IDEAYA Biosciences, Inc. 8-K

What Happened

• IDEAYA Biosciences (IDYA) announced a business update on January 11, 2026 and said it will review these items at the J.P. Morgan Healthcare Conference on January 12, 2026. The company outlined 2026 corporate objectives and timelines to advance multiple registrational clinical programs, including darovasertib (in uveal melanoma) and IDE849 (a DLL3 TOP1 ADC).
• Key near-term milestones include topline progression-free survival (PFS) results from the randomized Phase 2/3 OptimUM-02 trial (darovasertib + crizotinib in first-line HLA*A2‑negative metastatic uveal melanoma) expected in Q1 2026, and plans to initiate or advance several trials across ADC + DNA damage response, MTAP pathway programs, and next-generation therapies. The company reported approximately $1.1 billion in cash, cash equivalents and marketable securities as of September 30, 2025.

Key Details

• Topline PFS readout expected Q1 2026 from OptimUM-02 based on the first 130 PFS events in the randomized Phase 2b/3 portion (~313 patients randomized 2:1); a positive result could support a potential accelerated approval filing in the U.S.
• OptimUM-02 full enrollment of 437 patients was completed by December 2025; overall survival (OS) data are expected to support a full approval filing in first-line HLA*A2‑negative metastatic UM.
• IDE849 (DLL3 TOP1 ADC) is targeted to begin a monotherapy registrational study in second-line/refractory small cell lung cancer and/or neuroendocrine carcinomas by the end of 2026; several other trials (IDE034, IDE161, IDE892, IDE574) have planned starts in H1–H2 2026.
• Cash position ≈ $1.1 billion as of Sept 30, 2025; company expects these resources to fund the current operating plan into 2030.

Why It Matters

• Near-term clinical readouts (OptimUM-02 PFS in Q1 2026) represent the most immediate regulatory and commercial catalyst: a positive topline could enable an accelerated approval pathway for darovasertib.
• Advancement to multiple registrational Phase 3 trials and broader development across uveal melanoma and ADC programs shows the company is progressing key programs that could drive future value if trials succeed.
• A reported cash runway into 2030 reduces immediate financing risk and supports planned trial starts and commercial readiness activities with partner Servier.
• The filing contains forward-looking statements about timing and outcomes; investors should note these are subject to clinical, regulatory and business risks described in IDEAYA’s SEC filings.