The Law Offices of Frank R. Cruz announces an investigation of UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) on behalf of investors concerning the Company’s possible violations of federal securities laws.

IF YOU ARE AN INVESTOR WHO LOST MONEY ON UROGEN PHARMA LTD. (URGN), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS.

What Is The Investigation About?

On May 16, 2025, the U.S. Food and Drug Administration (“FDA”) published materials in advance of its Advisory Committee meeting regarding UroGen’s drug application for its experimental bladder cancer therapy, UGN-102. The FDA questioned the efficacy and utility of UGN-102. Specifically, the FDA stated that it “does not agree with the statement that the complete response rate for UGN-102 was higher or more durable than that for Transurethral resection of bladder tumor (TURBT)” and that the Company’s claims that UGN-102 may “reduce the burden of repeated TURBTs” lacks long-term data and is unclear.

On this news, UroGen’s stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, thereby injuring investors.

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:

The Law Offices of Frank R. Cruz,

2121 Avenue of the Stars, Suite 800,

Century City, California 90067

Call us at: 310-914-5007

Email us at: info@frankcruzlaw.com

Visit our website at: www.frankcruzlaw.com.

Follow us for updates on Twitter at twitter.com/FRC_LAW.

If you inquire by email, please include your mailing address, telephone number, and number of shares purchased.

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