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IDEAYA Advances NDA for Darovasertib+Crizotinib as ESMO Data Support UM Franchise

Nov 3, 2026, 12:02 PM EST1 sourcesAI-analyzed

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Regulatory milestone (NDA RTOR) and strong ESMO data can de-risk the program, potentially unlocking near-term upside; multiple high-profile collaborations add optionality and visibility.

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IDEAYA reports NDA submission for the darovasertib+crizotinib combo in metastatic uveal melanoma, backed by positive ESMO data suggesting broader UM utility across HLA-A*02:01 statuses and lines of therapy. Additional updates include IDE849 DLL3 TOP1 ADC activity in SCLC/NEC and a robust cash runway into 2030, underpinning potential near-term regulatory progress and expanded pipeline opportunities.

NDA for darovasertib+crizotinib in metastatic uveal melanoma submitted in Q3 2026.
ESMO 2026 shows darovasertib potential across UM, independent of HLA-A*02:01 status.
OptimUM-02: combo improves PFS in HLA-A*02:01-negative metastatic UM.
IDEAYA cash $1.151B, runway into 2030; R&D Day on Nov 16 in London.
IDE849 data: SCLC/NEC activity; planned two Phase 3 registrational trials by year-end.

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