Drug ApprovalThe FDA's acceptance of the NDA for UGN-102 with a set PDUFA date indicates a strong likelihood of approval.
Market OpportunityUGN-102 could become the first FDA-approved medicine for the treatment of low-grade, intermediate-risk, non-invasive bladder cancer, with a target market that may be larger than $5 billion annually.
Pipeline ExpansionThe recent in-licensing transaction broadens UroGen Pharma's early-stage pipeline and creates a constellation of candidates for bladder cancer.