UroGen to start new Phase 3 study for UGN-102; stops ATLAS enrollment

UroGen Pharma Ltd.

New single-arm Phase 3 pivotal study for UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer expected to start early 2022, enrolling ~220 patients at 90 sites.
ATLAS trial enrollment halted; patients already enrolled may remain until completion.
Company believes new study design increases regulatory success probability; NDA submission for UGN-102 remains on track for 2024.
UGN-301: non-human primate toxicity studies underway; multi-arm Phase 1 study planned early 2022 with combination approaches.

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