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.
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.
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