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Leqembi (lecanemab)

Eisai / Biogen · $BIIB

Standard Review Accelerated Approval sNDA

PDUFA Date

July 25, 2026

Time Remaining

123 days

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical sNDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Subcutaneous formulation — early Alzheimer's disease

Key Notes

Subcutaneous version of IV Leqembi for more convenient at-home dosing.

⚠️ 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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