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bezuclastinib

Cogent Biosciences · $COGT

Standard Review Phase 2 Breakthrough Therapy Orphan Drug

PDUFA Date

June 15, 2026

Time Remaining

83 days

Review Type

Standard (10 mo)

Indication

Advanced systemic mastocytosis (AdvSM)

Key Notes

APEX trial Phase 2 data. Bezuclastinib is a highly selective KIT D816V inhibitor for systemic mastocytosis. Expected presentation at a major oncology conference mid-2026. NDA filing planned following data.

⚠️ 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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