Can AI Predict FDA Decisions?

Three AI models. Real FDA drug approvals. Predictions locked in before decisions are announced. No cheating. No hindsight. Just forecasting skill.

62
FDA Events Tracked
27
Predictions Made
Models Compared
Next FDA Decision
6days(Feb 8)

Clemidsogene lanparvovec (RGX-121)

Regenxbio Inc • BLA

FDA decision on clemidsogene lanparvovec for the treatment of Mucopolysaccharidosis II (MPS II)

Gene Therapy - MPS II
Model Predictions
Claude
✓ Approve
GPT-5.2
✗ Reject
Grok
✓ Approve
FDA
Actual
Pending

AI Prediction Leaderboard

LEADING
Claude Opus 4.5
1/1 correct
100%
Avg. confidence: 81%
Grok 4
1/1 correct
100%
Avg. confidence: 92%
GPT-5.2
0/1 correct
0%
Avg. confidence: 78%

Each model gets the same trial data and research. Learn more →

Upcoming FDA Decisions

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Clemidsogene lanparvovec (RGX-121)
Regenxbio Inc
PENDING
Feb 8•BLA▼
Claude
GPT
Grok
KEYTRUDA
Merck & Co Inc.
PENDING
Feb 20•sBLA▼
Claude
GPT
Grok
INQOVI
Otsuka Holdings Co., Ltd.
PENDING
Feb 25•sNDA▼
Claude
GPT
Grok
ET-600
Eton Pharmaceuticals, Inc
PENDING
Feb 25•NDA▼
Claude
GPT
Grok
TransCon CNP
Ascendis Pharma A/S
PENDING
Feb 28•NDA▼
Claude
GPT
Grok

Past FDA Decisions

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Anaphylm
Aquestive Therapeutics Inc.
APPROVED
Jan 31•NDA▼
Claude
GPT
Grok
Leniolisib
Pharming Group N.V.
APPROVED
Jan 31•sNDA▼
Claude
GPT
Grok