IDEAYA Biosciences (NASDAQ: IDYA) teams with AstraZeneca on IDE849-Imfinzi SCLC trial

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8-K Event Classification

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What clinical collaboration did IDEAYA Biosciences (IDYA) announce with AstraZeneca?

What is IDE849 in the IDEAYA Biosciences (IDYA) and AstraZeneca study?

Which cancers are targeted in IDEAYA Biosciences’ IDE849 Phase 1 trial?

Who sponsors and supplies drugs in the IDEAYA (IDYA) and AstraZeneca collaboration?

Where will IDEAYA Biosciences’ IDE849 clinical trial enroll patients?

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

IDEAYA Biosciences entered a clinical collaboration with AstraZeneca to test IDEAYA’s investigational DLL3 TOP1 antibody-drug conjugate IDE849 together with AstraZeneca’s PD-L1 inhibitor Imfinzi in extensive-stage small cell lung cancer.

IDEAYA will sponsor the combination study, while AstraZeneca supplies Imfinzi. IDEAYA is running a multi-site global Phase 1 clinical trial of IDE849 in DLL3 upregulated solid tumors, including small cell lung cancer, neuroendocrine carcinomas, neuroendocrine tumors, and melanoma, reflecting significant unmet medical need and the potential of DLL3 as a targeted therapy approach.

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

clinical collaboration agreement, antibody-drug conjugate, Phase 1 clinical trial, programmed death-ligand 1 (PD-L1) inhibitor, +2 more

6 terms

clinical collaboration agreement financial

"entered into a clinical collaboration agreement with AstraZeneca plc"

antibody-drug conjugate medical

"IDE849, the Company’s investigational, potential first-in-class DLL3 TOP1 antibody-drug conjugate"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

Phase 1 clinical trial medical

"advancing a multi-site global Phase 1 clinical trial for IDE849"

A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.

programmed death-ligand 1 (PD-L1) inhibitor medical

"Imfinzi® (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor"

extensive-stage small cell lung cancer medical

"in extensive-stage small cell lung cancer (“SCLC”)"

Extensive-stage small cell lung cancer is a fast-growing form of lung cancer that has spread beyond the original lung area to other parts of the chest or body. Because it is widespread at diagnosis, it usually requires systemic treatments like chemotherapy or immunotherapy rather than localized fixes, and has a more guarded outlook; for investors, that affects how big the market is for new drugs, trial designs, approval chances, and potential treatment costs.

neuroendocrine tumors medical

"including SCLC, neuroendocrine carcinomas (“NECs”), neuroendocrine tumors (“NETs”), and melanoma"

Neuroendocrine tumors are a type of abnormal growth that originates from cells responsible for releasing hormones into the bloodstream. These tumors can develop in various parts of the body and sometimes grow slowly or remain hidden for years. Their potential to affect hormone levels and spread makes them important for investors to monitor, especially as advancements in treatment may influence healthcare company performance.

Understanding 8-K Material Events →

04/09/2026 - 06:01 AM

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): April 8, 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 8.01

Other Events.

On April 8, 2026, IDEAYA Biosciences, Inc. (the “Company”) entered into a clinical collaboration agreement with AstraZeneca plc (“AstraZeneca”) to evaluate the efficacy and safety of IDE849, the Company’s investigational, potential first-in-class DLL3 TOP1 antibody-drug conjugate, in combination with AstraZeneca’s Imfinzi^®(durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, in extensive-stage small cell lung cancer (“SCLC”). The Company will sponsor the clinical combination study and AstraZeneca will supply Imfinzi^®.

The Company is advancing a multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, neuroendocrine carcinomas (“NECs”), neuroendocrine tumors (“NETs”), and melanoma. The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia.

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NECs, NETs, non-small cell lung cancer, and melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s beliefs, plans, and expectations, are forward-looking statements. Such statements may be identified by words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “may,” “plans,” “potential,” “will,” and similar expressions or their negatives. Forward-looking statements in this report include, but are not limited to, statements related to (i) the plans for the clinical collaboration agreement with AstraZeneca; (ii) the potential therapeutic benefits of the Company’s therapeutics; and (iii) the timing and content of clinical program updates. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by such statements, including, among others: the uncertainties inherent in early-stage clinical development; the risk that preclinical or clinical trial results may not be predictive of future results; the risk that clinical trials may not enroll, or proceed as planned; the risk that the Company’s product candidates may not demonstrate sufficient safety or efficacy; risks related to regulatory submissions, approvals, and commercialization; and risks related to the Company’s reliance on third-party collaborators. Investors are cautioned not to place undue reliance on these forward-looking statements. 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 and any current and periodic reports filed or furnished with the Securities and Exchange Commission. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by applicable securities laws.

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.

Source: View Original Filing on SEC EDGAR

IDEAYA Biosciences entered a clinical collaboration agreement with AstraZeneca to study IDE849 with AstraZeneca’s Imfinzi in extensive-stage small cell lung cancer. IDEAYA will sponsor the combination trial, while AstraZeneca will supply Imfinzi, aiming to evaluate safety and efficacy in this difficult-to-treat cancer.

IDE849 is IDEAYA Biosciences’ investigational, potential first-in-class DLL3 TOP1 antibody-drug conjugate. It targets DLL3, which is reported to be upregulated in several solid tumor types, and is being evaluated for safety and efficacy in a global Phase 1 clinical trial program.

The IDE849 Phase 1 trial focuses on DLL3 upregulated solid tumors, including extensive-stage small cell lung cancer, neuroendocrine carcinomas, neuroendocrine tumors, and melanoma. These cancers have significant unmet medical need, and DLL3’s limited expression in normal tissues makes it a promising therapeutic target.

IDEAYA Biosciences will sponsor the clinical combination study evaluating IDE849 with AstraZeneca’s Imfinzi. AstraZeneca will supply Imfinzi, a PD-L1 inhibitor, for the trial. This structure lets IDEAYA lead study operations while leveraging AstraZeneca’s established immunotherapy agent.

IDEAYA’s multi-site global Phase 1 clinical trial for IDE849 plans to enroll patients across North America, Europe, Australia, South America, and Asia. This broad geographic footprint is designed to access diverse patient populations with DLL3 upregulated solid tumors, including small cell lung cancer.

IDEAYA BIOSCIENCES, INC.

Date: April 9, 2026

/s/ Yujiro Hata

Yujiro Hata

President and Chief Executive Officer

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