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Pfizer Inc. (PFE) FDA catalysts & readout calendar

Page updated ·next FDA decision on the calendar ·Data as of Oct 16, 2026 12:20 PM ET
Pfizer Inc. · no upcoming catalyst on file · 11 past FDA decisions

FDA decision history (11)

Oct 7, 2026✓ ApprovedFDA decisionAug 27, 2026✓ ApprovedFDA decisionJul 10, 2026✓ ApprovedFDA decisionJun 24, 2026✓ ApprovedFDA decisionJun 8, 2026✓ ApprovedFDA decisionMay 1, 2026✓ ApprovedFDA decisionFeb 24, 2026✓ ApprovedFDA decisionDec 17, 2025unverifiedFDA decisionNov 21, 2025✓ ApprovedFDA decisionAug 27, 2025unverifiedFDA decisionFeb 12, 2025✓ ApprovedFDA decision

Clinical readouts (2)

2026-12Elranatamab2026-10Palbociclib
Full PDUFA calendar →All FDA decisions →Phase readouts →
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This page aggregates PFE'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.

PFE 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.

PFE's past FDA decisions (n=81)
DecisionOutcomeT-120 to eveT-120 to peak
2026-10-07APPROVAL+1.1%+6.7%
2026-08-27APPROVAL+6.4%+7.4%
2026-07-10APPROVAL-5.2%+11.6%
2026-06-24APPROVAL-1.1%+14.2%
2026-06-08APPROVAL+0.9%+10.7%
2026-05-01APPROVAL+8.5%+16.0%
2026-02-24APPROVAL+9.3%+12.0%
2025-12-17CRL+5.3%+12.9%
2025-11-21APPROVAL+4.0%+16.7%
2025-08-27APPROVAL-3.9%+3.0%
2025-02-12APPROVAL-11.4%+4.8%
2024-12-20APPROVAL-8.7%+11.2%
Showing the 12 most recent of 81.
Median across these 81 decisions: -3.6% from T-120 to the eve, +11.5% to the peak. A median over 81 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 Pfizer Inc. (PFE)?

December 2026. The next catalyst for Pfizer Inc. is Elranatamab (readout). That date is known to the month only. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.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 Pfizer Inc. (PFE) had an FDA decision before?

Yes, 11 in our archive: 10 approval(s) and 1 Complete Response Letter(s). The most recent was on October 7, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has PFE stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 81 decisions: -3.6% from T-120 to the eve, +11.5% 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 PFE 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.