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BT8009

Bicycle Therapeutics · $BCYC

Standard Review Phase 2 Fast Track

PDUFA Date

September 1, 2026

Time Remaining

161 days

Review Type

Standard (10 mo)

Indication

Metastatic urothelial carcinoma (Nectin-4 targeted)

Key Notes

DUET-2 Phase 2 trial data expected Q3 2026. BT8009 is a Nectin-4–targeted Bicycle Toxin Conjugate (BTC) — differentiated from ADCs with potentially improved tumor penetration in bladder cancer.

⚠️ 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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