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How Biotech Stocks Move Around FDA Decisions
Original data from 63 PDUFA decisions BioRadar tracked between May 2025 and Jul 2026. Updated automatically as new FDA decisions are archived.
Across 61 FDA decision dates with price data, biotech stocks moved an average of -2.0% on the decision day and -4.4% over the following five trading days. Stocks rose an average of +4.2% in the 30 days before the decision, then 52% closed lower on the day itself — the classic "run-up then fade" pattern. The average absolute move was 9.3%, and single events ranged from +41.5% to -70.7%.
Distribution of decision-day moves
Most FDA decision days are quieter than headlines suggest — but the tails are brutal. Of 61 events:
57% of decisions landed within ±5%, yet roughly 1 in 9 events moved more than 20% in one direction. FDA decisions are high-variance, not one-directional.
The run-up then fade pattern
On average, biotech stocks in this dataset climbed +4.2% in the 30 days before their PDUFA date (60% rose during the run-up window), then gave back ground: -2.0% on the decision day and -4.4% five days later. In other words, the anticipation was often rewarded more reliably than the event itself.
Learn the terms behind these numbers: PDUFA date, Complete Response Letter, full glossary.
By application type
| Application type | Events | Avg 30d run-up | Avg decision-day move | % closed up |
|---|---|---|---|---|
| NDA | 38 | +2.5% | -1.1% | 50% |
| BLA | 15 | +10.8% | -5.1% | 40% |
| sNDA | 8 | -2.6% | -0.6% | 50% |
NDA = New Drug Application (small molecules) • BLA = Biologics License Application • sNDA = supplemental NDA (label expansions).
What this means for traders
- The pre-decision run-up was, on average, more reliable than the decision-day move. Many traders take risk off before the binary event for this reason.
- Most decision days are quiet, but position sizing matters because the tails (±20%+) are severe and hard to predict.
- Averages hide the binary nature of each event — a single approval or CRL can gap a stock 40%+ either way.
Know which FDA decisions are coming — and their approval odds
BioRadar tracks every upcoming PDUFA date with a Probability of Approval score, cash-runway and dilution risk, and free email alerts. Position before the run-up, not after.
See the PDUFA Calendar →Methodology
These statistics are computed from 63 historical PDUFA (FDA decision) events tracked by BioRadar between May 2025 and July 2026. Price reactions use Yahoo Finance daily closes: the 30-day run-up compares the close ~30 calendar days before the event to the close the day before; the decision-day move compares the first close on or after the event to the prior close; the 5-day move extends that to five trading days later. Events are drawn from SEC and FDA filings. Figures update automatically as new decisions are archived. This is informational only, not investment advice.
Last updated: July 17, 2026 • Browse the full historical outcomes table →