FDA PDUFA Calendar 2026
Track all FDA PDUFA approval dates, clinical readouts, and earnings across biotech companies. Filter by ticker, event type, therapeutic area, and date range. Each event includes an ODIN AI approval probability score powered by machine learning models trained on historical FDA outcomes.
The PDUFA (Prescription Drug User Fee Act) calendar is your central hub for event-driven biotech investing. Discover catalysts weeks or months in advance, screen for runup candidates, and validate predictions against ODIN scores.
Upcoming PDUFA Events (February–March 2026)
| Ticker | Drug / Event | PDUFA Date | ODIN Score | Tier |
|---|---|---|---|---|
| OTSKF | Olanzapine ER | Feb 25, 2026 | 87.2% | TIER_1 |
| REGN | Eyerestasis Phase 2 Readout | Feb 28, 2026 | 72.4% | TIER_2 |
| ASND | Asundexian (Factor XIa) | Feb 28, 2026 | 81.6% | TIER_1 |
| BMY | Opdualag Combination (Lung) | Mar 6, 2026 | 65.3% | TIER_2 |
| LLY | Tirzepatide Phase 3 (OB) | Mar 25, 2026 | 92.1% | TIER_1 |
| LNTH | Gene Therapy NDA | Mar 29, 2026 | 43.8% | TIER_3 |
Sample data shown. Full calendar contains 200+ events. ODIN scores updated daily based on latest clinical trial data, regulatory designations, and sponsor track record.
How to Use the Calendar
- Search by ticker: Type a stock symbol to find all upcoming catalysts for that company. See PDUFA dates, readouts, earnings, and more.
- Filter by event type: Select PDUFA decisions, Phase readouts, Earnings, or FDA meetings. Combine filters to narrow results.
- Check ODIN scores: Each event shows an ODIN approval probability (0–100%). TIER_1 events have >85% predicted success; TIER_4 <40%.
- Set alerts: Subscribe to notifications for specific tickers or therapeutic areas. Get pinged 7, 3, and 1 day before each catalyst.
- Export data: Download filtered events as CSV for backtesting, portfolio tracking, or integration with trading platforms.
Frequently Asked Questions
What is a PDUFA date?
The FDA's target decision date for reviewing a drug application (NDA or BLA). PDUFA stands for Prescription Drug User Fee Act. The FDA commits to reviewing applications within standard (10 months) or priority (6 months) timelines. PDUFA dates are major stock catalysts.
How often is the calendar updated?
The calendar syncs with FDA databases daily. New PDUFA dates are added when companies file applications. ODIN scores are recomputed nightly to reflect the latest clinical data, regulatory designations, and sponsor performance metrics.
Can I filter by therapeutic area?
Yes. Use the therapeutic area filter to see only oncology, immunology, rare disease, cardiovascular, or other specialty categories. Combine with market cap and date range filters to build custom screens.
February 2026 PDUFA Heatmap
PDUFA February 2026 Heatmap
Therapeutic area × Day heatmap. Rows = sectors, Columns = Feb dates. Color = event status.