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Dupixent (dupilumab)

Sanofi / Regeneron · $REGN
Standard Review Fast Track sBLA
PDUFA Date
February 28, 2026
Date Status
44d 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
PDUFA date was February 28, 2026

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$740.02 +33.53%
+$185.84 today
Day: $738.57 – $756.90
Market Cap
N/A
Shares out: 103.90M
Float: 98.55M
52-Week Range
$476.49
$821.11
Current price is at 76% of 52-week range
Avg Volume
719K
Beta
0.40
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

Allergic fungal rhinosinusitis (AFRS) — adults and children 6+

Key Notes

FDA APPROVED February 26, 2026 — 2 days ahead of PDUFA target date. Expands Dupixent label to include allergic fungal rhinosinusitis (AFRS) in adults and children aged 6+.
⚠️ 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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