Will the FDA approve UroGen Pharma's UGN-103 for low-grade intermediate-risk non-muscle invasive bladder cancer by June 28, 2027?
deadline 2027-06-28
confidence medium
tier 4 evidence
90%Asturna estimate
Resolution criterion
Yes if the FDA approves UGN-103 for the indication stated above (Drugs@FDA entry, FDA announcement or UroGen Pharma press release) no later than June 28, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of November 5, 2026: according to the UroGen Pharma filing of November 4, 2026, the FDA has set a PDUFA target action date of June 14, 2027. Source: https://www.sec.gov/Archives/edgar/data/1668243/000143774926034769/ex_1036873.htm
What pushes it up
- FDA has set a PDUFA target action date of 14 June 2027, which is before the 28 June 2027 deadline – official filing [tier 1]
What pushes it down
- Only tier‑4 press reports of NDA acceptance; no confirmed approval yet and FDA can issue a complete response letter or extend the PDUFA date – historical miss‑rate of PDUFA dates
What would move this number most
Whether the FDA will issue a complete response letter or extend the PDUFA date before 28 June 2027
How this number is built
| Deadline | 2027-06-28 |
| Base rate | 87% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 79 · 90 · 92 (spread 13 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-11-05 19:51 |
| Model | openai/gpt-oss-120b (Groq) |