IDE-397

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, provided 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. "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: . About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: i) the potential therapeutic benefits of IDEAYA therapeutics; (ii) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts, including those at medical conferences; (iii) the potential and timing for an accelerated approval filing for darovasertib; (iv) the timing of darovasertib in three Phase 3 registrational trials across all stages of UM; (v) the utilization of OS data to support a potential full approval filing for darovasertib; (vi) the timing of initiating registrational studies and other clinical trials for IDEAYA therapeutics; (vii) the timing of patient enrollments in clinical trials; (viii) the timing of IND submissions for IDEAYA therapeutics; and (iv) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its current operating plan. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo