This page aggregates AMRX'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.
AMRX 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.
AMRX's past FDA decisions (n=27)
Decision
Outcome
T-120 to eve
T-120 to peak
2026-06-04
APPROVAL
+7.6%
+26.9%
2025-12-22
APPROVAL
+53.1%
+54.0%
2025-12-22
APPROVAL
+53.1%
+54.0%
2025-12-01
APPROVAL
+64.5%
+64.5%
2025-11-13
APPROVAL
+65.5%
+66.2%
2025-10-29
APPROVAL
+42.5%
+46.1%
2025-09-23
APPROVAL
+19.3%
+20.4%
2025-09-11
APPROVAL
+12.5%
+13.3%
2025-09-04
APPROVAL
+7.4%
+8.0%
2025-06-12
APPROVAL
+0.4%
+16.3%
2025-05-15
APPROVAL
-11.8%
+8.2%
2025-01-23
APPROVAL
+18.0%
+28.1%
Showing the 12 most recent of 27.
Median across these 27 decisions: +22.9% from T-120 to the eve, +35.7% to the peak. A median over 27 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 for Amneal Pharmaceuticals, Inc. (AMRX)?
Amneal Pharmaceuticals, Inc. has no dated FDA catalyst on our calendar right now. That means no scheduled decision or readout date has been published in a source we can point to, not that none exists. We would rather say that than estimate one.
Has Amneal Pharmaceuticals, Inc. (AMRX) had an FDA decision before?
Yes, 11 in our archive: 11 approval(s) and 0 Complete Response Letter(s). The most recent was on June 4, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.
How has AMRX stock moved into its FDA decisions?
Measured from this company's own daily closing prices: Median across these 27 decisions: +22.9% from T-120 to the eve, +35.7% 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 AMRX 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.