IDEAYA Biosciences (IDYA) Company Report

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.

1 day ago

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IDEAYA Biosciences Provides Updates on Darovasertib, DLL3 ADC, and MTAP Programs

IDYA

Product Launch

New Projects/Investments

Guidance Update

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.

1 day ago

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IDEAYA Biosciences Provides Pipeline Updates and Upcoming Milestones

IDYA

New Projects/Investments

Guidance Update

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.

1 day ago

Transcript

IDEAYA Biosciences Details Clinical Pipeline Progress and Upcoming Milestones

IDYA

New Projects/Investments

Guidance Update

Darovasertib, IDEAYA's lead program for uveal melanoma, anticipates top-line results for its first-line metastatic uveal melanoma (MUM) registrational trial between year-end 2025 and Q1 2026 for potential accelerated approval. The company is also advancing darovasertib in neoadjuvant and adjuvant uveal melanoma with two additional Phase III registrational trials, having received Breakthrough Therapy Designation for the neoadjuvant setting.
IDEAYA is developing a diversified MTAP deletion pipeline, including clinical-stage assets IDE397 (MAT2A inhibitor) and IDE892 (PRMT5 inhibitor), and a new program targeting CDKN2A co-alteration that is nearing development candidate nomination with an IND goal by end of 2026.
The DLL3 (IDE849 Topo ADC) program, focused on small cell lung cancer, has shown compelling response rates and durability, with a differentiated linker system. IDEAYA is planning for a potential monotherapy accelerated approval study and a frontline small cell lung cancer study, and is exploring combination with its proprietary IDE161 PARG inhibitor.
The company also highlighted a first-in-class clinical-stage bispecific ADC targeting B7H3 and PTK7 for dual-expression populations in cancers like non-small cell and colorectal cancer, which also has potential for combination with the PARG inhibitor (IDE161).

3 days ago

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IDEAYA Biosciences Provides Updates on Oncology Pipeline and Upcoming Catalysts

IDYA

New Projects/Investments

Guidance Update

Revenue Acceleration/Inflection

IDEAYA Biosciences' lead program, darovasertib, is nearing a significant catalyst with top-line results from its first-line registrational trial in metastatic uveal melanoma (MUM) expected from year-end 2025 to Q1 2026.
The company is expanding darovasertib's potential market with two additional registrational trials for neoadjuvant and adjuvant uveal melanoma, including a Breakthrough Therapy Designation for the neoadjuvant setting and an adjuvant study initiating in the first half of 2026 that could be a blockbuster opportunity.
IDEAYA is advancing a broad oncology pipeline, including three programs in the MTAP deletion space (MAT2A, PRMT5, and a new CDKN2A co-alteration program targeting an IND by end of 2026) , and the DLL3 ADC (IDE849) with registrational trial guidance expected early 2026.
The company also announced a first-in-class bispecific ADC targeting B7-H3 and PTK7, and is progressing other programs like a KAT6/7 inhibitor, Werner Helicase, and Pol Theta.

3 days ago

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IDEAYA Biosciences Provides Updates on Extensive Clinical Pipeline and Upcoming Milestones

IDYA

New Projects/Investments

Guidance Update

IDEAYA Biosciences expects top-line results for its lead program, Darovasertib, in the first-line registrational trial for metastatic uveal melanoma (MUM) between year-end 2025 and Q1 2026. Phase 2 data showed a median PFS of about seven months and response rates north of 30%, significantly exceeding historical benchmarks. The overall uveal melanoma market, including neoadjuvant and adjuvant settings, is projected to be a billion-dollar opportunity.
The company is advancing multiple programs in the MTAP deletion space, which affects approximately 10% of all solid tumors. This includes a Phase 2 MAT2A inhibitor (IDE397), a Phase 1 PRMT5 inhibitor (IDE892), and a new program targeting CDKN2A co-alteration with an IND goal by the end of next year.
IDEAYA's DLL3 topo ADC (IDE849) for small cell lung cancer has shown compelling response rates and durability, with guidance on registrational trials for monotherapy accelerated approval and frontline small cell lung cancer expected early next year.
IDEAYA announced a first-in-class bispecific ADC targeting B7-H3 and PTK7, designed for enhanced efficacy in dual expression populations like non-small cell and colorectal cancer. The company also provided updates on its KAT6/7 inhibitor, Werner Helicase Program (with data expected sometime next year), and Pol Theta Program.

3 days ago

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IDEAYA Biosciences Provides Update on Darovasertib PFS Readout, DLL3 ADC, and Pipeline Progress

IDYA

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

IDEAYA Biosciences expects a randomized median PFS readout for its lead program, Darovasertib, in frontline metastatic uveal melanoma by year-end 2025 to Q1 2026, requiring approximately 130 PFS events for top-line results. The company anticipates a treatment arm PFS of seven to eight months.
The DLL3 topo ADC program, identified as a potential next registrational study, is showing monotherapy activity in small cell lung cancer and neuroendocrine tumors, with DLL3 PARG ID161 combo dosing targeted by the end of 2025. Safety data at the 2.4 mg/kg expansion dose showed grade three or higher AEs (largely blood-related) at less than 20%.
IDEAYA plans to file an IND by year-end 2025 for a first-in-class dual inhibitor of CAT6 and CAT7.
Enrollment for the neoadjuvant Darovasertib study is projected to complete in approximately five quarters, and the adjuvant program is slated to begin in H1 2026 with Servier, targeting 400-450 patients.

Nov 18, 2025, 1:00 PM

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IDEAYA Biosciences Provides Updates on Darovasertib Registrational Trial and Deep Pipeline Progress

IDYA

New Projects/Investments

Guidance Update

IDEAYA Biosciences anticipates a randomized median PFS readout for its lead program, Darovasertib, in frontline metastatic uveal melanoma between year-end 2025 and Q1 2026, targeting potential accelerated approval in the US. The company expects the treatment arm to show a PFS in the 7-8 month range.
The company is advancing a deep pipeline with eight clinical stage programs, targeting nine by year-end, including key assets in MTAP deletion and the ADC arena.
For its DLL3 topo ADC program, IDEAYA is exploring a monotherapy accelerated approval pathway and targets dosing for the DLL3 PARG ID161 combo by year-end 2025.
The MAT2A inhibitor (ID397) program is expected to provide Trodalvy combo data in urothelial carcinoma at a medical conference in H1 2026.
Enrollment for the Darovasertib neoadjuvant study is targeted for completion in approximately five quarters, and the adjuvant program is planned to start in H1 2026 with Servier.

Nov 18, 2025, 1:00 PM

Transcript

IDEAYA Biosciences Provides Update on Darovasertib Registrational Trial and Pipeline Progress

IDYA

Guidance Update

New Projects/Investments

Product Launch

IDEAYA Biosciences expects a randomized median PFS readout for its lead program, darovasertib, in frontline metastatic uveal melanoma, targeting an accelerated approval filing between year-end 2025 and Q1 2026. The company needs approximately 130 PFS events for top-line results, which are tracking on track.
The company's pipeline includes eight clinical stage programs, with plans for nine by year-end , featuring MTAP deletion assets (ID397 and ID892) and three ADC programs.
For the DLL3 topo ADC, IDEAYA is pursuing a monotherapy accelerated approval study path and plans to initiate DLL3 PARG ID161 combo dosing by the end of 2025.
Enrollment for the darovasertib neoadjuvant pivotal study is projected to complete in approximately five quarters, aided by a reduced patient number (from 400 to 330) and a five-fold increase in study sites.
IDEAYA plans to file an IND for its first-in-class CAT6/CAT7 dual inhibitor (CAT67) by year-end 2025, expanding its clinical-stage portfolio.

Nov 18, 2025, 1:00 PM

Transcript

IDEAYA Discusses Clinical Pipeline Progress and Strategic Milestones

IDYA

New Projects/Investments

Guidance Update

Product Launch

IDEAYA's lead program, darovasertib, is nearing a potential U.S. accelerated approval filing for metastatic uveal melanoma by Q1, with a Phase 3 adjuvant study planned for H1 next year. The neoadjuvant program received Breakthrough Therapy Designation.
The DLL3 program demonstrated a 70% confirmed response rate and 6.7-month progression-free survival (PFS) in second-line small cell neuroendocrine tumors, with a low rate of severe adverse events, supporting potential monotherapy accelerated approval.
The MTAP program, combining ID 397 with Trodelvy, achieved a 57% confirmed response rate in urothelial cancer and is expanding into lung cancer, targeting response rates of 40% or above for future registrational studies.
IDEAYA's PRMT5 asset has entered Phase 1, with plans to quickly combine it with ID 397 for frontline lung cancer, aiming for an efficacious dose by the second cohort.
The company is integrating machine learning and AI into its discovery programs, leading to approximately a 30% acceleration in time to IND.

Nov 6, 2025, 5:00 PM

Transcript

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