Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Approved · ActiveModality: Mitomycin formulated with RTGel sustained-release hydrogel
Aliases mitomycin for pyelocalyceal solution (formerly UGN-101)
Target DNA
Indications
Low-grade upper tract urothelial cancer (low-grade UTUC)(Approved)
Status note FDA approved April 15, 2020 for adults with low-grade upper tract urothelial cancer. Teva settlement (June 2026): non-exclusive license to Teva's generic beginning September 15, 2030 if approved.
Zusduri
Approved · ActiveModality: Mitomycin formulated with RTGel sustained-release hydrogel (intravesical)
Aliases mitomycin for intravesical solution (formerly UGN-102)
Partnerships medac Gesellschaft für klinische Spezialpräparate (Jan 2024 licensing and supply agreement): next-generation formulation of Zusduri combining medac's proprietary mitomycin formulation with UroGen's RTGel technology
Status note Next-generation investigational formulation of Zusduri. Phase 3 UTOPIA trial enrollment completed July 2025. FDA agreed on a regulatory plan to submit an NDA based on UTOPIA data.
Partnerships medac (Jan 2024 licensing and supply agreement): next-generation formulation of Jelmyto
Indications
Low-grade UTUC(Phase 3)
Catalysts
— 2026 (end)
Status note Next-generation investigational formulation of Jelmyto. FDA accepted IND February 2025; Phase 3 trial in low-grade UTUC initiated June 2025.
Partnerships IconOVir Bio (Feb 2025 asset purchase agreement): acquired ICVB-1042 and related IP/regulatory assets
Indications
NMIBC (locally administered)(Phase 1)
Catalysts
— 2026 (Q4)
Status note Investigational oncolytic virus therapy. FDA cleared IND July 2026; initial focus bladder cancer with potential expansion beyond the genitourinary system.
UGN-301
Phase 1 · TerminatedModality: Anti-CTLA-4 monoclonal antibody with RTGel
Aliases zalifrelimab (AGEN1884, anti-CTLA-4 formulated with RTGel)
Target CTLA-4
Status note Was in Phase 1 development for high-grade NMIBC. In November 2025 the company notified Agenus of termination of the license agreement in connection with its decision to discontinue development of UGN-301.
Per-asset detail extracted from the 10-Q filed 2026-08-05. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Sponsor-matched active trials from ClinicalTrials.gov (5 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.
Institutional holder positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.
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