FDA ReviewThe UGN-102 advisory committee meeting is expected to proceed uneventfully with a positive vote outcome recommending approval, as the efficacy data is considered highly compelling.
Financial StabilityUroGen ended with $200.4M in cash, cash equivalents, and marketable securities, which are believed to be sufficient to support operations through the approval and launch of UGN-102.
Regulatory PrecedentThere is a clear regulatory precedent with UroGen's lead marketed product, JELMYTO, which employs the same active ingredient and delivery technology as UGN-102.