HC Wainwright & Co. analyst Raghuram Selvaraju downgraded the rating on UroGen Pharma Ltd. (NASDAQ:URGN) from Buy to Neutral.

Selvaraju points out that the FDA’s Oncologic Drugs Advisory Committee voted 5-4 against the benefit-risk profile of UroGen’s investigational therapy UGN-102 (mitomycin for intravesical solution), intended for patients with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).

According to the analyst, the narrow negative vote significantly lowers the likelihood of UGN-102 receiving timely approval.

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Selvaraju notes that if UGN-102 does receive FDA approval next month -- with the only condition being a post-marketing randomized, controlled trial -- this scenario would warrant a reassessment of their current rating on the stock.

Selvaraju notes that UroGen concluded the first quarter of 2025 with approximately $200 million in cash, cash equivalents and marketable securities.

According to the analyst, this financial position should be adequate to sustain operations through late 2026, even if UGN-102 fails to secure regulatory approval.

For 2026, the analyst now forecasts a net loss of $2.14 per share, a notable shift from his earlier projection of 27 cents in earnings for the year.

Selvaraju highlights that UroGen is advancing development on UGN-103 and UGN-104, next-generation mitomycin-based formulations for UGN-102 and JELMYTO, respectively.

These candidates combine the company’s RTGel delivery platform with a novel mitomycin formulation licensed from medac GmbH.

The Phase 3 UTOPIA trial evaluating UGN-103 in patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer is currently enrolling.

Selvaraju anticipates that enrollment will wrap up by mid-2025, with top-line data expected shortly after. If results are positive, a regulatory submission could occur in 2026, potentially leading to FDA approval by 2027.

URGN Price Action: Urogen shares closed at $4.19 on Friday.

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