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.

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.