Will the FDA approve Agios's mitapivat for sickle cell disease by November 15, 2026?
deadline 2026-11-15
confidence medium
tier 4 evidence
86%PolySignal estimate
Resolution criterion
Yes if the FDA approves mitapivat for the indication stated above (Drugs@FDA entry, FDA announcement or Agios press release) no later than November 15, 2026. 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 October 12, 2026: according to the Agios filing of July 30, 2026, the FDA has set a PDUFA target action date of November 1, 2026. Source: https://www.sec.gov/Archives/edgar/data/1439222/000143922226000115/agio-73026xfyxex991earning.htm
What pushes it up
- FDA set a PDUFA target action date of November 1, 2026, indicating a decision is expected before the November 15 deadline [tier 1]
- FDA granted priority review to the mitapivat sNDA, which typically accelerates the review timeline [tier 4]
What pushes it down
- FDA may extend the PDUFA target date or issue a complete response letter, which would delay approval beyond the deadline [tier 1]
- Only tier‑4 press reports confirm the priority review; no official approval announcement yet, reflecting uncertainty [tier 4]
What would move this number most
Whether the FDA meets the PDUFA target date of Nov 1 2026 or issues an extension/CRL.
How this number is built
| Deadline | 2026-11-15 |
| Base rate | 87% |
| Best evidence | tier 4 · 4 article(s) used |
| Independent runs | 82 · 90 (spread 8 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-12 16:32 |
| Model | openai/gpt-oss-120b (Groq) |
Sources consulted