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Law Offices of Howard G. Smith Encourages UroGen Pharma Ltd.

1. UroGen faces class action lawsuit for investor losses during Class Period. 2. FDA expressed doubts about UGN-102's efficacy due to study design flaws. 3. UGN-102 NDA was voted against by Oncologic Drugs Advisory Committee. 4. Stock price dropped significantly after FDA and committee announcements. 5. Defendants allegedly misled investors regarding UroGen's drug efficacy and risks.

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FAQ

Why Very Bearish?

The consistent decline in stock price after negative FDA news indicates severe investor loss of confidence, often resulting in a bearish market outlook. Historical incidents, such as those with other biotech companies facing similar FDA rejections, show significant downturns in stock performance.

How important is it?

The lawsuit stems from substantial negative asset developments, likely to significantly impact URGN's stock in near-term trading.

Why Short Term?

Immediate impact from recent FDA news and lawsuit developments will likely overshadow long-term performance, similar to past market reactions in similar contexts.

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BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) 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. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN UROGEN PHARMA LTD. (URGN), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PARTICIPATE IN THE ONGOING SECURITIES FRAUD LAWSUIT. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@howardsmithlaw.com, by telephone at (215) 638-4847 or visit our website at www.howardsmithlaw.com. What Happened? On May 16, 2025, before the market opened, the U.S. Food and Drug Administration (“FDA”) published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen’s new drug application (“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 [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 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, on unusually heavy trading volume. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found 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, on unusually heavy trading volume. What Is The Lawsuit About? The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. Contact Us To Participate or Learn More: If you purchased UroGen securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, Telephone: (215) 638-4847 Email: howardsmith@howardsmithlaw.com, Visit our website at: www.howardsmithlaw.com. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. More News From Law Offices of Howard G. Smith

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