalem, Pa.– A class action lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN), alleging securities fraud related to the company’s handling of its drug candidate UGN-102. The suit, filed on behalf of investors who purchased shares between July 27, 2023, and May 15, 2025, comes in the wake of significant regulatory setbacks that led to steep declines in the company’s stock price.
The Law Offices of Howard G. Smith is encouraging affected shareholders to contact the firm ahead of the July 28, 2025 deadline to seek appointment as lead plaintiff in the case. The complaint centers on allegations that UroGen misled investors about the design and regulatory prospects of its Phase III ENVISION clinical trial for UGN-102, an investigational treatment for non-muscle invasive bladder cancer.
The controversy began on May 16, 2025, when the U.S. Food and Drug Administration (FDA) released a briefing document ahead of a scheduled advisory committee meeting. In the document, the agency raised serious concerns about UGN-102’s clinical data, specifically criticizing the absence of a concurrent control group in the ENVISION study. The FDA stated that the lack of proper trial design made it difficult to determine whether the drug was responsible for the treatment outcomes and indicated that it had previously advised UroGen to conduct a randomized trial.
Following the FDA’s remarks, UroGen’s stock dropped 25.8%, falling $2.54 to close at $7.31 per share. Days later, on May 21, the FDA’s Oncologic Drugs Advisory Committee voted against recommending approval of UGN-102, citing an unfavorable benefit-risk profile for patients with recurrent low-grade, intermediate-risk bladder cancer. This led to a further 44.7% decline in UroGen’s stock, which closed at $4.17 per share.
According to the lawsuit, UroGen and its executives failed to disclose material information about the risks associated with the ENVISION study design and the likelihood of FDA rejection. The complaint alleges that the company ignored repeated warnings from the FDA about the inadequacy of the study’s endpoints and trial structure, which ultimately undermined the new drug application and misled investors about the drug’s chances for approval.
