UroGen’s Zusduri approval validates FDA’s flexibility, says D. Boral

D. Boral Capital analyst Jason Kolbert reiterated a Buy rating and $25 price target on UroGen Pharma (URGN) after the company received FDA approval for Zusduri for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, marking a “surprising” regulatory outcome given last month’s narrow 5-4 ODAC vote against its benefit-risk profile. The approval validates the agency’s willingness to exercise flexibility in high-unmet-need indications, despite divided advisory input, the analyst tells investors in a research note.