URGN INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
If you suffered substantial losses and wish to serve as lead plaintiff of the UroGen class action lawsuit, please provide your information here:
CASE ALLEGATIONS: UroGen engages in the development and commercialization of solutions for specialty cancers. According to the complaint, UroGen's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer.
The UroGen class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) UroGen's ENVISION clinical study for UGN-102 was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (ii) as a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (iii) UroGen failed to heed the U.S. Food and Drug Administration's ('FDA') warnings about the study design used to support a new drug application ('NDA') for UGN-102; and (iv) as a result, there was a substantial risk that the NDA for UGN-102 would not be approved.
The UroGen class action lawsuit further alleges that on May 16, 2025, the FDA published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's NDA for UGN-102, which stated that '[g]iven that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret,' and that the FDA 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 stock fell nearly 26%, according to the complaint.
Then, on May 21, 2025, the UroGen class action lawsuit further alleges that the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk of the investigation therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock fell nearly 45%, according to the complaint.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired UroGen securities during the Class Period to seek appointment as lead plaintiff in the UroGen class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the UroGen class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the UroGen class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the UroGen class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:
Past results do not guarantee future outcomes.
Services may be performed by attorneys in any of our offices.
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