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PDUFA.BIO

ODIN v1108

Engine: v1108Trained: 4,200+ eventsScenarios: 40B+

Tue Mar 3, 2026

12 this week

Biotech Market Intelligence

Historical FDA approval rates by therapeutic area, ODIN engine statistics, and biotech catalyst risk analysis for quantitative traders.

HISTORICAL FDA APPROVAL RATES BY THERAPEUTIC AREA

Based on 4,200+ event backtest (2015-2026 PDUFA decisions & phase readouts)

Vaccines

92.3% (12/13)

3 active

Infectious Disease

91.1% (41/45)

Dermatology

90.0% (18/20)

4 active

Respiratory

88.2% (15/17)

2 active

Immunology

88.0% (22/25)

10 active

Oncology

87.2% (68/78)

18 active

Women's Health

83.3% (5/6)

Hematology

82.4% (28/34)

1 active

Rare Disease

81.8% (45/55)

11 active

Cardiovascular

79.2% (19/24)

4 active

Metabolic

77.4% (24/31)

2 active

GI/Hepatology

75.0% (12/16)

3 active

CNS

73.1% (38/52)

9 active

Musculoskeletal

72.7% (8/11)

Ophthalmology

69.2% (9/13)

2 active

Nephrology

66.7% (6/9)

3 active

Pain Management

42.9% (3/7)

ODIN TA RISK CLASSIFICATION

LOW RISK

Oncology87%

Immunology88%

Dermatology90%

Vaccines92%

Infectious Disease91%

Historically high approval rates, well-established regulatory pathways

MODERATE RISK

CNS73%

Cardiovascular79%

Metabolic77%

Rare Disease82%

Respiratory88%

Mixed track record, often complex endpoints or safety profiles

HIGH RISK

Ophthalmology69%

GI/Hepatology75%

Nephrology67%

Hematology82%

Musculoskeletal73%

Below-average approval rates, challenging regulatory landscape

ODIN v1108 ENGINE STATS

PDUFAs Trained

2,200+

Phase Readouts

2,000+

Scenarios Simulated

40B+

Architecture

GPU Logistic

ODIN BACKTEST PERFORMANCE

4,200+ historical events (2015-2026)

ACCURACY BY TIER

Tier 1 (>85%)

98%

197/201

Tier 2 (70-85%)

89.3%

108/121

Tier 3 (60-70%)

77.4%

72/93

Tier 4 (<60%)

87.3%

62/71

ACCURACY BY THERAPEUTIC AREA

82.1%

Oncology

112 events

73.5%

CNS

68 events

88.9%

Immunology

54 events

91.7%

Rare Disease

48 events

83.3%

Cardiovascular

36 events

84.4%

Infectious Disease

32 events

85.7%

Endocrinology

28 events

87.5%

Dermatology

24 events

88.9%

Ophthalmology

18 events

81.8%

Other

66 events

GLOSSARY — FDA & BIOTECH TERMS

PDUFA

Prescription Drug User Fee Act — the FDA's deadline date to complete review of a drug application. The FDA must respond by this date.

NDA

New Drug Application — formal submission to FDA requesting approval to market a new drug.

sNDA

Supplemental NDA — application to modify an already-approved NDA (new indication, dosage form, etc.).

BLA

Biologics License Application — like an NDA but for biological products (antibodies, vaccines, gene therapies).

sBLA

Supplemental BLA — modification to an already-approved biologic.

CRL

Complete Response Letter — FDA's formal rejection, citing deficiencies that must be resolved before approval.

Priority Review

FDA designates drugs treating serious conditions with potential to provide significant improvement. Review target: 6 months vs standard 10.

Breakthrough Therapy

Expedited development program for drugs showing substantial improvement over existing treatments based on preliminary clinical evidence.

Orphan Drug

Designation for drugs treating rare diseases (fewer than 200,000 patients in the US). Provides tax credits and 7 years market exclusivity.

Fast Track

FDA process to facilitate development of drugs treating serious conditions. Enables more frequent FDA interactions and rolling review.

Accelerated Approval

Approval based on a surrogate endpoint (like tumor shrinkage) rather than clinical outcome. Requires confirmatory trials.

Phase 2

Mid-stage clinical trial testing effectiveness in 100-300 patients. First time a drug's therapeutic effect is measured.

Phase 3

Large-scale clinical trial (300-3,000+ patients) confirming effectiveness and monitoring side effects. Required for FDA submission.

Phase 3 Readout

Announcement of Phase 3 trial results — typically a binary catalyst for the stock price.

TIER_1

Highest conviction tier (≥85% probability). ODIN identifies strong approval signals. Action: LONG, 100% sizing, exit T-5.

TIER_2

Moderate conviction tier (65-85% probability). Solid fundamentals with some risk factors. Action: CAUTIOUS LONG, 50% sizing, exit T-5.

TIER_3

Low conviction tier (40-65% probability). Mixed signals — the runup may still work but binary risk is elevated. Action: AVOID or small speculative, 25% sizing, exit T-7.

TIER_4

No-trade tier (<40% probability). Significant risk factors. Action: NO TRADE — no exceptions regardless of revenue impact.

Therapeutic Area

The medical field a drug targets (e.g., Oncology, CNS, Immunology). Each TA has different historical FDA approval rates.

Cash Runway

Estimated months of cash remaining based on current burn rate. Companies with <12 months may need to raise capital.

ODIN Score

Approval probability from ODIN v1108, a 54-weight logistic regression trained on 2,210 PDUFA events (713 CRLs). Three weight layers: v1066 canonical (33 weights), v1070 extensions (15 era/gene therapy weights), v1108 interactions (6 compound features). Validation AUC 0.88, walk-forward AUC 0.91.

PDUFA.BIO

FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015–2026).

PLATFORM

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What Is a PDUFA Date?Glossary Research About ODIN Data Sources Partners Advertise API Disclaimer

PDUFA.BIO is the data-driven FDA PDUFA calendar and biotech catalyst calendar built for quantitative investors. Track upcoming PDUFA dates for 2026, FDA drug approval action dates, and biotech earnings dates in a unified, filterable calendar. Learn what a PDUFA date is and how the ODIN AI scoring engine generates FDA approval probability scores. Use the biotech catalyst screener to filter by ticker, therapeutic area, and ODIN tier. Explore the PDUFA runup strategy and verify ODIN's accuracy on the verified track record page. Browse our biotech glossary and catalyst research hub.

DISCLAIMER: PDUFA.BIO is not affiliated with, endorsed by, or connected to the U.S. Food & Drug Administration (FDA) or any government agency. The name "PDUFA" refers to the Prescription Drug User Fee Act and is used descriptively. This site does not provide financial, investment, legal, or medical advice. PDUFA.BIO is not a registered investment advisor, broker-dealer, or financial planner. Probability scores are generated by machine-learning models based on historical data and publicly available information. These scores are statistical estimates, not predictions or guarantees of FDA action or securities performance. Past approval rates do not guarantee future results.

RISK WARNING: Investing in biotechnology and pharmaceutical securities involves substantial risk, including the risk of total loss of capital. Binary catalyst events (such as PDUFA dates) can result in extreme price volatility. You should not invest money you cannot afford to lose. Always consult with a qualified financial advisor before making investment decisions. PDUFA.BIO, its operators, contributors, and affiliates accept no responsibility or liability for any losses arising from use of this site.