IDEAYA Biosciences, Inc. IDYA
IDEAYA Biosciences, Inc. (Nasdaq: IDYA) is an oncology drug developer. Its lead program, darovasertib (+ crizotinib), is in Phase 3 for Uveal melanoma (metastatic first line; neoadjuvant; adjuvant). Its next catalyst on record is darovasertib: Updated OptimUM-01 (HLA-A2 positive) data at ESMO (October 2026).
Upcoming catalysts
- October 2026darovasertib — Updated OptimUM-01 (HLA-A2 positive) data at ESMO
We plan to present updated clinical data from this trial at the 2026 European Society for Medical Oncology (ESMO) Congress being held in October in Madrid, Spain.
Next further out: darovasertib — Complete NDA submission (rolling pre-submission under RTOR already begun) for accelerated approval in mUM (H2 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| darovasertib + crizotinib (OptimUM-02, 1L HLA-A2(-) mUM) | Metastatic uveal melanoma | small molecule | Phase 3 |
| darovasertib neoadjuvant (OptimUM-10 Phase 3) | Primary uveal melanoma (neoadjuvant) | small molecule | Phase 3 |
| darovasertib + crizotinib adjuvant (OptimUM-11 Phase 3, with Servier) | Primary uveal melanoma (adjuvant) | small molecule | Phase 3 |
| IDE849 (DLL3 TOP1 ADC) | Small-cell lung cancer, neuroendocrine carcinoma | antibody | Phase 1 |
| IDE892 (PRMT5 MTA-cooperative inhibitor) | MTAP-deleted solid tumors (PDAC, NSCLC) | small molecule | Phase 1 |
| IDE397 (MAT2A inhibitor) | MTAP-deleted solid tumors | small molecule | Phase 1 |
| IDE034 (B7H3/PTK7 bispecific TOP1 ADC) | Solid tumors | antibody | Phase 1 |
| IDE161 (PARG inhibitor) | Solid tumors (with TOP1 ADCs) | small molecule | Phase 1 |
| IDE574 (KAT6/7 dual inhibitor) | Breast, lung, prostate, colorectal cancers | small molecule | Phase 1 |
Recent results and decisions
- Aug 4, 2026started Global Phase 3 OptimUM-11 (~450 pts, adjuvant primary UM, RFS primary endpoint) initiated with Servier.
Following the successful completion of a Type C meeting with the FDA earlier this year, IDEAYA and its partner, Les Laboratoires Servier (Servier), initiated a global Phase 3 registrational trial (OptimUM-11) to evaluate the darovasertib combination in the adjuvant setting of primary uveal melanoma.
Filing - May 5, 2026completed enrollment Enrollment completed (~100 patients) in single-arm Phase 2 OptimUM-01 in HLA*A2-positive mUM.
IDEAYA has completed enrollment of approximately 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib.
Filing - Apr 13, 2026met Phase 2/3 OptimUM-02 met primary PFS endpoint: mPFS 6.9 vs 3.1 months (HR 0.42, p<0.0001) by BICR; ORR 37.1% vs 5.8%.
The darovasertib combination met the trial’s primary endpoint of a statistically significant improvement in median progression-free survival (“PFS”) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (“BICR”).
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.