Will the FDA approve varegacestat in adult desmoid tumours before 31 May 2027?
deadline 2027-05-31
confidence medium
tier 4 evidence
72%PolySignal estimate
⚠ Evidence cap applied: the model proposed 78%, brought back to 72% for lack of sources solid enough to justify the departure from the base rate.
Resolution criterion
Yes if the FDA approves the NDA by 31 May 2027 (Drugs@FDA or an Immunome release).
Verified starting state
NDA accepted under standard review, PDUFA date 28 April 2027. The phase 3 RINGSIDE trial showed an 84% reduction in the risk of progression or death versus placebo and an objective response rate of 56% against 9%. The gamma-secretase inhibitor class carries a history of toxicity and a competitor is already approved. (8 July 2026)
What pushes it up
- NDA accepted under standard review with a PDUFA date of 28 April 2027, well before the deadline (tier 1)
- Phase 3 RINGSIDE trial shows strong efficacy (84% risk reduction, 56% ORR) (tier 1)
What pushes it down
- Gamma‑secretase inhibitor class has a history of toxicity concerns (tier 1)
- A competitor drug in the same class is already approved, potentially reducing perceived unmet need (tier 1)
What would move this number most
Whether the FDA will issue a complete response letter due to safety concerns or the existing competitor
How this number is built
| Deadline | 2027-05-31 |
| Base rate | 64% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 72 · 72 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | applied: 78% brought back to 72% |
| Last revised | 2026-09-21 22:25 |
| Model | openai/gpt-oss-120b (Groq) |
Probability history
2026-09-21 22:25 72% 3 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 13:48 80% 2 article(s) on file · gemini-3.6-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).