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Incyte Corp (INCY) FDA catalysts & readout calendar

Page updated ·next FDA decision on the calendar ·Data as of Oct 16, 2026 12:20 PM ET
Incyte Corp · no upcoming catalyst on file · 8 past FDA decisions

FDA decision history (8)

Sep 25, 2026✓ ApprovedFDA decisionMay 1, 2026✓ ApprovedFDA decisionApr 8, 2026✕ CRLFDA decisionSep 19, 2025✓ ApprovedFDA decisionJun 18, 2025✓ ApprovedFDA decisionJun 15, 2025unverifiedFDA decisionMay 15, 2025✓ ApprovedFDA decisionJan 16, 2025unverifiedFDA decision

Clinical readouts (3)

2028-06Ruxolitinib2027-09Corticosteroids2026-10Povorcitinib
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This page aggregates INCY'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.

INCY 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.

INCY's past FDA decisions (n=23)
DecisionOutcomeT-120 to eveT-120 to peak
2026-09-25APPROVAL+29.7%+35.4%
2026-05-01APPROVAL-9.9%+4.6%
2026-04-08CRL+10.6%+30.5%
2025-09-19APPROVAL+41.7%+43.3%
2025-06-18APPROVAL-0.0%+9.3%
2025-06-15CRL+0.3%+11.4%
2025-05-15APPROVAL-20.5%+0.0%
2025-01-16APPROVAL+8.3%+24.6%
2024-08-14APPROVAL+2.8%+13.7%
2023-03-23CRL+6.8%+27.1%
2023-03-22APPROVAL+10.6%+29.5%
2022-08-26APPROVAL+3.8%+18.7%
Showing the 12 most recent of 23.
Median across these 23 decisions: +3.8% from T-120 to the eve, +14.1% to the peak. A median over 23 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 Incyte Corp (INCY)?

September 2027. The next catalyst for Incyte Corp is Corticosteroids (readout). That date is known to the month only. 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 Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.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 Incyte Corp (INCY) had an FDA decision before?

Yes, 8 in our archive: 6 approval(s) and 2 Complete Response Letter(s). The most recent was on September 25, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has INCY stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 23 decisions: +3.8% from T-120 to the eve, +14.1% 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 INCY 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.