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pozelimab

Regeneron · $REGN

Priority Review Breakthrough Therapy Orphan Drug BLA

PDUFA Date

October 1, 2026

Time Remaining

191 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

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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