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Ideaya Biosciences Inc (IDYA)

(10% Negative) Ideaya Biosciences Inc (IDYA) Announces Delay in population Development Timeline Due to Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Jan. 29, 2026, 8:58 p.m.

    📋 Ideaya Biosciences Inc (IDYA) - Clinical Trial Update

    Filing Date: 2026-01-12

    Accepted: 2026-01-12 06:05:20

    Event Type: Clinical Trial Update

    Event Details:

    Ideaya Biosciences Inc (IDYA) Announces Clinical Trial Update Ideaya Biosciences Inc (IDYA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: population
    • Clinical Stage: clinical trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process
    • Collaboration: IDEAYA Biosciences, Inc.
      • Targeting the Primary Driver of Disease Oral, selective inhibitor of PKC, the key oncogenic pathway in >95% of UM patients Activating mutations in GNAQ/11 proteins result in PKC overactivation and tumor cell growth Blocking PKC with darovasertib exploits a common weakness in all UM tumors In metastatic UM (mUM), darovasertib is combined with crizotinib, an oral inhibitor of the cMET pathway, which is believed to play a central role in metastatic spread This combination has the potential to improve survival in mUM, regardless of HLA*A2 status A daily, all-oral targeted regimen has the potential to improve compliance, treatment outcomes and quality of life for UM patients PKC = protein kinase C, HGF = hepatocyte growth factor Primary UM Metastatic UM Cancer cell growth and survival GNAQ / 11* PKC Darovasertib cMET Pathway activations by mutations in GNAQ/11 Pathway activations by liver HGF Crizotinib HGF HGF HGF * Activating mutations in GNAQ/11 Robust clinical development plan across the uveal melanoma patient journey Darovasertib Has Potential To Be the First Targeted Therapy for All Stages of UM PFS = progression free survival, OS = overall survival , AA = accelerated approval, NCCN = national comprehensive cancer network Neoadjuvant Adjuvant Metastatic Uveal Melanoma LIMITED THERAPIES Save the eye, preserve vision Prevent relapse or delay progression Diagnosis Primary local therapy Metastasis Progression NO APPROVED THERAPIES Primary Uveal Melanoma Darovasertib monotherapy (Phase 3) Shrink tumor prior to: - Enucleation - Plaque brachytherapy Target enrollment completion H1’ 27 Darovasertib + crizotinib (Phase 3) Manage tumor burden and potential relapse post-primary local therapy Trial initiation H1’26 Darovasertib + crizotinib (Phase 2/3) PFS: supports U.S. AA filing OS: supports full approval Enrollment complete Darovasertib + crizotinib (Phase 2) Includes HLA*A2+ for pot’l NCCN/Compendia listing Currently enrolling HLA*A2-negative HLA*A2-positive Prolong survival and quality of life Orphan Drug Designation in UM1; Fast Track Designation in MUM; Breakthrough Therapy Designation2 (1) Orphan Drugs benefit from certain tax credits and may be excluded from certain mandatory price negotiation provisions of the 2022
      • Targeting Phase 3 initiation in H1 ‘26 Primary UM (Localized disease in the eye) Metastatic UM (Systemic disease) > 3,000 diagnosed in the U.S. per year > 10,000 globally per year1 ~50% progress to metastatic disease Patients face severe consequences with limited treatment options at all stages of disease (1) Estimated based on Helgadottir et. al., Appl of Clin Genet (2016
      • Targeting of Multiple Solid Tumor Indications Indication(s) Target Phase 1 Collaboration partners Phase 2 Phase 3 / Potential Registrational IDE275 Next Generation Therapies IDE574 Werner helicase KAT6/7 MSI-high CRC, endometrial, ovarian Breast, NSCLC 4 MTAP-deleted NSCLC and UC + Trodelvy combination MTAP Pathway IDE397 IDE892 MAT2A PRMT5 MTAP-deleted NSCLC + IDE397 combination Pending IDE892 monotherapy escalation into cohort 2 (Greater China rights) 3 IDE705 Pol θ helicase + TOP1 ADC combos Monotherapy: SCLC, NEC, DLL3+ tumors SCLC, NEC, DLL3+ tumors + IDE161 combination NSCLC, CRC, breast, ovarian, HNSCC ADC+DDR Combos IDE849 (SHR-4849

    🔬 Clinical Development Pipeline (Ideaya Biosciences Inc):

    Product Type Development Stage Therapeutic Area Source
    IDE161 DRUG Phase PHASE1 Small-cell Lung Cancer ClinicalTrials.gov
    IDE892 DRUG Phase PHASE1 NSCLC Adenocarcinoma ClinicalTrials.gov
    Ipilimumab DRUG Phase PHASE2 Metastatic Uveal Melanoma ClinicalTrials.gov
    Primary Local Therapy PROCEDURE Phase PHASE3 Uveal Melanoma ClinicalTrials.gov
    Dacarbazine DRUG Phase PHASE2 Metastatic Uveal Melanoma ClinicalTrials.gov
    Nivolumab DRUG Phase PHASE2 Metastatic Uveal Melanoma ClinicalTrials.gov
    Pembrolizumab DRUG Phase PHASE1 Advanced or Metastatic Solid Tumors ClinicalTrials.gov
    IDE397 DRUG Phase PHASE1 NSCLC Adenocarcinoma ClinicalTrials.gov
    Darovasertib DRUG Phase PHASE2 Uveal Melanoma ClinicalTrials.gov
    IDE849 DRUG Phase PHASE1 Small-cell Lung Cancer ClinicalTrials.gov
    Crizotinib DRUG Phase PHASE1 Metastatic Uveal Melanoma ClinicalTrials.gov
    Binimetinib DRUG Phase PHASE1 Metastatic Uveal Melanoma ClinicalTrials.gov
    IDE196 DRUG Phase PHASE1 Metastatic Uveal Melanoma ClinicalTrials.gov
    IDE-161 DRUG Phase PHASE1 Advanced or Metastatic Solid Tumors ClinicalTrials.gov
    durvalumab DRUG Phase PHASE1 Small-cell Lung Cancer ClinicalTrials.gov
    Sacituzumab govitecan DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    Paclitaxel DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    Docetaxel DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    AP601 DRUG Phase PHASE1 Solid Tumours ClinicalTrials.gov
    doxecitine and doxribtimine DRUG Phase PHASE2 Thymidine Kinase 2 Deficiency ClinicalTrials.gov
    fenfluramine DRUG Phase PHASE3 Dravet Syndrome ClinicalTrials.gov
    AP505 DRUG Phase PHASE1 Advanced Solid Tumors ClinicalTrials.gov
    PD-1 inhibitor BIOLOGICAL Phase PHASE1 Neoplasms, Colorectal ClinicalTrials.gov
    GSK4418959 DRUG Phase PHASE1 Neoplasms, Colorectal ClinicalTrials.gov
    fenfluramine HCl DRUG Phase PHASE1 Healthy Study Participants ClinicalTrials.gov
    bupropion DRUG Phase PHASE1 Healthy Study Participants ClinicalTrials.gov
    metformin DRUG Phase PHASE1 Healthy Study Participants ClinicalTrials.gov
    midazolam DRUG Phase PHASE1 Healthy Study Participants ClinicalTrials.gov
    AP203 DRUG Phase PHASE1 Locally Advanced or Metastatic Solid Tumors ClinicalTrials.gov
    AP402 (Part 2 Dose Expansion) DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    AP402 (Part 1 Dose esclation) DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Ideaya Biosciences Inc
    • Ticker Symbol: IDYA

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