Clinical Trial DeficienciesDeficiencies in the pivotal ENVISION trial, such as its non-randomized, single-arm design, and early termination of the ATLAS trial have been highlighted, challenging the approval of UGN-102.
Regulatory ChallengesThe FDA may require additional clinical efficacy data from a randomized, controlled study, which could take two to three years to complete, increasing uncertainty for UGN-102's approval.
Revenue ForecastsRevised projections indicate a significant decline in revenue forecasts for 2025 and 2026 due to the expected non-approval of UGN-102.