What is a PDUFA date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target action date for making a regulatory decision on a drug application (NDA or BLA). These dates are critical binary events for biotech investors as they can cause significant stock price movements of 20-70% in either direction.

How does ODIN predict FDA approvals?

ODIN v14 is a 51-feature L2 Ridge regression trained on 2,210 historical FDA PDUFA events (705 CRLs, 32.0% base rate) from 2015-2026. It analyzes signals across regulatory designations, manufacturing risk, therapeutic area history, sponsor experience, clinical trial design, and FDA era effects to produce a calibrated approval probability. It achieves 0.9363 AUC on walk-forward testing with consistent yearly performance (0.89-0.94).

What is the PDUFA runup strategy?

The PDUFA runup strategy is a validated trading approach based on analysis of 934 PDUFA events showing that biotech stocks systematically appreciate in the 25 trading days before an FDA decision date. The strategy enters at T-25 and exits at T-5 or T-7 depending on ODIN tier, capturing the anticipatory move without holding through the binary event.

ODIN assigns each FDA catalyst to one of four conviction tiers: TIER_1 (85%+ approval probability, full position), TIER_2 (65-85%, half position), TIER_3 (40-65%, small speculative or avoid), and TIER_4 (below 40%, no trade). The tiers drive position sizing and risk management for the PDUFA runup trading strategy.

What is a Complete Response Letter (CRL)?

A Complete Response Letter (CRL) is an FDA notification that the agency cannot approve a drug application in its current form. CRLs cite deficiencies in manufacturing (CMC), clinical efficacy, or safety data. Historically, 32.3% of PDUFA decisions result in CRLs. ODIN's strongest signal is prior CRL history, which carries a -3.21 logit penalty.

When was ETON Pharmaceuticals topical baclofen PDUFA date?

ETON Pharmaceuticals topical baclofen had a PDUFA target action date of February 25, 2026. The FDA approved the drug on schedule on February 25, 2026. ODIN scored it at 85.5% TIER_1, and the stock rose +14.7% during the runup from T-25 to T-7. Track live PDUFA status and ODIN AI approval probability (AUC 0.9363) at pdufa.bio/eton-pdufa.

What is the Vanda Pharmaceuticals PDUFA date in February 2026?

Vanda Pharmaceuticals (VNDA) had a PDUFA target action date of February 21, 2026 for Bysanti (milsaperidone) for schizophrenia. The FDA approved the drug one day early on February 20, 2026. ODIN scored it at 89.7% TIER_1, and the stock rose +44% after hours. Track live PDUFA status and ODIN AI approval probability (AUC 0.9363) at pdufa.bio/calendar.

What are the upcoming PDUFA dates for February 2026?

Key February 2026 PDUFA dates include ETON Topical Baclofen (Feb 25, APPROVED), VNDA Bysanti (Feb 21, APPROVED), OTSKF INQOVI+Venetoclax for AML (Feb 25), REGN Dupixent for allergic fungal rhinosinusitis (Feb 28, APPROVED), and ASND Navepegritide for anemia of CKD (Feb 28). The full Q1 2026 calendar with ODIN AI biotech catalyst scores is available at pdufa.bio/pdufa-calendar-2026.

What FDA approvals are expected in Q1 2026?

Q1 2026 features approximately 10-12 FDA PDUFA decisions, including high-profile oncology, immunology, and endocrinology catalysts. Key names include BMY deucravacitinib for UC (March 6), LLY orforglipron for diabetes (April 10), RCKT Kresladi gene therapy (March 28), and LNTH Ga68-edotreotide for NET imaging (March 29). Track all dates with ODIN probability scores at pdufa.bio.

Biotech Catalyst Heatmap

Interactive visual tool for scanning 200+ upcoming PDUFA dates, phase readouts, and earnings

Real-time updates • Color-coded by ODIN tier • Portfolio risk clustering

What is the Catalyst Heatmap?

The PDUFA.BIO Catalyst Heatmap is an interactive calendar view showing 200+ upcoming biotech catalyst events over the next 12 months. Instead of scrolling through a text calendar, the heatmap displays each event as a colored square, allowing you to instantly visualize:

Which events are coming up
Which ones have highest/lowest approval probability (via ODIN tier color)
How clustered catalysts are on specific dates (portfolio risk compression)
Which sectors (oncology, rare disease, etc.) dominate each quarter

This visual approach is faster than searching a spreadsheet and helps traders identify portfolio concentration risk and sector rotation opportunities.

Color Coding & ODIN Tiers

GREEN (TIER_1/2)

High confidence approvals. 80-93%+ accuracy. Low volatility runup potential. Best candidates for catalyst trading.

YELLOW (TIER_3)

Mixed signals. 60% accuracy. Moderate volatility. Use for sector rotation, avoid as primary positions.

RED (TIER_4)

High risk rejections. <50% accuracy. Avoid for runup trading. Use for short thesis research only.

Key Use Cases

Portfolio Scanning

Quickly scan your holdings for upcoming catalysts in the next 30-60 days. Identify which positions will have binary events and adjust exposure accordingly. The heatmap shows you at a glance if Q2 is catalyst-heavy vs quiet.

Sector Rotation

Look for quarter-to-quarter shifts in catalyst clusters. Example: Q1 is heavy oncology, Q3 is rare disease. Rotate your biotech exposure accordingly. The heatmap reveals these macro trends in seconds.

Risk Clustering

Identify dates where 3-5+ catalysts cluster (e.g., 3 PDUFA decisions on July 21). This signals high IV volatility, wider bid-ask spreads, and potential gap risk. Avoid overconcentration on those dates.

How to Read the Heatmap

X-Axis (Weeks)

Horizontal rows represent weeks (Monday-Sunday). Scroll right to see 3-6 months ahead.

Y-Axis (Companies/Tickers)

Each row represents a company with upcoming catalysts. Tickers are sorted by market cap (large to small, top to bottom).

Cell Color & Density

Each colored square = one catalyst event. The deeper the color, the higher the ODIN confidence. Darker greens are TIER_1 (93%+ accuracy). Lighter greens are TIER_2 (80%). Same logic for yellow and red.

Hovering Over a Cell

Hover over any colored square to see: ticker, company name, catalyst type (PDUFA/Readout/Earnings), expected date, ODIN tier, and approval probability.

Frequently Asked Questions

Why is a catalyst gray (no color)?

Gray means ODIN hasn't yet assigned a tier (rare for major PDUFAs, more common for smaller companies or recent regulatory filings). As the event gets closer (T-30 days), ODIN generates a tier prediction and the cell turns green/yellow/red.

Can I filter by sector or ODIN tier?

Yes. Use the filter dropdowns above the heatmap to show only: oncology, rare disease, immunology, etc. You can also filter by TIER_1 only (to see highest confidence trades), or hide TIER_4 (to reduce noise). Filters work in real-time.

How often is the heatmap updated?

The heatmap updates in real-time as new PDUFA dates are announced by the FDA. ODIN tier predictions update daily as new price and options data arrives. If you see a date change or new ticker appear, the data was just published to our database.