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orforglipron

Eli Lilly · $LLY

Priority Review Fast Track Breakthrough Therapy NDA

PDUFA Date

April 10, 2026

Time Remaining

17 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical NDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Obesity / overweight (oral GLP-1 receptor agonist — once-daily pill)

Key Notes

NDA submitted 2025. FDA granted Priority Review via National Priority Review Voucher from FDA Commissioner Makary. PDUFA date April 10, 2026. Four positive Phase 3 ATTAIN trials. First oral non-peptide GLP-1 agonist — major convenience advantage over injectable GLP-1s.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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