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.

Can I screen by market cap and therapeutic area?

Yes. The Screener includes filters for Market Cap Range (mega-cap to micro-cap), Therapeutic Area (oncology, immunology, rare disease, etc.), and Stock Price. Combine filters to identify nano-cap breakout candidates or mega-cap catalysts.

What does "Runup Strategy" mean?

A runup is when biotech stock gains 5–30% in the weeks before a catalyst (usually a PDUFA approval). TIER_1 and TIER_2 ODIN events are prime runup candidates. Screen for these tiers + your desired date range to find early-entry opportunities.

Biotech Catalyst Screener

Advanced filtering engine for biotech catalysts. Search across 200+ pending PDUFA dates, clinical readouts, and earnings events. Filter by ODIN tier, event type, therapeutic area, market cap, and date range to find your next winner.

Build custom screens in seconds. Find TIER_1 nano-cap PDUFA approvals. Screen for oncology breakout candidates. Identify earnings + PDUFA combos. Export data for backtesting and portfolio tracking.

Screening Filters

ODIN Tier

TIER_1 (85%+), TIER_2 (65–85%), TIER_3 (40–65%), TIER_4 (<40%)

Filter by approval confidence level

Event Type

PDUFA Decision, Phase Readout, Earnings, AdCom, FDA Meeting

Focus on specific catalyst types

Therapeutic Area

Oncology, Immunology, Rare Disease, CNS, Cardiovascular, Infectious Disease, Dermatology

Screen by disease focus

Market Cap

Mega-cap (>$10B), Large ($2–10B), Mid ($500M–2B), Small ($50M–500M), Micro (<$50M)

Target volatility/runup potential

Date Range

Custom start & end dates

Narrow to specific weeks/months

Stock Price

Min & max price per share

Exclude penny stocks or expensive names

Common Screening Strategies

TIER_1 Nano-Cap Runup

Screen for TIER_1 PDUFA approvals with market cap <$50M, coming in next 30 days. These micro-caps often move 20%+ on approval. Early entry = higher upside.

✓ ODIN Tier: TIER_1, ✓ Event Type: PDUFA Decision, ✓ Market Cap: &lt;$50M, ✓ Date Range: Next 30 days

Oncology Breakout Candidates

Find all TIER_1 + TIER_2 cancer drug PDUFAs in Q1–Q2 2026. Oncology has highest baseline approval rates (~70%). Screen by therapeutic area = focused thesis.

✓ Therapeutic Area: Oncology, ✓ ODIN Tier: TIER_1, TIER_2, ✓ Event Type: PDUFA, ✓ Date Range: Q1–Q2

Earnings + PDUFA Combo

Screen for companies with BOTH earnings and PDUFA decisions in same week. Dual catalysts amplify stock moves. Can trade the catalyst pair for bigger swings.

✓ Event Type: Multiple (PDUFA + Earnings), ✓ Date Range: Same week

Phase Readout Opportunities

Find Phase 2 and Phase 3 readouts coming in next 60 days. Earlier-stage readouts are less predictable but offer higher upside. Good for speculative positioning.

✓ Event Type: Phase Readout, ✓ Date Range: Next 60 days

How to Use the Screener

Set ODIN Tier: Decide your confidence threshold. TIER_1 = high conviction; TIER_3 = speculative. Most conservative traders focus on TIER_1 + TIER_2.
Choose Event Type: Are you looking for PDUFA approvals, clinical readouts, earnings, or advisory committee votes? Select what moves the stock.
Filter by Therapeutic Area: Oncology and immunology have higher baseline approval rates. Rare disease = smaller market but niche expertise advantage.
Set Market Cap Range: Large-cap = lower volatility; micro-cap = higher runup potential. Choose based on your risk tolerance and portfolio size.
Narrow by Date Range: Looking for next 2 weeks? Next 3 months? Set your timeframe and see pending catalysts.
Export & Backtest: Download filtered results as CSV. Backtest your screen against historical ODIN scores and stock performance to validate your thesis.

Frequently Asked Questions

How do I find TIER_1 PDUFA events?

Use the Screener and set Tier to TIER_1, Event Type to PDUFA Decision. Sort by date to see which approvals are coming soonest. Each result shows the ODIN score, ticker, drug name, and PDUFA date.

Can I combine multiple filters?

Yes! Filters stack. For example: Tier=TIER_1, Therapeutic Area=Oncology, Market Cap=<$500M, Date Range=March. Results show the intersection—TIER_1 cancer drug approvals coming in March from small companies.

What's the difference between PDUFA Decision and Phase Readout?

PDUFA Decision is an FDA approval/rejection decision. Phase Readout is clinical trial data release (Phase 2 results, Phase 3 topline, etc.). PDUFA dates are more predictable catalysts; phase readouts can swing either way.

Screener Data & Metrics

Total Events Indexed

200+

TIER_1 Events (High Conviction)

40–50

Average ODIN Score

65%

Update Frequency

Daily

Therapeutic Areas Covered

10+

Data Sources

SEC Filings, FDA, Clinical Trials