Earnings summaries and quarterly performance for IDEAYA Biosciences.
Executive leadership at IDEAYA Biosciences.
Yujiro Hata
President and Chief Executive Officer
Andres Ruiz Briseno
Chief Accounting Officer
Darrin Beaupre
Chief Medical Officer
Joshua Bleharski
Chief Financial Officer
Michael White
Chief Scientific Officer
Stuart Dorman
Chief Commercial Officer
Board of directors at IDEAYA Biosciences.
Research analysts who have asked questions during IDEAYA Biosciences earnings calls.
Anupam Rama
JPMorgan Chase & Co.
1 question for IDYA
Ben Burnett
Stifel
1 question for IDYA
Charles Zhu
LifeSci Capital, LLC
1 question for IDYA
Joel Beatty
Robert W. Baird & Co.
1 question for IDYA
Maury Raycroft
Jefferies
1 question for IDYA
Tim Chiang
Northland Securities, Inc.
1 question for IDYA
Zegbeh Jallah
Roth Capital Partners
1 question for IDYA
Recent press releases and 8-K filings for IDYA.
- IDEAYA expects top-line results this quarter (Q1 2026) for its lead program, darovasertib, in a registrational study, aiming for potential accelerated approval filing in the U.S..
- The company plans to initiate a registrational study this year (2026) for its DLL3 TOPO-ADC program, ID849.
- IDEAYA has nine clinical stage molecules advancing, with strategic focus areas including extending the durability of TOPO-ADCs, MTAP deletion biology, and KAT6/7 inhibitors.
- IDEAYA expects top-line results this quarter (Q1 2026) from the registrational study for darovasertib in uveal melanoma, aiming for potential accelerated approval filing in the U.S.. The company also plans to initiate three randomized Phase III trials for darovasertib in H1 2026.
- The DLL3 TOPO-ADC program, IDE849, is targeted to enter a registrational study in 2026. In second-line small cell lung cancer, IDE849 showed a confirmed response rate of approximately 70% and a progression-free survival (PFS) of just over six months.
- IDEAYA is focused on MTAP deletion, a patient population found in roughly 15% of solid tumors that currently lacks approved therapies. The company is pursuing multiple strategies in this area, including combinations with MAT2A and PRMT5.
- The company's pipeline includes nine clinical stage molecules, such as the Phase I dual KAT6/7 inhibitor, IDE574, which targets tumor heterogeneity.
- IDEAYA anticipates top-line results this quarter (Q1 2026) from the registrational study for darovasertib, targeting a potential first accelerated approval filing in the U.S. for uveal melanoma.
- The company aims to initiate its first registrational study for the DLL3 TOPO-ADC program (ID849) this year (2026), building on reported ~70% confirmed response rate and progression-free survival (PFS) just north of six months in second-line small cell lung cancer.
- IDEAYA is advancing a pipeline of nine clinical stage molecules, with key focuses including MTAP deletion biology and the recently entered Phase 1 dual KAT6/7 inhibitor (ID574), which is a potential first-in-class agent.
- IDEAYA Biosciences, Inc. provided a business update on January 11, 2026, detailing key corporate objectives for 2026, including plans to advance four registrational trials.
- The company anticipates topline results from the registrational Phase 2/3 OptimUM-02 trial for darovasertib in metastatic uveal melanoma in Q1 2026, which, if positive, could enable a potential accelerated approval filing in the U.S..
- By H1 2026, darovasertib is expected to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma.
- IDEAYA targets initiating a monotherapy registrational study for IDE849 (DLL3 TOP1 ADC) in SCLC and/or NEC by the end of 2026, alongside initiating Phase 1 trials for IDE034, IDE892, and IDE574 in Q1 2026, and IDE161 in Q2 2026.
- The company reported approximately $1.1 billion in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund its operating plan into 2030.
- IDEAYA Biosciences reported approximately $1.1 billion in cash and equivalents, providing a financial runway into 2030.
- The company completed full enrollment in December 2025 for its pivotal Phase 2/3 trial of Darovasertib + Crizotinib in HLA*A2-Negative metastatic uveal melanoma, with topline randomized PFS results expected to enable a potential U.S. accelerated approval filing in 2026.
- Darovasertib + Crizotinib demonstrated a median Progression-Free Survival (PFS) of 7.0 months and a median Overall Survival (OS) of 21.1 months in metastatic uveal melanoma.
- The company's lead ADC product candidate, IDE849 (DLL3), showed compelling initial efficacy in SCLC with an Objective Response Rate (ORR) of 73.2% and a Disease Control Rate (DCR) of 93.0%, and is targeting registrational trial initiation in the 2L+ setting by year-end 2026.
- IDEAYA is advancing a pipeline of 9 clinical stage programs with several key milestones targeted for 2026, including a Phase 2 readout for IDE397 in urothelial cancer and initiation of a Phase 3 trial for Darovasertib in adjuvant uveal melanoma.
- IDEAYA Biosciences expects topline results, including progression-free survival (PFS) data, from the registrational Phase 2/3 OptimUM-02 trial of darovasertib in first-line metastatic uveal melanoma (mUM) in Q1 2026, which could enable a potential accelerated approval filing in the United States. Darovasertib is also anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 2026.
- The company plans to initiate a monotherapy registrational study for IDE849 (DLL3 TOP1 ADC) in second-line/refractory small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026. Additionally, an Investigational New Drug (IND) application for IDE574 (KAT6/7) was cleared in January 2026, with a Phase 1 dose escalation trial targeted for Q1 2026.
- IDEAYA Biosciences reported approximately $1.1 billion in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund its current operating plan into 2030.
- IDEAYA Biosciences (IDYA) has completed targeted full enrollment of 435 patients in its pivotal Phase 2/3 OptimUM-02 trial evaluating darovasertib in combination with crizotinib for first-line HLA*A2-negative metastatic uveal melanoma.
- The company anticipates reporting topline median Progression-Free Survival (PFS) data in the first quarter of 2026, which could support a potential accelerated approval filing in the United States.
- This milestone is significant for a potential full approval filing, addressing a clear unmet need in metastatic uveal melanoma, an aggressive form of ocular cancer with limited treatment options.
- Darovasertib has previously received U.S. FDA Breakthrough Therapy Designation as neoadjuvant therapy in primary uveal melanoma and Fast Track designation for the combination with crizotinib in metastatic UM.
- Darovasertib, IDEAYA Biosciences' lead program, is expecting randomized median progression-free survival (PFS) results for its first-line registrational study in metastatic uveal melanoma between year-end 2025 and Q1 2026, which could enable an accelerated approval filing in the U.S..
- The company reported robust activity for its DLL3 topo ADC, with a 70% confirmed response rate in second-line small cell lung cancer at a 2.4 mg/kg dose and a PFS of approximately 6.7 months across dose escalation. Further updates on phase one data and neuroendocrine tumors (NETs) are anticipated.
- For its MTAP deletion programs, IDEAYA plans a clinical data update for urothelial cancer (in combination with Gilead) in the first half of 2026, targeting a major medical conference, with an expected six months of follow-up and data from 20-30 patients.
- IDEAYA is developing a B7-H3, PTK7 bispecific ADC, designed to target cells with co-expression of both antigens, which are found in approximately one-third of non-small cell lung cancer patients and 40%-50% of colorectal cancer patients. More detailed disclosures are planned for the first half of 2026.
- IDEAYA Biosciences anticipates randomized median progression-free survival (PFS) results for its lead program, Darovasertib, in metastatic uveal melanoma by year-end or Q1 of next year, which could enable its first potential accelerated approval filing in the U.S.. Full enrollment for the median overall survival (OS) component is also nearing completion.
- The company plans to launch a phase 3 adjuvant randomized trial for Darovasertib with Pfizer in the first half of next year, following Breakthrough Therapy Designation for its neoadjuvant trial.
- IDEAYA's DLL3 topo ADC demonstrated a 70% confirmed response rate in second-line small cell lung cancer at a 2.4 mg/kg dose, with a median PFS of approximately 6.7 months. Updates on phase one data, including for neuroendocrine tumors (NETs), are expected.
- Clinical data updates for the MTAP deletion program IDE397 (MAT2A) are planned for the first half of next year in urothelial cancer (targeting ~6 months follow-up) and the second half for lung cancer (potentially 9-12 months follow-up).
- IDEAYA is developing a first-in-class B7-H3, PTK7 bispecific ADC, designed to target cells with dual positivity, with high co-expression noted in non-small cell lung cancer and colorectal cancer.
- IDEAYA Biosciences anticipates a randomized progression-free survival (PFS) readout for its lead program, Darovasertib, in metastatic uveal melanoma by year-end 2025 to Q1 2026, which could enable its first potential accelerated approval filing in the U.S.
- The company reported robust activity for its DLL3 topo ADC, showing a 70% confirmed response rate in second-line small cell lung cancer at a 2.4 mg/kg dose and a median PFS of approximately 6.7 months across dose escalation.
- IDEAYA plans a clinical data update in H1 2026 for its MAT2A inhibitor (IDE397) in urothelial cancer in combination with Gilead's TROP2, and a H2 2026 update for lung cancer.
- New programs include a PARG inhibitor (IDE161), expected to amplify the durability of topoisomerase payloads and be implemented with DLL3, and a first-in-class B7-H3, PTK7 bispecific ADC with an IND recently filed.
Quarterly earnings call transcripts for IDEAYA Biosciences.
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