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zovegalisib (RLY-2608)

Relay Therapeutics · $RLAY

Standard Review Phase 2 Fast Track Breakthrough Therapy

PDUFA Date

May 15, 2026

Time Remaining

52 days

Review Type

Standard (10 mo)

Indication

PIK3CA-mutant HR+/HER2- metastatic breast cancer

Key Notes

SERENA-PI3K trial Phase 2 readout. Previously called RLY-2608; renamed zovegalisib after FDA Breakthrough Therapy designation. Initial Phase 1/2 data at ESMO TAT March 16, 2026 (presented). Full Phase 2 readout at ASCO 2026 expected. Breast cancer triplet data and frontline Phase 3 plans also expected in 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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