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nipocalimab

Johnson & Johnson · $JNJ
Priority Review Breakthrough Therapy Orphan Drug BLA
PDUFA Date
February 1, 2026
Time Remaining
51d ago
Review Type
Priority (6 mo)
90%
Baseline PoA
Historical BLA
approval rate
Dynamic PoA
Coming soon
xAI Sentiment

Indication

Hemolytic disease of the fetus and newborn (HDFN)

Key Notes

Anti-FcRn antibody for the prevention of HDFN. Rare pregnancy complication.
⚠️ 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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