IDEAYA Biosciences, Inc.

IDEAYA Biosciences, Inc. is an oncology-focused precision medicine company dedicated to the discovery, development, and commercialization of transformative therapies for cancer. The company's mission is to alter the course of disease and improve clinical outcomes for patients by integrating expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers. IDEAYA Biosciences is headquartered in South San Francisco, California.

The company's pipeline is primarily focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications. Key product candidates include darovasertib (IDE196), a PKC inhibitor for genetically-defined cancers such as uveal melanoma; IDE397, a MAT2A inhibitor targeting tumors with MTAP gene deletion; IDE161, a PARG inhibitor for tumors with homologous recombination deficiency (HRD); and IDE849, a DLL3 TOP1 ADC for small cell lung cancer and neuroendocrine cancer. Other programs include IDE574, a KAT6/7 dual inhibitor, and IDE275 (GSK959), a Werner Helicase inhibitor developed in collaboration with GlaxoSmithKline.

In recent news, the U.S. Food and Drug Administration (FDA) has agreed to review IDEAYA's New Drug Application (NDA) for darovasertib in combination with crizotinib for first-line HLA-A2-negative metastatic uveal melanoma under the Real-Time Oncology Review (RTOR) program, following positive Phase 2/3 OptimUM-02 trial results. Full data from this trial are expected to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2026. Yujiro S. Hata serves as the President, Chief Executive Officer, and Founder, with Dr. Theodora Ross appointed as Chief Development Officer in February 2026. The company maintains a strong market position as a clinical-stage entity with a deep pipeline and a cash runway anticipated to fund operations into 2029 or 2030.

Latest updates

IDEAYA Expedites Uveal Melanoma Drug Review via FDA’s RTOR Program

Event summary

  • IDEAYA Biosciences is seeking FDA approval for darovasertib in combination with crizotinib for 1L HLA*A2-negative metastatic uveal melanoma (mUM).
  • The OptimUM-02 Phase 2/3 trial demonstrated a 58% reduction in disease progression risk (HR=0.42) and a 6.9-month improvement in median progression-free survival (PFS).
  • IDEAYA will initiate the RTOR submission process in May 2026, with full NDA filing expected in H2 2026.
  • The FDA has agreed to review the application under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.

The big picture

IDEAYA’s accelerated review pathway underscores the growing pressure on regulatory bodies to expedite approvals for therapies targeting rare cancers with significant unmet need. The RTOR program, while intended to streamline the process, introduces a degree of scrutiny and requires robust data to maintain its efficiency. Success for IDEAYA could set a precedent for other precision oncology programs seeking expedited review, while failure could highlight the challenges of the RTOR process.

What we're watching

Regulatory Speed
The success of RTOR in accelerating the approval timeline for darovasertib will be a key test case for the program’s efficacy and broader adoption within the FDA.
OS Data
The maturity of overall survival (OS) data, currently showing an early trend of improvement, will be critical in determining the drug's long-term clinical value and potential market uptake.
Competitive Landscape
The emergence of darovasertib/crizotinib will likely intensify competition within the limited treatment options for HLA*A2-negative mUM, potentially impacting pricing and market share.

IDEAYA's Uveal Melanoma Trial Data to Shape First-Line Treatment Landscape

Event summary

  • IDEAYA Biosciences will present complete data from the Phase 2/3 OptimUM-02 trial at ASCO 2026 on June 1st.
  • The trial evaluated darovasertib in combination with crizotinib as a first-line treatment for HLA*A2-negative metastatic uveal melanoma.
  • Dr. Marlana Orloff of Thomas Jefferson University Hospital will present the findings.
  • The presentation will include data not previously disclosed in the topline release.

The big picture

Uveal melanoma is a rare and aggressive cancer with limited treatment options, representing a significant unmet medical need. IDEAYA's trial, targeting a specific HLA*A2-negative patient population, reflects a growing trend towards precision oncology and biomarker-driven therapies. Positive results could establish a new standard of care and provide a valuable asset for IDEAYA, but failure to demonstrate efficacy could significantly impact the company's pipeline and valuation.

What we're watching

Efficacy Threshold
The data presented will determine if the combination therapy demonstrates a clinically meaningful benefit over investigator's choice, a critical factor for adoption.
Biomarker Validation
How the HLA*A2-negative selection criteria impacts the trial's success and whether IDEAYA can expand the indication based on further biomarker analysis will be key.
Regulatory Pathway
The strength of the data will influence the FDA's assessment of the therapy's potential, impacting the timeline and likelihood of approval.

IDEAYA, Servier's Uveal Melanoma Trial Data Signals Potential First-Line Shift

Event summary

  • IDEAYA Biosciences and Servier announced positive topline results from the Phase 2/3 OptimUM-02 trial evaluating darovasertib in combination with crizotinib for first-line HLA-A*02:01-negative metastatic uveal melanoma.
  • The combination demonstrated a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months with investigator choice therapy (ICT) (HR: 0.42; p < 0.0001).
  • The combination achieved a 37.1% overall response rate (ORR) compared to 5.8% with ICT (p < 0.0001), including 5 complete responses.
  • IDEAYA plans to submit an NDA to the FDA in H2'26, potentially seeking accelerated approval.
  • The trial enrolled 313 patients as of January 23, 2026, with the ICT arm composed of 76% ipilimumab plus nivolumab and 24% pembrolizumab.

The big picture

The OptimUM-02 results represent a significant advancement in the treatment of HLA-A*02:01-negative metastatic uveal melanoma, a rare cancer with limited therapeutic options. This success validates IDEAYA’s precision medicine approach and strengthens its partnership with Servier, which is expanding its oncology portfolio. The trial’s design, utilizing ICT as a control, highlights the unmet need and potential for disruptive therapies in this niche market, but also introduces complexities in demonstrating comparative effectiveness.

What we're watching

Regulatory Risk
The FDA’s accelerated approval pathway for darovasertib combination will hinge on the maturity of the overall survival (OS) data and the strength of the PFS benefit, potentially impacting commercial timelines.
Competitive Landscape
The adoption rate of darovasertib combination will be influenced by the continued performance and pricing of existing therapies like ipilimumab/nivolumab and pembrolizumab, particularly given the trial’s ICT arm composition.
Market Access
Given the rarity of HLA-A*02:01-negative mUM, IDEAYA and Servier will need to demonstrate a compelling value proposition to payers to ensure broad market access and reimbursement for the combination therapy.

IDEAYA's Uveal Melanoma Trial Results to Shape Precision Oncology Outlook

Event summary

  • IDEAYA Biosciences will announce topline results from Phase 2/3 trial OptimUM-02 on April 13, 2026.
  • The trial evaluates darovasertib in combination with crizotinib for first-line HLA*A2-negative metastatic uveal melanoma.
  • The announcement will be a joint IDEAYA and Servier press release, accompanied by a conference call and webcast.
  • The call will feature IDEAYA management and a key opinion leader.

The big picture

Uveal melanoma is a rare and aggressive cancer with limited treatment options, representing a significant unmet need. IDEAYA's trial represents a pivotal moment for the company and the broader field of precision oncology, as it tests a targeted approach based on HLA*A2 status. The results will inform the development of other targeted therapies and potentially reshape treatment paradigms for this difficult-to-treat cancer.

What we're watching

Clinical Efficacy
The trial's success hinges on demonstrating statistically significant and clinically meaningful improvements in overall survival or progression-free survival, which will dictate the drug's regulatory pathway and commercial viability.
Partner Dynamics
Servier's involvement suggests a shared financial risk and reward, and the nature of their collaboration will be scrutinized to assess the long-term strategic alignment between the two companies.
Market Adoption
Given the rarity of uveal melanoma, the commercial success of darovasertib/crizotinib will depend on IDEAYA's ability to navigate reimbursement challenges and establish a robust patient identification and access program.

IDEAYA Initiates Phase 1 Trial for Novel KAT6/7 Inhibitor Targeting Solid Tumors

Event summary

  • IDEAYA Biosciences initiated a Phase 1 dose escalation trial for IDE574, a dual inhibitor of KAT6/7.
  • The trial will evaluate IDE574 as a monotherapy in solid tumor patients, including breast, prostate, colorectal, and lung cancer.
  • IDE574 demonstrates nanomolar potency and selectivity against KAT6/7, with preclinical data suggesting superior efficacy compared to KAT6-selective inhibitors.
  • The drug targets epigenetic mechanisms implicated in cancer cell survival and resistance to hormone-based therapies, particularly in breast cancer with ESR1 mutations.

The big picture

IDEAYA’s entry into Phase 1 with IDE574 represents a strategic shift towards targeting epigenetic mechanisms in cancer, a field gaining traction as resistance to traditional therapies becomes increasingly prevalent. The focus on dual KAT6/7 inhibition, rather than selective KAT6 inhibition, suggests a deeper understanding of cancer biology and a potential advantage in efficacy. Success hinges on demonstrating clinical benefit with a novel target and navigating the complexities of epigenetic drug development.

What we're watching

Clinical Efficacy
The trial's initial focus on monotherapy will reveal if IDE574 demonstrates sufficient activity to warrant further development, or if combination strategies are essential for meaningful clinical impact.
Regulatory Pathway
Given the novel mechanism of action, the FDA's acceptance of IDE574's clinical trial design and potential for accelerated approval will be a key indicator of its long-term prospects.
Combination Potential
The company's stated intention to explore combinations with its existing pipeline will determine if IDE574 can synergize with other assets and broaden its therapeutic applicability.

IDEAYA Initiates Phase 1 Combo Trial Targeting DLL3 in Multiple Cancers

Event summary

  • IDEAYA Biosciences has begun a Phase 1 clinical trial combining IDE849 (DLL3-targeting ADC) and IDE161 (PARG inhibitor) in patients with DLL3-upregulated solid tumors.
  • The trial will evaluate the combination in small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.
  • Preliminary data from IDE849 monotherapy shows multiple partial responses (PRs) in SCLC patients, including 3 out of 4 pre-treated with IMDELLTRA® at 2.4 mg/kg.
  • IDE161 is designed to enhance the efficacy of TOP1 ADCs by preventing PARG-mediated DNA repair, leading to accumulation of DNA damage.
  • Clinical data updates for both IDE849 monotherapy and the combination with IDE161 are expected in H2 2026.

The big picture

IDEAYA's strategy of combining targeted therapies, particularly ADCs with PARG inhibitors, represents a growing trend in oncology to overcome resistance and improve treatment durability. The focus on DLL3, a target with limited expression in normal tissues, aims to minimize off-target effects. Success here could validate IDEAYA’s synthetic lethality approach and potentially expand its pipeline beyond the initial indications.

What we're watching

Clinical Efficacy
The observed PRs in SCLC patients pre-treated with IMDELLTRA® warrant close monitoring; the combination's efficacy will need to significantly exceed existing therapies to drive adoption.
Regulatory Pathway
IDEAYA's plans to initiate a registrational study by year-end hinge on the Phase 1 data; a clear regulatory pathway for the combination will be crucial for long-term value.
Partner Dynamics
The consistency of IDEAYA's data with that of Jiangsu Hengrui Pharmaceuticals will be a key indicator of collaboration effectiveness and potential future revenue sharing.

IDEAYA Presents Early Data on Novel Cancer Therapies at AACR

Event summary

  • IDEAYA Biosciences will present preclinical data at the AACR Annual Meeting (April 17-22, 2026) for three clinical-stage programs: IDE034, IDE574, and IDE892.
  • IDE034 is a bi-specific ADC targeting PTK7 and B7-H3; IDE574 inhibits KAT6/7; IDE892 inhibits PRMT5 and is designed for MTAP-deleted cancers in combination with IDE397.
  • Phase 1 clinical trials are underway to assess safety, tolerability, pharmacokinetics, and efficacy across lung, colorectal, pancreatic, breast, and prostate cancer indications.
  • The poster presentations will be available on IDEAYA's website following the meeting.

The big picture

IDEAYA's focus on first-in-class therapies targeting DNA damage repair and epigenetic pathways reflects a broader trend in oncology towards precision medicine and overcoming drug resistance. The company’s pipeline, while early-stage, represents a significant investment in novel therapeutic modalities, particularly ADCs and targeted small molecules. Success hinges on demonstrating clinical efficacy and navigating the inherent risks of early-stage drug development.

What we're watching

Clinical Efficacy
The initial Phase 1 data presented at AACR will be crucial in determining the therapeutic potential of these programs, particularly given the broad range of cancer types being targeted.
Combination Strategy
The planned combination of IDE892 with IDE397 highlights a strategic focus on synergistic therapies; success will depend on demonstrating a clear benefit beyond monotherapy.
Biomarker Selection
IDE574’s efficacy is tied to biomarker-selected indications, suggesting that patient stratification will be critical for demonstrating clinical benefit and guiding future development.

IDEAYA Initiates Phase 1 Trial for PRMT5 Inhibitor, Deprioritizes Trodelvy Combination

Event summary

  • IDEAYA Biosciences initiated a Phase 1 clinical trial for IDE892, a PRMT5 inhibitor, targeting MTAP-deleted solid tumors including NSCLC and PDAC.
  • The trial will evaluate IDE892 as a monotherapy and in combination with IDE397 (MAT2A inhibitor), with combination studies planned to begin mid-2026.
  • IDEAYA is deprioritizing combination activities with Trodelvy and Gilead, citing a strategic focus on its MTAP-deleted and CDKN2A pipeline.
  • The company expects to nominate a first-in-class CDKN2A development candidate in H2 2026 and initiate an IND in H1 2027.
  • IDE892 demonstrates ~1,400-fold selective binding to MTA-PRMT5 and single-digit nanomolar potency in MTAP-deleted cell lines.

The big picture

IDEAYA's decision to deprioritize Trodelvy reflects a broader trend in precision oncology towards greater reliance on internally developed assets and a focus on synergistic combinations. The company's strategy hinges on exploiting synthetic lethal vulnerabilities in MTAP-deleted tumors, a relatively rare but underserved patient population. Success will depend on demonstrating clinical efficacy with its pipeline and navigating the complexities of biomarker-driven patient selection.

What we're watching

Clinical Efficacy
The Phase 1 trial results will be critical in determining IDE892's therapeutic window and potential for clinical benefit as a monotherapy and in combination with IDE397, particularly given the limited treatment options for MTAP-deleted tumors.
Pipeline Focus
The deprioritization of Trodelvy combination studies signals a shift in IDEAYA's strategy; the success of its internally developed pipeline, especially the CDKN2A program, will be key to justifying this redirection.
Regulatory Pathway
The speed with which IDEAYA can advance its CDKN2A program to IND submission, and subsequently clinical trials, will depend on preclinical data and could influence investor sentiment regarding the company's long-term prospects.

IDEAYA Initiates Phase 1 Trial for Novel B7H3/PTK7 ADC, Triggers $5M Milestone

Event summary

  • IDEAYA Biosciences initiated a Phase 1 dose escalation/expansion trial for IDE034, a B7H3/PTK7 bispecific TOP1 antibody-drug conjugate (ADC).
  • The trial will evaluate IDE034 as a monotherapy and in combination with IDEAYA’s PARG inhibitor, IDE161.
  • B7H3/PTK7 co-expression is estimated to occur in 30-40% of solid tumor types, including lung, breast, ovarian, and colorectal cancers.
  • Enrollment of the first patient triggers a $5 million milestone payment to IDEAYA from Biocytogen.

The big picture

IDEAYA’s strategy of combining targeted ADCs with DNA damage response inhibitors represents a growing trend in oncology, aiming to overcome resistance mechanisms and improve treatment durability. The Phase 1 trial for IDE034 marks a key step in validating this approach, and its success could significantly expand IDEAYA’s pipeline and market potential. The company’s focus on first-in-class therapies positions it to capture a significant share of the precision oncology market, but also carries inherent development risks.

What we're watching

Clinical Efficacy
The trial's early data on safety, tolerability, and preliminary efficacy will be crucial in determining IDE034's potential as a monotherapy and in combination with IDE161, given the preclinical synergy observed.
Combination Strategy
The success of the DDR pathway inhibition strategy with IDE161 will hinge on whether the synergistic effect observed in preclinical models translates to meaningful clinical benefit in patients.
Competitive Landscape
The progress of IDE849, IDEAYA’s DLL3 TOP1 ADC, will influence investor sentiment and potentially impact the perceived value and development timeline for IDE034.

IDEAYA Appoints AbbVie Exec to Drive Oncology Pipeline Development

Event summary

  • IDEAYA Biosciences appointed Dr. Theodora (Theo) Ross as Chief Development Officer, a newly created role.
  • Dr. Ross previously served as Vice President, Head of Early Oncology R&D and Site Head for AbbVie’s Bay Area operations.
  • She brings over 30 years of experience in oncology, including roles at Amgen, Merck, and UTSW.
  • Dr. Ross led the advancement of five early-stage oncology programs at AbbVie and was instrumental in the $10 billion acquisition of Immunogen.
  • IDEAYA is focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications.

The big picture

The appointment of a seasoned executive like Dr. Ross signals IDEAYA’s ambition to advance its pipeline and compete in the increasingly crowded precision oncology space. Her experience, particularly her involvement in the Immunogen acquisition, suggests a focus on strategic M&A opportunities to bolster IDEAYA’s asset portfolio. The company’s reliance on synthetic lethality and ADCs positions it within a high-risk, high-reward segment of the biotech industry, demanding rigorous clinical execution.

What we're watching

Execution Risk
Dr. Ross’s success hinges on her ability to rapidly integrate into IDEAYA’s existing R&D structure and accelerate the clinical development of its pipeline candidates.
Pipeline Focus
IDEAYA’s commitment to a focused pipeline, as emphasized by Dr. Ross, will determine whether it can efficiently allocate resources and achieve clinical milestones.
Competitive Landscape
The competitive pressure from established players like AbbVie, Amgen, and Merck will test IDEAYA’s ability to differentiate its therapies and secure market share.

IDEAYA Biosciences Pipeline Advances as Cash Reserves Extend Runway

Event summary

  • IDEAYA Biosciences ended 2025 with ~$1.05 billion in cash, cash equivalents, and marketable securities, projecting funding into 2030.
  • Enrollment is complete for the Phase 2/3 OptimUM-02 trial in HLA*A2-negative metastatic uveal melanoma, with topline results expected by late March 2026.
  • The company plans to initiate a registrational study for IDE849 (DLL3 TOP1 ADC) in 2L+ small cell lung cancer/neuroendocrine carcinoma by year-end 2026.
  • GSK terminated its collaboration agreement with IDEAYA, transferring the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to IDEAYA.

The big picture

IDEAYA’s progress highlights the increasing focus on precision medicine in oncology, with targeted therapies like darovasertib and ADCs like IDE849 representing a shift towards more personalized treatment approaches. The termination of the GSK collaboration, while resulting in the return of assets, underscores the ongoing restructuring within the pharmaceutical industry as companies reassess their portfolios and strategic partnerships. With a significant cash position, IDEAYA is well-positioned to pursue its pipeline ambitions, but execution risk remains a key factor in its long-term success.

What we're watching

Clinical Execution
The topline PFS data from the OptimUM-02 trial will be critical in determining the potential for accelerated approval and the overall viability of darovasertib as a treatment for uveal melanoma.
Pipeline Diversification
IDEAYA’s ability to advance its ADC and MTAP pathway programs, particularly IDE849 and IDE397, will be key to mitigating risk and expanding its therapeutic reach beyond uveal melanoma.
Financial Discipline
The substantial cash reserves will be tested as IDEAYA moves into Phase 3 trials and initiates new programs; management's ability to maintain a long cash runway will be essential for continued operation.

IDEAYA Biosciences to Detail Pipeline Progress at Investor Events

Event summary

  • IDEAYA Biosciences will participate in two virtual investor events in February 2026.
  • The first event, hosted by Citi, is scheduled for February 18, 2026, at 1:00 PM ET, featuring a fireside chat with key executives.
  • A second event, hosted by Evercore ISI, is planned for February 23, 2026, at 12:00 PM ET, with CEO Yujiro Hata and other executives.
  • Webcasts of both events will be available on IDEAYA’s investor relations website and through the conference hosts.

The big picture

IDEAYA’s investor events signal a continued effort to communicate its pipeline progress and financial strategy to the market. The company’s focus on synthetic lethality and ADCs within precision oncology places it within a rapidly evolving and competitive landscape. These events provide a key opportunity to assess management’s outlook and address investor concerns regarding the company’s long-term viability.

What we're watching

Pipeline Visibility
The content of the fireside chats will be critical in assessing the progress of IDEAYA’s pipeline, particularly concerning the timing and results of ongoing clinical trials.
Financial Health
Given the capital-intensive nature of drug development, the discussions around IDEAYA’s financial runway and potential funding strategies will be closely scrutinized.
Competitive Landscape
How IDEAYA positions its synthetic lethality and ADC approaches relative to competitors in the precision oncology space will indicate the company's ability to maintain a differentiated market position.
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