On January 11, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST.

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"2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma – one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

2026 Corporate Objectives

Darovasertib in uveal melanoma (UM)

Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 ’26
Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States
Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 ’26
OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM
OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 ’27
OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 ’26
Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 ’26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset
Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations

IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026
IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 ’26
IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 ’26
MTAP Pathway

IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026
IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 ’26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 ’26
Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA’s dual KAT6/7 inhibitor
Next Generation Therapies

IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 ’26
Corporate

~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030
Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier
IDEAYA’s updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: View Source

(Press release, Ideaya Biosciences, JAN 11, 2026, View Source [SID1234661924])