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Home › PDUFA Calendar › TAK

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) (TAK) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Takeda Pharmaceutical Company Limited · no upcoming catalyst on file · 3 past FDA decisions

FDA decision history (3)

Aug 5, 2026✓ ApprovedFDA decisionSep 5, 2025unverifiedFDA decisionJun 30, 2025✓ ApprovedFDA decision

Clinical readouts (1)

2027-12Tislelizumab
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates TAK'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.

TAK 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 2026-04-09 ($18.46), TAK is -2.3% to $18.03 at the close on 2026-08-28. The highest close since that baseline is +0.0% above it.
99 of 120 sessions elapsed, 21 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%.
TAK's past FDA decisions (n=22)
DecisionOutcomeT-120 to eveT-120 to peak
2026-08-05APPROVAL-8.5%+3.9%
2025-09-05APPROVAL+1.7%+3.3%
2025-06-30APPROVAL+14.0%+16.2%
2024-04-18APPROVAL-9.8%+3.2%
2024-03-19APPROVAL-8.8%+0.0%
2024-02-13APPROVAL-4.8%+8.6%
2024-02-12APPROVAL-5.4%+8.4%
2024-01-29APPROVAL-4.0%+7.3%
2024-01-16APPROVAL-2.8%+5.4%
2023-11-09APPROVAL-14.3%+2.2%
2023-11-08APPROVAL-15.4%+0.9%
2023-09-27APPROVAL-4.3%+2.6%
Showing the 12 most recent of 22.
Median across these 22 decisions: -7.6% from T-120 to the eve, +3.6% to the peak. A median over 22 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 Takeda Pharmaceutical Company Limited American Depositary Shares (TAK)?

December 2027. The next catalyst for Takeda Pharmaceutical Company Limited American Depositary Shares is Tislelizumab (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 Takeda Pharmaceutical Company Limited American Depositary Shares (TAK) had an FDA decision before?

Yes, 3 in our archive: 3 approval(s) and 0 Complete Response Letter(s). The most recent was on August 5, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has TAK stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 22 decisions: -7.6% from T-120 to the eve, +3.6% 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 TAK 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.