Will the FDA grant accelerated approval to povetacicept in IgA nephropathy before 15 December 2026?
deadline 2026-12-15
confidence high
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 BLA by 15 December 2026 (Drugs@FDA or the Vertex newsroom). A complete response letter, a postponement of the PDUFA date, or the absence of a decision by that date count as no.
Verified starting state
BLA accepted for accelerated approval, PDUFA date 30 November 2026, on the basis of proteinuria reduction. The BAFF/APRIL inhibitor class is crowding into this indication and the FDA has tightened its requirements on biomarker-based accelerated approvals. (1 June 2026)
What pushes it up
- BLA acceptance for accelerated approval with a PDUFA date of 30 Nov 2026 indicates likely approval before deadline [tier 1]
What pushes it down
- FDA has tightened requirements on biomarker-based accelerated approvals, which could delay decision [tier 1]
- Crowding of BAFF/APRIL inhibitors in IgA nephropathy may increase regulatory scrutiny [tier 1]
What would move this number most
Whether the FDA's tightened biomarker criteria will cause a delay beyond the PDUFA date
How this number is built
| Deadline | 2026-12-15 |
| Base rate | 64% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 72 · 72 (spread 0 pts) |
| Confidence | high |
| Evidence cap | applied: 78% brought back to 72% |
| Last revised | 2026-09-21 22:24 |
| Model | openai/gpt-oss-120b (Groq) |
Probability history
2026-09-21 22:24 72% 8 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 07:34 78% 6 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).