SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) -- Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025. UroGen engages in the development and commercialization of solutions for specialty cancers. The Company’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer.

For more information, submit a form, email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.

The Allegations: Robbins LLP is Investigating Allegations that UroGen Pharma Ltd. (URGN) Failed to Conduct a Proper Trial for its Lead Drug Candidate

According to the complaint, the Company completed the submission of the rolling new drug application (“NDA”) for UGN-102 on August 14, 2024.

The complaint 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 the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: “[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.” 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, UroGen’s stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025.

The complaint further alleges that on May 21, 2025, the Oncological Drugs Advisory Committee voted against approving the UGN-102 NDA, finding 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.

Plaintiff contends that during the class period defendants 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.

What Now: You may be eligible to participate in the class action against UroGen Pharma Ltd. Shareholders who want to serve as lead plaintiff for the class are required to file their motion for lead plaintiff by July 28, 2025. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.  

About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002.

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