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pozelimab

Regeneron · $REGN
Priority Review Breakthrough Therapy Orphan Drug BLA
PDUFA Date
October 1, 2026
Time Remaining
93 days
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

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$631.81 +21.27%
+$110.81 today
Day: $626.86 – $638.30
Market Cap
N/A
52-Week Range
$518.90
$821.11
Current price is at 37% of 52-week range
⚠️ 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 targeted therapy for VEXAS — inflammatory disease caused by UBA1 mutations.
⚠️ 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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