pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › PDUFA Calendar › AGIO

Agios Pharmaceuticals (AGIO) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Agios Pharmaceuticals · 1 upcoming · 2 past FDA decisions

Upcoming FDA catalysts

AGIO · Nov 1, 2026Mitapivat (PYRUKYND) - (RISE UP): Sickle cell disease (sNDA)

FDA decision history (2)

Dec 23, 2025✓ ApprovedFDA decisionNov 3, 2025✓ ApprovedFDA decision

Clinical readouts (2)

2027-03Mitapivat2026-06Mitapivat
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates AGIO's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.

AGIO run-up, measured

Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.

Run-up so far, this catalyst
Since its T-120 baseline on 2026-05-12 ($28.42), AGIO is +17.2% to $33.32 at the close on 2026-08-28. The highest close since that baseline is +54.9% above it.
76 of 120 sessions elapsed, 44 to go. Cohort context: across 1,839 past decisions the median peak from T-120 was 17.7% and the median move to the day before the decision was 2.0%.
AGIO's past FDA decisions (n=4)
DecisionOutcomeT-120 to eveT-120 to peak
2025-12-23APPROVAL-29.4%+28.7%
2025-11-03APPROVAL+48.4%+49.1%
2024-08-07APPROVAL+69.4%+97.7%
2022-02-17APPROVAL-29.3%+13.3%
Median across these 4 decisions: +9.5% from T-120 to the eve, +38.9% to the peak. A median over 4 events describes this stock's past only. It is not a forecast, and the cohort figures on the run-up study are the larger statistical base.

Common questions

When is the next FDA decision or readout for Agios Pharmaceuticals (AGIO)?

November 1, 2026. The next catalyst for Agios Pharmaceuticals is Mitapivat (PYRUKYND) - (RISE UP) (PDUFA). That date is a confirmed date. One further catalyst is scheduled after it. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has Agios Pharmaceuticals (AGIO) had an FDA decision before?

Yes, 2 in our archive: 2 approval(s) and 0 Complete Response Letter(s). The most recent was on December 23, 2025 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has AGIO stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 4 decisions: +9.5% from T-120 to the eve, +38.9% to the peak. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this AGIO data come from?

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.