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· Data: FMP
Current Price
$35.29
-49.08%
$-34.01 today
Day: $35.13 – $35.63
52-Week Range
Current price is at 0% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Indication
Hemophilia A (with or without inhibitors) — monthly/biweekly/weekly subcutaneous prophylaxis
Key Notes
BLA submitted September 29, 2025. PDUFA estimated ~July 29, 2026 (10-month standard review). FVIIIa-mimetic bispecific antibody — competes with approved emicizumab (Hemlibra, Roche). FRONTIER Phase 3 program (FRONTIER1-5): evaluated across dosing schedules (once monthly, biweekly, weekly), age groups, and with/without inhibitors. Flexible subcutaneous pen injector with once-monthly dosing option — key differentiation vs emicizumab's Q1W/Q2W/Q4W dosing. Hemophilia A is a $10B+ global market.
⚠️ 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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