On November 4, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported a business update and announced financial results for the third quarter ended September 30, 2025.
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"This quarter we continued to make significant progress across the pipeline and broader business, including the partnership with Servier that extends our runway into 2030 and enables potential commercialization of darovasertib outside of the United States. We have also provided multiple major medical conference clinical data updates at WCLC, ESMO (Free ESMO Whitepaper) and SMR, and completed our third IND filing in 2025 to further extend our industry leadership in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
Selected Pipeline Developments and Upcoming Milestones
Darovasertib
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Metastatic uveal melanoma (mUM)
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Median progression-free survival (PFS) data from the Phase 2/3 trial (OptimUM-02) of darovasertib in combination with crizotinib in first line (1L) HLA*A2:01-negative mUM is on track to be reported by year-end 2025 to 1Q 2026; this data has the potential to enable an accelerated approval filing in the United States. The trial is nearing full enrollment, which remains on track to be completed by year-end.
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In October 2025, data from the single-arm, Phase 2 trial (OptimUM-01) of darovasertib in combination with crizotinib were presented at the Society for Melanoma Research (SMR) Congress in Amsterdam, Netherlands. Data were from a total of 44 1L mUM patients, including both HLA*A2:01-negative and HLA*A2:01-positive patient subsets. Highlights include:
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21.1 month median overall survival (OS) and 7.0 month median progression free survival (PFS) across all patients
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In 41 efficacy-evaluable patients, confirmed overall response rate (ORR) of 34% (14/41) with a 9.0 month median duration of response (mDOR)
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Disease control rate (DCR) of 90% (37/41), with 85% (35/41) of patients achieving ‘any reduction’ in target lesions
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The combination continued to be well-tolerated with the most common treatment-related adverse events (TRAEs >30%) of diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia, and fatigue
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Neoadjuvant therapy for primary uveal melanoma (UM)
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In October 2025, the company presented positive data from the randomized Phase 2 trial (OptimUM-09) in a Proffered Paper Oral Presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Berlin, Germany. Data were from a total of 95 patients, including 56 recommended for enucleation (EN) and 39 eligible for plaque brachytherapy (PB). Highlights include:
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Ocular tumor shrinkage in ~83% (78/94) of patients assessed, the majority of whom achieved ≥20% tumor shrinkage
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Among evaluable EN patients, the eye preservation rate was 57% (24/42), which increased to 95% (19/20) in patients achieving ≥20% tumor shrinkage
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In evaluable PB eligible patients, ~70% (26/37) achieved a reduction in predicted radiation dose to the eye from baseline, resulting in ~65% (24/37) having lower predicted risk of vision loss 3-years post-PB treatment
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During neoadjuvant treatment with darovasertib, ~55% (29/53) of EN and ~61% (23/38) of PB patients showed an improvement in baseline visual acuity scores (VAS), with a mean gain of 17 and 10 letters, respectively
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Darovasertib continued to be well-tolerated, with a low rate of serious adverse events and TRAEs leading to discontinuation
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IDEAYA has initiated a randomized Phase 3 registration-enabling trial of darovasertib as a single-agent in the neoadjuvant setting of primary UM. The trial, referred to as OptimUM-10, will enroll a total of approximately 450 patients in two cohorts of PB- and EN-recommended patients.
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Target enrollment was revised downward from our previous estimate of 520 patients due to a reduction of 70 patients in the PB cohort (prior guidance of 400, now 330 patients) based on additional FDA feedback on the statistical plan (alpha usage) across the two cohorts.
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Adjuvant therapy for primary UM
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In collaboration with Servier, IDEAYA plans to initiate a global Phase 3 combination trial of darovasertib and crizotinib as an adjuvant therapy for primary UM in the first half of 2026.
IDE397 (MAT2A)
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Positive data were reported from the ongoing Phase 1/2 trial of IDE397 in combination with Gilead’s Trodelvy (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with MTAP-deleted urothelial cancer (UC).
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57% ORR (4/7; 4cPR) at 30 mg IDE397 plus 7.5mg/kg Trodelvy (Dose level 2).
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Median PFS and mDOR were not yet reached.
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Manageable safety profile consistent with known adverse events of both drugs as single agents.
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IDEAYA has selected Dose level 2 as the go-forward dose for the IDE397 and Trodelvy clinical combination in MTAP-deleted UC and has achieved first-patient-in (FPI) in NSCLC. The next clinical update from the combination trial is planned for a medical conference in the first half of 2026.
IDE849 (DLL3 TOP1i ADC)
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IDEAYA’s partner, Hengrui Pharma, presented clinical safety and efficacy data from over 70 small-cell lung cancer (SCLC) patients from their Phase 1 clinical trial at the 2025 International Association for the Study of Lung Cancer ("IASLC") World Conference on Lung Cancer (WCLC) in Barcelona, Spain. Data included 87 patients with small-cell lung cancer (SCLC) and 13 patients with other neuroendocrine carcinomas (NEC) as of a cut-off date of June 20, 2025. A total of 71 refractory (2L+) SCLC patients were evaluated for efficacy at doses of IDE849 between 2.4mg/kg and 4.2 mg/kg. Highlights include:
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At the 2.4 mg/kg expansion dose of IDE849, 2L patients demonstrated an 80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR; across all lines of therapy (2L+) at this dose the ORR and confirmed ORR decreased modestly to 73.7% (14/19) and 57.9% (11/19) (1 pending confirmation), respectively.
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Across all doses of IDE849 tested, 2L patients showed a 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) whereas a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) was observed across all lines of therapy at all doses (≥2.4 mg/kg).
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Patients with baseline brain metastases had an 83.3% (5/6) confirmed ORR at the 2.4 mg/kg dose and a 66.7% (12/18) confirmed ORR (1 pending confirmation) across all doses (≥2.4 mg/kg).
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6.7 month median PFS achieved across all lines and all doses (≥2.4 mg/kg); the median PFS was not reached in 2L patients.
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In May 2025, IDEAYA initiated a global Phase 1 trial of IDE849 and has achieved FPI in the United States. The company continues to enroll SCLC patients with plans to expand into patients with neuroendocrine tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025.
Other programs
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IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025.
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IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing.
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IDE705 (GSK101), a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 dose escalation in combination with niraparib, GSK’s small molecule inhibitor of PARP, is ongoing in patients with solid tumors.
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Phase 2 dose expansion in BRCA-mutant solid tumors would trigger a $10 million milestone payment from GSK.
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IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, is being developed for patients with MTAP-deleted lung cancer and other high priority MTAP-deleted solid tumor indications. IDEAYA received IND clearance from the FDA in the third quarter and expects to begin a Phase 1 dose escalation trial by the end of the year with the goal of advancing into combination trials with IDE397 in the first half of 2026.
In the fourth quarter IDEAYA submitted an IND for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, and is on track to file an IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor, by the end of the year.
License agreement with Servier
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IDEAYA entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States. The company received an upfront payment of $210 million, and is eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs. IDEAYA retains all rights to darovasertib in the United States.
Financial Results for the Quarter Ended September 30, 2025
As of September 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.14 billion, compared to $991.9 million as of June 30, 2025. The increase was primarily driven by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib, offset by the net cash used in operations.
Collaboration revenue for the three months ended September 30, 2025, totaled $207.8 million compared to zero for the three months ended June 30, 2025. Collaboration revenue was recognized for the performance obligations satisfied through September 30, 2025 related to the development and commercialization license recognized upon execution and the research and development services that will be recognized over time under the Servier exclusive license agreement for darovasertib. As of September 30, 2025, the remaining balance for the research and development services performance obligations is $143.1 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.
Research and development (R&D) expenses for the three months ended September 30, 2025 totaled $83.0 million compared to $74.2 million for the three months ended June 30, 2025. The increase was primarily driven by higher clinical trial and CMC manufacturing expenses to support our programs.
General and administrative (G&A) expenses for the three months ended September 30, 2025 totaled $16.4 million compared to $14.6 million for the three months ended June 30, 2025. The increase was primarily due to higher legal expenses to support company growth and commercial expenses to support the darovasertib commercial preparation activities.
The net income for the three months ended September 30, 2025, was $119.2 million compared to the net loss of $77.5 million for the three months ended June 30, 2025. Total stock compensation expense for the three months ended September 30, 2025, was $12.2 million compared to $11.9 million for the three months ended June 30, 2025.
(Press release, Ideaya Biosciences, NOV 4, 2025, View Source [SID1234659358])