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Leqembi (lecanemab)

Eisai / Biogen · $BIIB
Standard Review Accelerated Approval sNDA
PDUFA Date
July 25, 2026
Date Status
15d ago (past)
Review Type
Standard (10 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: July 13, 2026
FDA Approved on 2026-07-13 (BLA761375). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761375

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$207.94 +62.77%
+$80.19 today
Day: $204.16 – $208.31
Market Cap
N/A
Shares out: 147.75M
Float: 144.76M
52-Week Range
$127.71
$219.72
Current price is at 87% of 52-week range
Avg Volume
1.27M
Beta
0.16
vs. S&P 500
Sector
Healthcare
Drug Manufacturers - General
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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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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