as of 11-06-2026 3:37pm EST
IDEAYA Biosciences Inc is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. Its approach integrates small molecule drug discovery with extensive capabilities in identifying and validating translational biomarkers to develop targeted therapies for select patient populations that are likely to benefit from these targeted therapies. The company's clinical-stage product candidates include darovasertib (PKC), IDE397 (MAT2A), IDE849 (DLL3), IDE275 (Werner Helicase), IDE161 (PARG), and IDE705 (Pol Theta Helicase). In addition, it also working on other development candidates and has multiple earlier-stage preclinical programs.
| Founded: | 2015 | Country: | United States |
| Employees: | N/A | City: | SOUTH SAN FRANCISCO |
| Market Cap: | 3.6B | IPO Year: | 2019 |
| Target Price: | $51.54 | AVG Volume (30 days): | 986.4K |
| Analyst Decision: | Strong Buy | Number of Analysts: | 16 |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -3.56 | EPS Growth: | 61.90 |
| 52 Week Low/High: | $26.81 - $42.68 | Next Earning Date: | 11-03-2026 |
| Revenue: | $218,710,000 | Revenue Growth: | 3024.43% |
| Revenue Growth (this year): | -80.14% | Revenue Growth (next year): | 216.42% |
| P/E Ratio: | -9.09 | Index: | |
| Free Cash Flow: | -73466000.0 | FCF Growth: | N/A |
President and CEO
Avg Cost/Share
$37.82
Shares
26,338
Total Value
$985,396.73
Owned After
691,495
| Insider | Ticker | Relationship | Date | Transaction | Avg Cost | Shares | Total Value | Owned After | SEC Forms |
|---|---|---|---|---|---|---|---|---|---|
| Hata Yujiro S | IDYA | President and CEO | Oct 6, 2026 | Sell | $37.82 | 26,338 | $985,396.73 | 691,495 |
SEC 8-K filings with transcript text
Nov 3, 2026 · 100% conf.
1D
+0.52%
$31.98
5D
+5.87%
$33.69
20D
+5.83%
$33.68
2 idya-ex99_1.htm
Exhibit 99.1
IDEAYA Biosciences Reports Financial Results for the Third Quarter 2026 and Provides a Business Update
• Data presented at ESMO 2026 collectively supports the potential of darovasertib to become a foundational new therapy across the treatment journey of uveal melanoma in both primary and metastatic disease, irrespective of HLA-A*02:01 allele status or line of therapy
• Completed NDA submission in Q3’26 to support the potential U.S. approval of darovasertib plus crizotinib in metastatic uveal melanoma
• Updated data from Hengrui-sponsored Phase 1 trial of IDE849 (DLL3 TOP1 ADC) presented at ESMO 2026 demonstrates robust anti-tumor activity and encouraging survival benefit in relapsed small cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC); initial data from IDEAYA-sponsored global Phase 1/2 trial expected by the end of 2026 / early 2027
• IDEAYA R&D Day scheduled for November 16th to highlight preclinical data supporting rational combinations that exploit MTAP/CDKN2A deficiency in KRAS-mutant cancers
• $1.15 billion in cash, cash equivalents and marketable securities as of September 30, 2026; cash runway guidance into 2030 remains unchanged based on current operating plan
SOUTH SAN FRANCISCO, Calif., Nov. 3, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery, development and commercialization of targeted therapeutics, today reported financial results for the third quarter ended September 30, 2026, and provided a business update.
“We are encouraged by the continued momentum at IDEAYA during the third quarter, marked by the successful completion of our first NDA filing for darovasertib in metastatic uveal melanoma,” said Yujiro S. Hata, Chief Executive Officer of IDEAYA. “We also provided multiple clinical data updates at ESMO on darovasertib to support its potential as a foundational therapy across the entire uveal melanoma treatment journey as well as updated data from IDE849, our DLL3 TOP1 ADC, in relapsed SCLC and NEC. Looking ahead, we are excited to share new preclinical data on our extensive MTAP/CDKN2A franchise in RAS-mutant cancers that provides the scientific rationale in support of the two clinical collaborations we established with Roche and Genentech.”
Selected Pipeline Developments and Corporate Updates
Darovasertib for Uveal Melanoma (UM)
• IDEAYA presented clinical data from two ongoing clinical trials in metastatic UM (mUM) at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The OptimUM-01 update focused on the Phase 2 expansion results in 101 HLA-A*02:01-positive patients, including both treatment naïve and 2L patients who received prior tebentafusp. The OptimUM-02 update builds on positive topline
Exhibit 99.1
data reported in June showing treatment naïve HLA-A*02:01-negative patients receiving darovasertib plus crizotinib (the darovasertib combination) had a meaningful and statistically significant improvement in median progression free survival (PFS) compared to investigator’s choice of therapy as determined by both blinded independent central review (BICR) and investigator assessment. Collectively, the data support the broad potential of the darovasertib combination to drive meaningful clinical benefits for patients with mUM, irrespective of HLA-A*02:01 allele status or line of therapy.
• During the third quarter IDEAYA successfully submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to support a potential U.S. approval of the darovasertib combination in mUM under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program.
• In primary UM, IDEAYA provided follow-up data at ESMO 2026 from approximately 119 patients enrolled in the Phase 2 OptimUM-09 trial evaluating single-agent darovasertib as a neoadjuvant therapy. Consistent with prior results, >85% of patients treated with darovasertib experienced robust tumor shrinkage, resulting in a 57% eye preservation rate in the enucleation cohort and 74-79% of patients in the plaque brachytherapy cohort achieving a reduced predicted dose of radiation to critical eye structures including the fovea, disc center and lens.
• Due to ongoing site activation and enrollment challenges, IDEAYA has decided to stop enrollment and close the Phase 3 OptimUM-010 trial. This is expected to result in estimated cost savings of $100-125 million that the company will reallocate towards other high-value programs in its pipeline, including potential registrational trials for IDE849 and IDE892.
o IDEAYA is committed to enabling patient access to neoadjuvant darovasertib and plans to submit published data from OptimUM-09 to support potential inclusion in clinical practice guidelines. If successful, guideline inclusion is intended to provide evidence to support the potential clinical benefit of neoadjuvant darovasertib and may all
Aug 4, 2026 · 18% conf.
1D
+0.35%
$36.23
Act: -0.19%
5D
+3.68%
$37.44
20D
+3.15%
$37.25
2 idya-ex99_1.htm
Exhibit 99.1
IDEAYA Biosciences Reports Second Quarter 2026 Financial Results and Provides Business Update
• Registrational OptimUM-02 trial of the darovasertib combination in metastatic uveal melanoma (mUM) met its primary endpoint; new drug application (NDA) filing is underway under the real-time oncology review program (RTOR) with completion expected in H2 2026
• Updated data from Phase 2 OptimUM-01 trial (HLA*A2-positive mUM patient subset) and Phase 2 OptimUM-09 trial (neoadjuvant primary UM) to be presented at ESMO
• Updated data from Hengrui-sponsored Phase 1 trial of IDE849 (DLL3 TOP1 ADC) in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) patients to be presented at ESMO
• Announced clinical collaboration with Roche to evaluate IDE892 (PRMT5) in combination with RG6505 (pan-RAS) in MTAP-deleted, RAS-mutant pancreatic cancer; targeting to initiate a Phase 1 combination trial in H2 2026
• IDEAYA to host an R&D Day in Q4 focused on MTAP/CDKN2A, KRAS, and pancreatic cancer
• ~$1.24 billion of cash, cash equivalents, and marketable securities as of June 30, 2026; cash runway guidance into 2030 is unchanged based on current operating plan
SOUTH SAN FRANCISCO, Calif., Aug. 4, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery, development and commercialization of targeted therapeutics, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.
"This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer. We presented the positive topline results at ASCO from our registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic uveal melanoma while continuing to advance our NDA submission and pre-commercial activities to support a possible commercial launch. Additionally, our clinical pipeline is poised to deliver several key updates throughout the remainder of 2026, including updated data from IDE849, our DLL3 TOP1 ADC, in SCLC and NEC and clinical progress in MTAP-deleted cancers with IDE892, our PRMT5 inhibitor, as both a monotherapy and in combination with IDE397, our proprietary MAT2A inhibitor, and RG6505, Roche’s Phase 1 pan-RAS inhibitor in NSCLC and PDAC, respectively. With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates,” said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.
Selected Pipeline Developments and Corporate Updates
Exhibit 99.1
Darovasertib for Uveal Melanoma
• IDEAYA presented complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois. Data were from a total of 313 patients with first line (1L) HLA*A2:01-negative mUM as of a January 23, 2026 cutoff date, randomized 2:1 to darovasertib in combination with crizotinib (the darovasertib combination) or an investigator’s choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1). The primary endpoint is median progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response.
o The trial met its primary endpoint, with patients receiving the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001). A similar result was observed based on investigator assessment, with the combination leading to a median PFS of 6.7 months versus 2.7 months in the ICT arm (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).
o Patients receiving the darovasertib combination also had clinically meaningful and statistically significant improvements across all key secondary endpoints.
o Overall survival (OS) data was still immature as of the January 23, 2026 cutoff date; however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027.
o Overall, the darovasertib combination was generally well-tolerated with a manageable safety profile, consistent with previous results and known side-effects of each agent.
• IDEAYA has completed enrollment of approximately 100 HLA*A2:01-positive mUM patients in the single-arm, Phase 2 OptimUM-01 trial of the darovasertib combination. The company plans to present updated ORR, PFS and OS result
May 5, 2026 · 100% conf.
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-2.93%
$27.96
Act: -0.21%
5D
-4.28%
$27.57
Act: -2.36%
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+2.85%
$29.62
Act: -1.39%
2 idya-ex99_1.htm
Exhibit 99.1
IDEAYA Biosciences Reports First Quarter 2026 Financial Results and Provides Business Update
• Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint; complete data will be provided in a late-breaking oral presentation at ASCO
• IDEAYA to initiate RTOR submission process with first pre-submission in May; targeting completion of the NDA filing in H2 2026
• Clinical updates from Phase 2 OptimUM-01 trial in HLA*A2-positive mUM, Phase 2 OptimUM-09 in neoadjuvant primary UM and Phase 1/2 trials with IDE849 (DLL3 TOP1 ADC) and IDE034 (B7H3/PTK7 bispecific TOP1 ADC) planned for H2 2026
• Initiation of registrational trial for IDE849 monotherapy in DLL3-positive solid tumors planned by year-end 2026; Phase 1 combination cohort of IDE892 (PRMT5) + IDE397 (MAT2A) in MTAP-deleted cancers to begin in mid-2026
• ~$973 million of cash, cash equivalents, and marketable securities as of March 31, 2026; current cash runway guidance into 2030 remains unchanged
SOUTH SAN FRANCISCO, Calif., May 5, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the first quarter ended March 31, 2026.
"This was a transformational quarter for IDEAYA, with positive topline results from the OptimUM-02 registrational trial in first line HLA*A2-negative metastatic uveal melanoma to enable the company’s first NDA submission for potential U.S. accelerated approval. We look forward to a catalyst rich second half of 2026, including targeted clinical data updates for the darovasertib combination in HLA*A2-positive mUM, IDE849 in DLL3-positive solid tumors, and IDE034, our potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, in multiple large solid tumor indications. Finally, clinical dose escalation is advancing rapidly for our potential first-in-class KAT6/7 dual inhibitor, IDE574, and our PRMT5 inhibitor, IDE892, with the goal of initiating clinical expansion and combination trials with IDE892 in MTAP-deleted PDAC and NSCLC in the second half of this year,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
Selected Pipeline Developments and Corporate Updates
Darovasertib in Uveal Melanoma
• On April 13th IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).
o The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and
achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR).
o On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months.
o Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm.
o The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.
• IDEAYA will provide complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois, and plans to submit a manuscript for publication in the second half of 2026. A new drug application (NDA) submission to the U.S. Food and Drug Association (FDA) is planned in the second half of 2026 to support a potential U.S. accelerated approval.
o The FDA has agreed to review IDEAYA’s NDA under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program, which allows an applicant to pre-submit components of its NDA for review before the complete filing is submitted to provide a more efficient review process and ensure safe and effective treatments are available to patients as early as possible.
• IDEAYA has completed enrollment of approximately 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib. The company plans to present data at a major medical conference from over 85 efficacy-evaluable HLA*A2-positive mUM patients in the second half of 2026.
o Data will include updated ORR, PFS, and OS results, which will be used to support a potential regulatory submission to the FDA to expand the labeled use of darovasertib and/or guideline inclusion to enable the use of the darovasertib combination in HLA*A2-positive mUM pat
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