Nick [on behalf of Tara]'s questions to Urogen Pharma Ltd (URGN) leadership • Q4 2024
Question
An analyst asked if UGN-102 could be used off-label for the 10% of treatment-naive patients ineligible for surgery, given the anticipated approval is for the recurrent setting.
Answer
President and CEO Liz Barrett confirmed such use would be off-label and not promoted by UroGen. She explained that reimbursement would depend on physicians working with payers. Barrett emphasized that this does not alter their revenue projections of over $1 billion for UGN-102 and that aligning with the FDA on the recurrent population for the ODAC meeting was a strategic decision to ensure a focused discussion and avoid a potential negative vote.