Confirms AGIO mitapivat sickle-cell sNDA PDUFA Nov 1, 2026 from the company PR; last-price as-of; empty Gage slot. Not a trade.

Agios (AGIO) mitapivat SCD PDUFA November 1, 2026 — missed dated event + last-price

Generated by Grok Bot research on 2026-08-31. Parallel-deep-research + native X. Treat as raw material — review before promoting into a project or thread.

Not a trade. Not a paper sleeve. No buy / sell / size. This clip files a missed dated event, confirms it against the company PR, and supplies last-price. Gage mark slot left empty for the filer.

Summary

The July 7, 2026 Agios PR confirms the listed PDUFA goal date of November 1, 2026 for the mitapivat sNDA in sickle cell disease: Priority Review, accelerated-approval pathway, confirmatory Phase 3 REIGNITE. The company frames the filing as an sNDA for mitapivat (not as a PYRUKYND-branded sNDA). That dated event was missing from the wiki entity last updated 2026-07-15. The missed SCPC/VOC co-primary is not in the July 7 PR; it is in Agios's November 19, 2025 RISE UP topline PR. Approval has not happened. No ADCOM is a wiki prior, not a sentence in the fetched July 7 PR or Q2 2026 earnings PR. Last-price: AGIO $33.32 close 2026-08-28 (Friday session; 2026-08-29 is Saturday). Gage mark: empty.

Findings

1. PDUFA November 1, 2026 — listed vs confirmed

Item	Listed (task / wiki miss)	Confirmed from primary	Verdict
PDUFA goal date	November 1, 2026	"FDA's PDUFA goal date is November 1, 2026" and "The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November 1, 2026."	Confirmed
Product / filing	mitapivat / Pyrukynd sNDA, sickle cell	sNDA for mitapivat, an oral PK activator, in sickle cell disease. PYRUKYND® is the U.S. brand for PK deficiency; AQVESME™ is the U.S. brand for thalassemia. The PR does not title this a PYRUKYND sNDA.	Confirmed as mitapivat sNDA; Pyrukynd-label on the SCD filing is company-PR-absent
Review type	Priority Review	FDA accepted the sNDA "with a Priority Review"; Priority Review shortens the target from 10 months to six.	Confirmed
Pathway	accelerated	sNDA "submitted under the FDA's accelerated approval pathway"; confirmatory trial "must be underway when the FDA makes its approval decision."	Confirmed
ADCOM	wiki: no ADCOM	July 7 PR contains zero "advisory committee" / ADCOM language. Q2 2026 earnings PR likewise has none.	Not confirmed (honest miss)
Confirmatory Phase 3	REIGNITE	"REIGNITE is the confirmatory clinical trial required to be conducted under the U.S. accelerated approval pathway." NCT07656415; ~159 patients aged ≥12; 2:1 mitapivat 100 mg BID vs placebo; primary endpoint transfusion-free status Week 4–52.	Confirmed

Primary: U.S. FDA Grants Priority Review to Agios' sNDA for Mitapivat in Sickle Cell Disease (dated Jul 07, 2026; datePublished 2026-07-07T07:01:46-0400). Fetched via curl after WebFetch timeout; HTTP 200.

The same PDUFA sentence is restated in Agios's Q2 2026 earnings PR (July 30, 2026): "The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November 1, 2026."

2. Confirm test — filing / review despite missed VOC co-primary (not approval)

Approval has not occurred. The wiki test is acceptance for Priority Review despite a missed co-primary, sometimes shortened to "approval despite missed VOC." Only the first half is on the calendar.

The July 7 PR describes RISE UP's two primaries (hemoglobin response and annualized sickle cell pain crises) but does not say the pain-crisis / VOC co-primary was missed.

That miss is in Agios's own RISE UP Phase 3 topline PR, November 19, 2025 (fetched curl HTTP 200):

Hemoglobin response (co-primary): met. 40.6% mitapivat vs 2.9% placebo, 2-sided p<0.0001. Response = ≥1.0 g/dL increase in average hemoglobin Week 24–52.
Annualized rate of SCPCs / pain crises (co-primary): missed statistical significance. 2.62 mitapivat vs 3.05 placebo, 2-sided p=0.1213. Company wording: "this trend did not achieve statistical significance."
PROMIS Fatigue key secondary: not met.

So: Priority Review of an accelerated sNDA after a missed SCPC/VOC co-primary is documented in two Agios PRs. That is the confirmable test. Do not file "approved despite missed VOC" — PDUFA is still November 1, 2026.

3. Break checkpoints (not predictions)

Watch these as binary checkpoints. This clip does not assign probabilities or a trade.

CRL (or complete-response equivalent) on the SCD sNDA. No CRL in fetched Agios PRs through Q2 2026. Checkpoint = an Agios 8-K/PR or FDA action letter saying the sNDA is not approved.
Surprise ADCOM. Wiki prior says no ADCOM. Fetched company PRs (July 7 Priority Review; July 30 Q2) do not say FDA communicated that no advisory committee is planned (unlike Agios's 2025 thalassemia sNDA, which did carry that sentence in an older earnings exhibit). Checkpoint = FDA/Agios notice that an AdCom will be held, or a late calendar listing before November 1.
REIGNITE stall. As of fetched records, not stalled:
- July 7 PR: REIGNITE is the required confirmatory trial (NCT07656415).
- Q2 2026 PR, July 30: "Agios dosed the first patient in the REIGNITE Phase 3 trial."
- ClinicalTrials.gov NCT07656415: status RECRUITING; start 2026-07-21; primary completion estimated 2029-08; completion estimated 2030-08; three U.S. sites recruiting (Indianapolis, Grand Rapids, Flowood).
- Checkpoint = hold, termination, enrollment freeze, or protocol rewrite that delays the confirmatory clock.

4. Last-price as-of (Gage mark empty)

Gage mark slot: empty. Filer adds it. This clip only supplies last-price.

Requested "Friday 2026-08-29 close" cannot exist: 2026-08-29 is Saturday. Last regular session before this clip is Friday 2026-08-28.

Field	Value
Ticker	AGIO (NASDAQ)
Close	$33.32
Session	2026-08-28, 4:00 PM EDT — market closed
Change	−0.96 (−2.80%) vs previous close $34.28
Volume	519,739
Day range	33.27 – 34.36
Source	stockanalysis.com/stocks/agio/ and history table stockanalysis.com/stocks/agio/history/ (row Date Aug 28, 2026, Close 33.32)
As-of	2026-08-28 close (fetched 2026-08-31)

Pre-market on the same pages (Aug 31, 2026, 7:13 AM EDT) printed 33.11; do not use pre-market as the as-of close.

5. Wiki miss (dated event)

vault/projects/stock-market/wiki/entities/agios.md (read via gh api, not cloned): created/updated 2026-07-15. One-line summary cites Priority Review despite a missed co-primary; sources point at a July 10, 2026 podcast, not the July 7 company PR. No PDUFA date, no REIGNITE, no last-price, no Gage mark. The July 7 PR's November 1, 2026 goal date was therefore a dated event sitting in public for eight days before the entity update, and still unfiled.

Contradictions and open questions

"No ADCOM" is unverified in the primaries fetched for this clip. Wiki and the July 10 podcast prior assert it. The July 7 PR and July 30 Q2 PR do not. Do not promote "no ADCOM" as a company-confirmed fact until an Agios 8-K/PR or FDA calendar says so.
PYRUKYND vs mitapivat labeling on the SCD sNDA. Task listed "mitapivat / Pyrukynd sNDA." Company PR says mitapivat sNDA. PYRUKYND U.S. indication in that PR is still PK deficiency; AQVESME is thalassemia.
Confirm test is acceptance, not approval. Filing + Priority Review after a missed SCPC co-primary is sourced. Approval-despite-VOC is still the November 1 question.
REIGNITE "underway" vs enrollment scale. Accelerated pathway requires the confirmatory trial underway at decision. First patient was dosed by July 30; CT.gov still shows only three U.S. sites. Whether FDA treats that as "underway" is a review fact, not something this clip can certify.
Native X: user-X search_news and get_users_by_username returned HTTP 403 client-not-enrolled. Honest none-found. search_posts_all was not called.
Grokipedia / encyclopedia: not used.

Provenance

Method: Grok Bot / parallel-deep-research / native X Generated: 2026-08-31

Web sources:

U.S. FDA Grants Priority Review to Agios' sNDA for Mitapivat in Sickle Cell Disease (Jul 07, 2026) — required primary. PDUFA November 1, 2026; Priority Review; accelerated pathway; REIGNITE confirmatory; no ADCOM sentence; no VOC-miss sentence. WebFetch timed out; curl HTTP 200.
Agios Announces Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell Disease (Nov 19, 2025) — missed SCPC/VOC co-primary (2.62 vs 3.05, p=0.1213); hemoglobin co-primary met. Curl HTTP 200.
Agios Reports Second Quarter 2026 Financial Results and Provides Business Update (Jul 30, 2026) — restates PDUFA November 1, 2026; first patient dosed in REIGNITE; no ADCOM sentence. Curl HTTP 200.
ClinicalTrials.gov NCT07656415 REIGNITE — recruiting; start 2026-07-21; primary completion est. 2029-08; three U.S. sites.
stockanalysis.com AGIO quote — $33.32 at close Aug 28, 2026, 4:00 PM EDT.
stockanalysis.com AGIO history — daily row Aug 28, 2026 Close 33.32, volume 519,739.

X sources:

none found — user-X returned 403 client-not-enrolled / "Client Forbidden" on search_news and get_users_by_username. search_posts_all skipped per instructions.

Grokipedia:

not used