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Indication
Essential thrombocythemia (ET) — label expansion from polycythemia vera
Key Notes
sBLA PDUFA August 30, 2026 (standard review). BESREMi is already FDA-approved for polycythemia vera (PV). sBLA supported by Phase 3 SURPASS-ET trial and confirmatory EXCEED-ET Phase 2b data. Essential thrombocythemia is a rare MPN driven by platelet overproduction — no new FDA-approved therapies for over 20 years. NCCN guidelines already include ropeginterferon for ET treatment. PharmaEssentia listed on Taiwan Stock Exchange (TWSE: 6446) — no US ticker.
⚠️ 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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