TD remains confident in approval after UroGen briefing docs

TD Cowen keeps a Buy rating on UroGen Pharma (URGN) with a $35 price target after the FDA confirmed a panel meeting for UGN-102 will occur on May 21 and the briefing documents were released. The voting question will be: Is the overall benefit-risk of the investigational therapy UGN-102 favorable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer, the analyst tells investors in a research note. The panel will vote on favorable benefit/risk, where the acknowledgement of clear activity and consideration of other trials as supportive “is great to see,” says TD. It believes that as the ENVISION trial was not controlled, natural history will be debated as expected. TD thinks UroGen “is prepared” and remains confident in a positive vote and approval. The firm believes the briefing documents are as expected and says its thesis on UroGen Pharma is unchanged.