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pozelimab

Regeneron · $REGN
Priority Review Breakthrough Therapy Orphan Drug BLA
PDUFA Date
October 20, 2026
Date Status
10d ago (past)
Review Type
Priority (6 mo)
93%
Baseline PoA
Orphan/rare disease designation approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

⏳
Outcome Not Yet Recorded
PDUFA date was October 20, 2026 · This entry hasn't been updated with the FDA decision yet.
↗ Check FDA Drug Approval Database

Live Company Data NMS

Updated 17m ago · Data: FMP
Current Price
$818.77 +25.40%
+$165.86 today
Day: $811.63 – $828.19
Market Cap
N/A
Shares out: 101.14M
Float: 95.85M
52-Week Range
$591.52
$859.34
Current price is at 85% of 52-week range
Avg Volume
719K
Beta
0.15
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

VEXAS syndrome (complement C5 inhibitor)

Key Notes

First potential targeted therapy for VEXAS syndrome, a rare inflammatory disease caused by somatic UBA1 mutations. Pozelimab (anti-C5 antibody) BLA under Priority Review with a PDUFA target action date of October 20, 2026.
⚠️ 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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