UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 1 3, 2026

IDEAYA Biosciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-38915

47-4268251

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

5000 Shoreline Court, Suite 300

South San Francisco, California 94080

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 443-6209

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

IDYA

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 1, 2026, IDEAYA Biosciences, Inc. (the “Company”) presented an investor presentation in connection with the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01

Other Events.

~~IDEAYA~~Clinical ~~Biosciences~~Collaboration ~~and~~with ~~Servier~~Roche ~~Provide~~in ~~Complete Data from Phase 2/3 Registrational OptimUM~~MTAP-02Deleted ~~Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late~~RAS-~~Breaking~~Mutant ~~Oral~~Pancreatic ~~Presentation~~Cancer ~~at ASCO~~

On June 13, 2026, IDEAYA Biosciences, Inc. (the “Company”) ~~and~~announced ~~Les~~it ~~Laboratoires~~has ~~Servier~~entered into a clinical collaboration with F. Hoffmann-La Roche Ltd (“~~Servier~~Roche”) ~~presented~~to ~~complete~~evaluate ~~data from~~ the ~~primary~~efficacy ~~analysis~~and safety of ~~their~~IDE892, ~~registrational~~its ~~Phase~~investigational, ~~2/3~~potential ~~OptimUM~~best-02in-class ~~trial~~PRMT5 ofinhibitor, ~~darovasertib~~ in combination with ~~crizotinib~~Roche’s ~~(“darovasertib~~RG6505, ~~combination”)~~a inpan-RAS ~~first~~inhibitor, ~~line~~in ~~(“1L”)~~patients ~~HLA*A2:01~~with ~~negative~~pancreatic ~~metastatic~~ductal ~~uveal~~adenocarcinoma ~~melanoma~~ (“~~mUM~~PDAC”) atthat ~~ASCO.~~carry ~~The~~an ~~data~~MTAP ~~were~~deletion. ~~provided~~The inCompany awill ~~late-breaking~~sponsor ~~oral~~the ~~presentation~~clinical bytrial ~~Dr. Marlana~~combination ~~Orloff~~study, ~~M.D., Professor of Medical Oncology at Thomas Jefferson University Hospital~~ and ~~lead~~Roche ~~investigator~~will onsupply ~~the trial~~RG6505.

~~OptimUM-02~~IDE892 iswas adesigned ~~global,~~to ~~registrational~~be ~~Phase 2/3 trial evaluating~~ a ~~total~~potential ofbest-in-class ~~313~~PRMT5 ~~patients~~inhibitor ~~with~~and 1Lhas ~~HLA*A2:01~~demonstrated ~~negative~~robust ~~mUM,~~monotherapy ~~randomized~~regressions ~~2:1~~in ~~to the darovasertib combination or an investigator’s choice of therapy (“ICT”) arm reflective of real~~MTAP-~~world~~deleted ~~clinical~~preclinical ~~practice that included ipilimumab plus nivolumab or pembrolizumab~~models. The ~~primary~~Company ~~endpoint to support accelerated approval~~ is ~~median~~evaluating ~~progression-free~~IDE892 ~~survival~~in ~~(“PFS”)~~a asPhase ~~assessed~~1 bydose ~~blinded~~escalation ~~independent~~clinical ~~central~~trial ~~review~~in ~~(“BICR”).~~MTAP-deleted ~~Secondary~~solid ~~endpoints~~tumors ~~include safety~~ and ~~investigator~~plans ~~assessed~~to ~~PFS,~~initiate ~~overall~~Phase ~~response~~1 ~~rate~~combination ~~(“ORR”)~~cohorts, ~~disease~~in ~~control~~PDAC ~~rate~~with ~~(“DCR”)~~RG6505 ~~and~~as ~~duration~~well ~~of response. Data presented at ASCO were~~ as ofin aNSCLC ~~cutoff date of January 23, 2026~~ and ~~included~~other ~~additional~~solid ~~detail~~tumors onwith ~~baseline characteristics as well as safety~~IDE397, ~~secondary~~the ~~endpoints~~Company’s ~~and~~proprietary ~~median~~MAT2A ~~PFS across patient subgroups~~inhibitor.

~~Key~~MTAP ~~Findings~~deletion ~~from~~is ~~OptimUM~~estimated to occur in up to 40% of PDAC and almost all MTAP-02deleted PDAC harbor co-occurring RAS mutations. Combining a PRMT5 inhibitor with a pan-RAS inhibitor may have the potential to drive deeper and more durable responses for MTAP-deleted PDAC patients who currently have no approved targeted treatment options.

•Under ~~Primary~~the ~~endpoint~~clinical (collaboration, the Company and Roche each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be a joint governance process between the Company and Roche to oversee the clinical combination study. The clinical collaboration also has the ability to evaluate a combination triplet with IDE892, RG6505, and IDE397, the Company’s Phase 2 ~~portion):~~MAT2A ~~progression~~inhibitor, ~~free~~upon ~~survival~~joint byapproval ~~BICR~~from both the Company and Roche.

• The trial met the primary endpoint, with patients treated with 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).

• Patients treated with the darovasertib combination also had a statistically significant improvement in median PFS of 6.7 months versus 2.7 months for ICT by investigator assessment (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).

• Notably, the darovasertib combination reduced the risk of disease progression by 58% and 64% as assessed by BICR and investigator assessment, respectively.

• Treatment with the darovasertib combination demonstrated a consistent and meaningful improvement in median PFS relative to the ICT arm across a broad range of patient subgroups, including age and gender, type of immune therapy used in ICT, LDH stratification, ECOG status and site of metastasis.

• Secondary endpoints: ORR, DCR, duration of response

• Patients treated with the darovasertib combination had an ORR of 37.1% (78/210) and 39.5% (83/210) as assessed by BICR and investigator, respectively, compared to 5.8% (6/103) and 1.9% (2/103) in the ICT arm (p-value: <0.0001).

• The darovasertib combination led to a disease control rate of 73.3% (154/210) and 74.3% (156/210) by BICR and investigator assessment, respectively, compared to 31.1% (32/103) and 27.2% (28/103) in the ICT control arm.

• The median duration of response was 6.8 months (95% CI: 5.5, 11.3) by BICR and 6.8 months (95% CI: 4.8, 9.7) by investigator assessment based on a median follow-up time of 7.4 months as of the cutoff date.

• Overall survival (Primary endpoint of the Phase 3 portion)

• As noted in the topline results, data on overall survival (“OS”) was still immature as of the cutoff date, however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm.

• The Company will provide the next OS update as part of the pre-specified interim analysis. Overall survival data, when available, will be used to support a potential full approval in the United States and globally.

• Safety

• The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with previous results and known side-effects of each agent alone.

• Median relative dose intensities of darovasertib and crizotinib were 91.0% and 77.1%, respectively, compared to 100% for the ICT arm.

• Grade 3/4 treatment-related adverse events (“TRAEs”) occurred in 40.6% (97/239) of patients in the darovasertib combination arm compared to 37.0% (37/100) of patients in the ICT control arm.

• Treatment-related serious adverse events were 9.2% (22/239) and 25.0% (25/100) in the darovasertib combination and ICT arms, respectively.

• Low discontinuation rate due to TRAEs for darovasertib (2.5%) and crizotinib (10.0%) relative to ICT (19.0%).

• The most common Grade 3/4 TRAEs included diarrhea (10.0%), syncope (7.1%) and hypotension (3.8%) in the darovasertib combination arm compared to elevated liver enzymes (ALT, 7.0% / AST, 7.0%), diarrhea (6.0%), hepatitis (5.0%) and colitis (4.0%) in the ICT control arm.

In April 2026, the Company announced the U.S. Food and Drug Administration (“FDA”) has agreed to review its new drug application (“NDA”) for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-Time Oncology Review program. This program allows applicants to pre-submit components of their NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The Company completed its first pre-submission in May and expects to complete the NDA filing in the second half of 2026.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

ExhibitNo.		Description
99.1		ASCO Presentation, dated June 1, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

Forward-Looking Statements

Certain statements contained herein are forward-looking statements, ~~within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include~~including, but ~~are~~ not limited to, statements ~~regarding:~~related to (i) the potential therapeutic benefit, safety, ~~tolerability~~ and ~~clinical~~efficacy ~~activity~~ of ~~darovasertib~~IDE892, alone or in combination with ~~crizotinib~~RG6505; (ii) the ~~potential~~planned ~~significance~~clinical development, including the initiation, timing, progress, and ~~implications~~design of ~~data~~clinical ~~from~~trials ~~the~~evaluating ~~Phase~~IDE892 ~~2/3~~in ~~registrational~~combination ~~OptimUM-02~~with ~~trial~~RG6505 and other agents; (iii) ~~expectations~~the ~~regarding~~potential ~~overall~~for ~~survival~~IDE892 ~~analyses~~to ~~and~~be ~~timing~~a ofbest-in-class ~~interim~~PRMT5 ~~data updates~~inhibitor; (iv) the ~~Company’s~~potential ~~plans~~for ~~and~~combination ~~expectations~~therapies ~~regarding~~targeting ~~regulatory~~MTAP-deleted ~~submissions, including the timing~~ and ~~completion~~RAS-mutant oftumors ~~the~~to ~~NDA~~drive ~~submission~~deeper ~~under~~or ~~the~~more ~~FDA’s~~durable ~~Real-Time Oncology Review program~~responses; (v) the ~~potential~~estimated ~~for~~prevalence ~~accelerated approval and/or full approval~~ of ~~darovasertib~~MTAP deletions in ~~combination~~PDAC; ~~with~~(vi) the ~~crizotinib~~potential inbenefits of the ~~United~~clinical ~~States~~collaboration ~~and~~with ~~globally~~Roche; and (vivii) the Company’s ~~strategy,~~broader ~~business~~clinical ~~plans~~ and ~~objectives.~~strategic ~~Such~~plans, ~~forward-looking~~including ~~statements are based on~~ the ~~Company’s~~development ~~current~~of ~~expectations,~~its ~~estimates,~~MTAP-deletion ~~assumptions,~~portfolio. ~~and~~Such ~~beliefs~~forward-looking ~~regarding~~statements ~~future~~involve ~~events and are subject to~~ substantial risks and uncertainties that could cause ~~actual~~the Company’s preclinical and clinical development programs, future results, ~~outcomes~~performance or ~~events~~achievements to differ ~~materially~~significantly from those expressed or implied by ~~such~~the forward-looking statements. ~~These~~Such risks and uncertainties include, among others:, risks related to the ~~discovery~~success, ~~development~~cost, and ~~regulatory~~timing ~~approval~~ of ~~drug~~the ~~candidates;~~Company’s ~~risks~~product ~~related~~candidate todevelopment ~~the~~activities ~~timing, progress~~ and ~~results of~~ clinical trials,; ~~including~~the ~~uncertainties~~risk ~~regarding~~that ~~enrollment,~~results ~~safety,~~from ~~efficacy~~preclinical ~~and~~studies ~~durability~~or ofearly ~~response; risks that~~ clinical ~~trial~~trials ~~results~~ may not be ~~replicated~~predictive inof future ~~studies~~clinical ~~or support regulatory approval~~results; risks related to ~~regulatory interactions, submissions and decisions, including~~ the ~~timing~~development and ~~outcome~~regulatory approval of ~~NDA~~drug ~~review processes~~candidates; risks related to ~~manufacturing~~the ~~and~~Company’s ~~supply;~~dependence ~~risks~~on ~~related~~third toparties, ~~competition~~including ~~and~~Roche, ~~changes~~for incollaboration ~~the~~activities ~~standard~~and ofclinical ~~care~~supply; ~~the~~risks ~~timing~~related ~~and~~to ~~success of commercialization efforts;~~ the ~~outcome~~ability ofto ~~collaborations~~successfully ~~and~~enroll ~~licensing~~patients ~~arrangements;~~in ~~the~~clinical ~~Company’s dependence on third parties~~trials; and risks related to the ~~Company’s~~potential ~~ability~~for toadverse ~~obtain,~~safety ~~maintain,~~events ~~protect~~or ~~and~~lack ~~enforce~~of ~~intellectual property rights for its product candidates~~efficacy. All forward-looking statements are made as of the date hereof, and the Company undertakes no obligation to update any forward-looking statements to reflect new information, future events, or otherwise, except as required by law. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the Company’s Annual Report on Form 10-K dated February 17, 2026, the Company’s Quarterly Report on Form 10-Q dated May 5, 2026, and any subsequently filed current and periodic reports filed or furnished with the Securities and Exchange Commission.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

IDEAYA BIOSCIENCES, INC.

~~IDEAYA BIOSCIENCES, INC.~~

Date: June 1, 2026

/s/ Yujiro Hata

Date: June 3, 2026

/s/ Yujiro Hata

Yujiro Hata

Yujiro S. Hata

President and Chief Executive Officer

Filing Compare · IDEAYA Biosciences, Inc.