Sign in

    Kelsey Goodwin • Guggenheim Securities, LLC

    Kelsey Goodwin's questions to Urogen Pharma Ltd (URGN) leadership

    Kelsey Goodwin's questions to Urogen Pharma Ltd (URGN) leadership • Q1 2025

    Question

    Kelsey Goodwin asked about the company's preparations for the upcoming ODAC meeting, where they anticipate the most pushback, and what they consider their strongest counterarguments.

    Answer

    CEO Liz Barrett detailed extensive preparations, including multiple mock ODAC panels. She believes the main challenge will be contextualizing the data from the single-arm ENVISION study. Chief Medical Officer Dr. Mark Schoenberg highlighted their strongest arguments: the remarkable efficacy in a recurrent population (80% CR, >80% durability at 18 months), a favorable safety profile, and the support of two highly credible Key Opinion Leaders (KOLs) who will be presenting.

    Ask Fintool Equity Research AI

    Kelsey Goodwin's questions to Urogen Pharma Ltd (URGN) leadership • Q3 2024

    Question

    Kelsey Goodwin asked about the expected timing for FDA notification of an ODAC meeting and the potential impact of the initial miscellaneous J-code on UGN-102's launch uptake.

    Answer

    President and CEO Liz Barrett anticipates an ODAC in the April-May 2025 timeframe and expects to receive notification by February or March. CCO David Lin and CEO Liz Barrett explained that while the miscellaneous J-code might cause some initial hesitation in community settings, they will provide robust reimbursement support, and expect initial uptake to be strong in hospitals, similar to the JELMYTO launch experience.

    Ask Fintool Equity Research AI