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.

What is a PDUFA date and why does it matter?

A PDUFA date is the FDA's target decision date for reviewing a drug application (NDA or BLA). It's a key catalyst for biotech stocks because FDA approval or rejection can significantly impact the company's valuation and stock price.

How do I filter events in the PDUFA Calendar?

Use the calendar's filter panel to search by ticker symbol, event type (PDUFA, Phase Readout, Earnings), therapeutic area, and date range. Results show ODIN scores, market cap, and all relevant catalyst details.

Can I export calendar data?

Yes. Filter your results and export as CSV for use in spreadsheets or trading platforms. Include ODIN scores, approval probabilities, and historical win rates for backtesting.

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

✅ Latest ODIN Win: ASND Navepegritide (YUVIWEL) Approved for Achondroplasia
ODIN Score: TIER_1 (88.9%) | Outcome: Accelerated Approval ✓ (1 day early) | Move: +6%
View Cryptographic Proof →
PDUFA February 2026 HeatmapTherapeutic area × Day heatmap. Rows = sectors, Columns = Feb dates. Color = event status.
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CNS
VNDAVNDA • CNS • APPROVED
Oncology
OTSKFOTSKF • Oncology • pending
Immunology
REGNREGN • Immunology • APPROVED
Rare Disease
RGNXRGNX • Rare Disease • CRL
ASNDASND • Rare Disease • APPROVED
Hematology
IRONIRON • Hematology • CRL
Ophthalmology
CHRSCHRS • Ophthalmology • pending
Metabolic/Endocrine
ASNDASND • Metabolic/Endocrine • APPROVED
ETONETON • Metabolic/Endocrine • APPROVED
BMRNBMRN • Metabolic/Endocrine • pending
Approved
CRL (Complete Response Letter)
Pending Decision
No Event