PDUFA run-up by year: 2020 to 2026
What biotech stocks actually did into and out of an FDA decision, measured on real daily closes across 1,862 PDUFA events from 2020-01-08 to 2026-10-08. Updated as each decision is published and folded back into the dataset. Medians throughout. A handful of 300% moves would make means meaningless here. All run-up figures use a single T-120 baseline (120 trading days before the decision), the same baseline quoted everywhere else on the site.
By year
| Year | Events | Run-up T-120→T-1 | Peak run-up from T-120 | Run-up 30d | Decision day | T+5 | Approval rate |
|---|---|---|---|---|---|---|---|
| 2020 | 185 | +4.2% | +16.1% | +1.8% | −0.1% | −0.3% | 81.1% |
| 2021 | 255 | +2.3% | +13.4% | +0.3% | +0.0% | −0.5% | 69.4% |
| 2022 | 232 | −0.7% | +15.2% | −0.4% | +0.1% | +0.0% | 64.2% |
| 2023 | 360 | −5.2% | +12.7% | −0.8% | −0.3% | −0.3% | 64.2% |
| 2024 | 341 | +9.4% | +22.7% | +0.6% | −0.1% | −0.1% | 74.8% |
| 2025 | 323 | +0.7% | +20.9% | +2.0% | +0.1% | +0.0% | 70.0% |
| 2026* | 166 | +12.1% | +30.5% | +1.9% | +0.1% | +0.6% | 86.1% |
Decision-day move by market-cap tier
The single most useful number here: how far a stock typically moves on the day, by company size. This is the figure quoted on every individual decision page.
| Market-cap tier | Events | Median absolute move |
|---|---|---|
| Nano (<$50M) | 117 | 8.0% |
| Micro ($50M-$300M) | 308 | 4.6% |
| Small ($300M-$2B) | 280 | 3.6% |
| Mid ($2B-$10B) | 235 | 2.1% |
| Large (>$10B) | 837 | 1.0% |
Method & limits
Universe: every FDA PDUFA decision we have published in our decision archive with usable daily price
history, 2020-01-08 to 2026-10-08. Prices are split-adjusted daily closes (Polygon). Returns are computed in trading days,
not calendar days. Outcomes are taken from our published decision archive, each of which is sourced to a primary FDA,
SEC or company filing.
T-120 coverage. 1,791 of 1,862 events (96.2%) have a full 120 sessions of prior trading history; the rest are companies that had not been listed long enough, and they are excluded from the T-120 columns rather than measured over a short window. Coverage is 100% for 2026.
Limits worth stating. Daily closes understate intraday ranges, so every move here is a floor, not a ceiling.
Medians hide dispersion, a typical move of a few percent coexists with a long tail of very large ones. A
partial current year is marked with an asterisk and will move as more decisions land. Market-cap tier is assigned
from the company's size at the time we recorded the event. This is a description of what happened historically; it
is not a prediction and not investment advice.
Reuse encouraged with attribution: “pdufa.bio, PDUFA run-up study (n=1,862, 2020-01-08 to 2026-10-08)”. See all research and the free API.
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Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. past behaviour does not predict future outcomes. Last computed 2026-10-11. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.
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