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IDYA biotech catalysts & pipeline

IDEAYA BIOSCIENCES INC · Data as of 2026-10-25

Upcoming catalysts

darovasertib — NDA/BLA submission

H2 2026

IDEAYA is submitting a new drug application (NDA) for darovasertib in combination with crizotinib for patients with first line metastatic uveal melanoma under the oncology center of excellence (OCE) real-time oncology review (RTOR) program and expects to complete the NDA submission in the second half of 2026.
Source filing

IDE034 (B7H3/PTK7 bispecific TOP1i ADC) — Initial data

Sep 2026–Apr 2027

IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data.
Source filing

darovasertib combination — Interim data

mid-2027

IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027.
Source filing

IDE397 — Conference presentation

2026

IDE397 (MAT2A): planning to provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026.
Source filing

darovasertib — Conference presentation

Oct 23–Oct 27

Updated clinical data will also be presented at ESMO from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib.
Source filing

darovasertib combination — Conference presentation

Oct 23–Oct 27

The company plans to present updated ORR, PFS and OS results from approximately 85 efficacy-evaluable HLA*A2:01-positive patients, including both first line and pre-treated patients, at the 2026 European Society of Medical Oncology (ESMO) Congress taking place in October in Madrid, Spain.
Source filing

IDE849 (DLL3 TOP1i ADC) — Conference presentation

Oct 23–Oct 27

Updated data from Hengrui-sponsored Phase 1 trial of IDE849 (DLL3 TOP1 ADC) in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) patients to be presented at ESMO
Source filing

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