IDE397 — Topline data
2026
Phase 2 readout (+Trodelvy) UC patients (2026)Source filing
IDYA biotech catalysts & pipeline
IDEAYA BIOSCIENCES INC · Data as of 2026-09-08
Upcoming catalysts
darovasertib in combination with crizotinib — NDA/BLA submission
H2 2026
Registrational OptimUM-02 trial of the darovasertib combination in metastatic uveal melanoma (mUM) met its primary endpoint; new drug application (NDA) filing is underway under the real-time oncology review program (RTOR) with completion expected in H2 2026Source 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
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 ESMOSource filing