Monitor FDA review progress and any advisory committee meeting announcements ahead of the June 14, 2027 PDUFA date. The UTOPIA trial's single-arm design may raise regulatory scrutiny; watch for FDA briefing documents or AdCom vote.
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Executive Summary
UroGen Pharma announced FDA acceptance of its NDA for UGN-103 (mitomycin) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, with a PDUFA target action date of June 14, 2027. The NDA is supported by Phase 3 UTOPIA trial data showing a 77.8% complete response rate at three months and 94.5% six-month event-free probability. This is a procedural milestone that advances the pipeline but does not guarantee approval.
Key Facts
- FDA accepted NDA for UGN-103 (mitomycin) for recurrent LG-IR-NMIBC
- PDUFA target action date set for June 14, 2027
- Phase 3 UTOPIA trial: 77.8% CR rate at 3 months, 94.5% event-free probability at 6 months
- UGN-103 builds on ZUSDURI with streamlined manufacturing and simplified reconstitution
- Intellectual property coverage expected into July 2044
- UGN-103 licensed from medac under a January 2024 agreement
Financial Impact
NDA acceptance is a procedural milestone; no financial terms disclosed. UGN-103 could extend UroGen's bladder cancer franchise if approved, but revenue impact is not quantifiable at this stage.
Risk Factors
- NDA acceptance does not guarantee approval; FDA may issue a Complete Response Letter
- Single-arm Phase 3 trial design may be insufficient for approval without confirmatory data
- Competition from existing ZUSDURI and other bladder cancer therapies
- PDUFA date could be delayed due to FDA review extensions
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3383365 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | SC 13G/A | $34.16 | awaiting T+5 | awaiting T+5 | $33.91 (−0.73%) |
Oct 19, 2026 8d ago | Press Release | $34.15 $34.23 | ▲ +0.23% | ▲ +0.38% | $33.91 (−0.70%) |
Oct 9, 2026 18d ago | 144 | $36.83 $34.56 | ▼ −6.16% | ▼ −4.20% | $33.91 (−7.93%) |
Sep 9, 2026 6w ago | Insider Cluster | $45.00 $43.04 | ▼ −4.36% | ▼ −4.02% | $33.91 (−24.64%) |
Aug 20, 2026 9w ago | 8-K | $46.80 $45.50 | ▼ −2.78% | ▼ −3.89% | $33.91 (−27.54%) |
Aug 5, 2026 11w ago | 8-K | $46.43 $49.00 | ▲ +5.54% | ▲ +5.18% | $33.91 (−26.97%) |
Jun 23, 2026 18w ago | 8-K | $35.42 $37.94 | ▲ +7.11% | ▲ +5.41% | $33.91 (−4.26%) |
Jun 2, 2026 21w ago | 8-K | $26.54 $28.18 | ▲ +6.18% | ▲ +9.14% | $33.91 (+27.77%) |
May 6, 2026 24w ago | Press Release | $26.25 $29.80 | ▲ +13.52% | ▲ +12.39% | $33.91 (+29.18%) |
Apr 29, 2026 25w ago | Press Release | $23.34 | awaiting T+5 | awaiting T+5 | $33.91 (+45.29%) |
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