Research · Biotech · Quantitative Finance

FDA Approval Probability Engine

Free, calibrated FDA approval probabilities for every public biotech.

0.843
AUC-ROC
2,026
Events Validated
35
Factors
83%
Accuracy
Nearest PDUFA Decisions
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Benchmarks

AUC-ROC as reported on each work's own temporal holdout.

ApprovalAlpha (this work)2026 · 2,043 events
0.843
0.50 (random)0.90
Lo et al. (Harvard)2019 · 1,870 events
0.810
0.50 (random)0.90
ChemAP (Cho et al.)2024 · 3,041 events
0.782
0.50 (random)0.90
Phase × Indication Base Ratenaive baseline
0.620
0.50 (random)0.90

Published benchmarks use different datasets and time periods; direct comparison is approximate. See methodology for validation details and references.