PDUFA Runup Heatmap
Historical pre-PDUFA price runup returns across every tier, market cap, and disease area. Find the exact window where small-cap biotechs move the most â before decision day.
| Segment | T-60âT-7 | T-30âT-7 | T-25âT-7 | T-18âT-7 | T-7âT-1 |
|---|---|---|---|---|---|
| TIER_1 | +3.9% 57% win · n=614 | +3.0% 57% win · n=614 | +2.0% 55% win · n=614 | +1.6% 55% win · n=614 | -0.2% 45% win · n=614 |
| TIER_2 | +2.6% 54% win · n=299 | +1.0% 57% win · n=299 | +1.3% 55% win · n=299 | +1.9% 56% win · n=299 | +0.2% 48% win · n=299 |
| TIER_3 | +5.9% 55% win · n=306 | +3.9% 53% win · n=307 | +3.4% 54% win · n=307 | +1.7% 52% win · n=307 | +1.0% 51% win · n=307 |
| TIER_4 | +0.6% 43% win · n=498 | +1.2% 48% win · n=499 | +1.4% 48% win · n=499 | +1.8% 48% win · n=499 | +1.5% 49% win · n=499 |
ODIN Pro gives you the exact tier à market cap cell for every upcoming PDUFA event, plus real-time window alerts.
Get ODIN Pro â $29/moHow to Read This Heatmap
Each cell shows the average return for stocks in that segment during the given time window before a PDUFA decision date. Green cells indicate positive average returns; red cells indicate negative. The win rate shows what percentage of events in that segment had a positive return.
T-25 to T-7 means the 18-calendar-day period starting 25 days before the PDUFA date and ending 7 days before. This is the core runup window where anticipation-driven buying is strongest, before the final week's profit-taking and volatility.
ODIN tiers are assigned by the Gungnir v24 model (AUC 0.988). Tier 1 represents the highest-conviction approval predictions; Tier 4 represents low confidence or likely CRL outcomes. Returns are calculated close-to-close using FMP historical price data, excluding events where price data was unavailable.
What Is the PDUFA Runup?
The PDUFA runup is a well-documented trading pattern in biotech stocks. In the weeks leading up to an FDA decision date, stocks experience anticipation-driven price momentum as traders position for the binary event. This effect is strongest in small- and micro-cap names where float is limited and retail participation is high.
Our analysis of 1,719 PDUFA events from 2020-2025 shows the pattern is real, quantifiable, and varies dramatically by company characteristics. The key insight: not all runups are created equal. Tier 1 small caps in the T-60 to T-7 window returned +19.2% on average with a 68% win rate, while Tier 4 large caps were essentially flat.
Frequently Asked Questions
Why does the runup work?
Retail and institutional traders front-run expected volatility, options market makers hedge by buying shares, and limited float in small caps amplifies momentum. The effect is consistent across 6 years of data but is NOT guaranteed on any single trade.
What does T-25 mean?
T-0 is the PDUFA decision date. T-25 means 25 calendar days before that date. The runup window T-25 to T-7 is the 18-day sweet spot before final-week volatility and profit-taking.
Should I hold through the PDUFA decision?
The runup strategy is designed to capture pre-event momentum and exit before the binary outcome. Exit by T-7 (or T-2 at the latest) to avoid the coin-flip risk of the actual FDA decision.
Disclaimer: This heatmap presents historical statistical analysis for educational and research purposes only. Past performance does not guarantee future results. The PDUFA runup pattern is a statistical tendency, not a certainty. Individual trades can and do lose money. This is not financial advice. Always do your own research and consult a financial advisor before making investment decisions. PDUFA.BIO and its operators are not registered investment advisors. See our full disclaimer.