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zenocutuzumab

Merus NV · $MRUS

Standard Review Phase 2 Breakthrough Therapy

PDUFA Date

June 1, 2026

Time Remaining

69 days

Review Type

Standard (10 mo)

Indication

NRG1 fusion-positive NSCLC and pancreatic cancer

Key Notes

eNRGy Phase 2 data presentation expected Q2 2026. Zenocutuzumab (MCLA-128) is a HER2/HER3 bispecific antibody for NRG1 fusion+ cancers. Rolling BLA submission ongoing — NDA/BLA decision expected late 2026.

⚠️ 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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