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%Asturna 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
- The FDA established a PDUFA target action date of November 1, 2026, which falls comfortably before the November 15, 2026 deadline [tier 1].
- Mitapivat already has an established regulatory and safety history as an approved drug (Pyrukynd), reducing novelty risks in the application [tier 1].
- No late-cycle review extensions, complete response letters, or advisory committee hurdles have been reported as of October 18, 2026 [tier 1].
What pushes it down
- A standard first-cycle failure or delay rate of approximately 13% applies to standard review cohorts [tier 1].
- The FDA can issue a last-minute three-month PDUFA extension upon submission of additional major data analyses, which would move the decision past the November 15 deadline [tier 1].
What would move this number most
Whether the FDA issues a standard three-month PDUFA review extension or a Complete Response Letter (CRL) prior to or on November 1, 2026.
How this number is built
| Deadline | 2026-11-15 |
| Base rate | 87% |
| Best evidence | tier 4 · 0 article(s) used |
| Independent runs | 85 · 86 (spread 1 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-18 09:03 |
| Model | gemini-3.7-flash |
Probability history
2026-10-18 09:03 86% 35 article(s) on file · gemini-3.7-flash
- What pushes it up. The FDA established a PDUFA target action date of November 1, 2026, which falls comfortably before the November 15, 2026 deadline [tier 1].
- What pushes it up. Mitapivat already has an established regulatory and safety history as an approved drug (Pyrukynd), reducing novelty risks in the application [tier 1].
- What pushes it up. No late-cycle review extensions, complete response letters, or advisory committee hurdles have been reported as of October 18, 2026 [tier 1].
- What pushes it down. A standard first-cycle failure or delay rate of approximately 13% applies to standard review cohorts [tier 1].
- What pushes it down. The FDA can issue a last-minute three-month PDUFA extension upon submission of additional major data analyses, which would move the decision past the November 15 deadline [tier 1].
- What would move this number most. Whether the FDA issues a standard three-month PDUFA review extension or a Complete Response Letter (CRL) prior to or on November 1, 2026.
2026-10-17 09:05 89% 29 article(s) on file · gemini-3-flash-preview
- What pushes it up. The FDA has set a PDUFA target action date of November 1, 2026, which falls two weeks before the resolution deadline [1].
- What pushes it up. The FDA's launch of the Rare Disease Innovation Hub and the Rare Disease Framework Initiative in October 2026 signals a supportive regulatory environment for treatments of rare conditions like sickle cell disease [1].
- What pushes it up. Mitapivat is already an FDA-approved drug for pyruvate kinase deficiency, meaning its safety profile and mechanism of action are already established with the agency [1].
- What pushes it down. FAERS data includes 129 serious reports for mitapivat, which, while qualitative, represents a safety context the FDA must evaluate for the new indication [Context].
- What pushes it down. There is always a residual risk of a Complete Response Letter (CRL) or a PDUFA extension beyond the November 15 deadline due to manufacturing or clinical data queries [Base Rate].
- What would move this number most. The primary uncertainty is whether any late-cycle clinical or manufacturing issues emerge that could prompt the FDA to issue a Complete Response Letter or extend the review period beyond the November 15 deadline.
2026-10-16 12:01 84% 29 article(s) on file · gemini-3.8-flash
- What pushes it up. The FDA assigned a PDUFA target action date of November 1, 2026, which falls cleanly before the November 15, 2026 deadline [tier 1].
- What pushes it up. With only two weeks remaining before the PDUFA date as of mid-October 2026, no standard 3-month review extension or advisory committee hurdles have been reported [tier 1].
- What pushes it down. Any late request for major data amendments triggering a standard three-month PDUFA extension would push the decision to February 2027, resolving the question as No [tier 1].
- What pushes it down. A Complete Response Letter (CRL) due to safety signals, manufacturing inspection issues, or efficacy shortfall remains a non-zero risk in FDA reviews [tier 1].
- What would move this number most. Whether the FDA issues a standard 3-month PDUFA extension or a Complete Response Letter before the target action date.
2026-10-12 16:32 86% 6 article(s) on file · openai/gpt-oss-120b (Groq)
- 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]
- What pushes it up. 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]
- What pushes it down. 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.