IDEAYA Biosciences Announces IND Submission for IDE574, a Potential First-In-Class KAT6/7 Dual Inhibitor for Breast and Lung Cancers

Rhea-AI Summary

IDEAYA Biosciences (Nasdaq: IDYA) submitted an IND for IDE574 to the FDA on Dec 10, 2025. IDE574 is described as a potential first-in-class, equipotent, highly selective KAT6/7 dual inhibitor with reduced activity versus related KAT5/8 enzymes.

The company is targeting a Phase 1 monotherapy dose-escalation trial to begin in Q1 2026 and plans to present preclinical pharmacology and anti-tumor xenograft data for breast and lung cancer at a medical conference in 1H 2026.

Positive

• IND submission to FDA for IDE574 on Dec 10, 2025
• Phase 1 monotherapy dose-escalation targeted to start in Q1 2026
• Preclinical xenograft models show robust anti-tumor activity in lung and breast

Negative

• No clinical safety or efficacy data yet; human data pending Phase 1

Key Figures

Phase 1 start target 1Q 2026 Planned start of IDE574 monotherapy dose escalation trial

Preclinical data timing 1H 2026 Targeted presentation of IDE574 preclinical data at a medical conference

Market Reality Check

$34.08 Last Close

Volume Volume 1,028,662 is at 1.08x the 20-day average of 949,134, indicating only modestly elevated trading activity before this news. normal

Technical Shares at $34.08 are trading above the 200-day MA $23.65 and sit 8.09% below the 52-week high of $37.08.

Peers on Argus

IDYA was down 3.57% while close biotech peers showed mixed, mostly modest moves (e.g., DNLI +0.2%, GLPG +0.64%, FOLD -0.41%, TVTX +0.73%), pointing to a stock-specific move rather than a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	IND clearance IDE034	Positive	+4.7%	FDA IND clearance for IDE034 enabling Phase 1 solid tumor trial.
Dec 01	IND clearance IDE034	Positive	-3.7%	Announcement of FDA IND clearance and trial plans for IDE034 ADC.
Nov 28	Inducement stock options	Neutral	-0.7%	Nasdaq Rule 5635(c)(4) inducement option grant to a new employee.
Nov 24	Investor conferences	Neutral	+2.0%	Announcement of CEO fireside chats at two December healthcare conferences.
Nov 04	Q3 2025 earnings	Positive	-2.8%	Strong cash position, collaboration revenue and business update for Q3 2025.

Pattern Detected

Recent positive R&D and financial updates sometimes saw mixed or negative next-day stock reactions, indicating occasional divergences between news tone and price moves.

Recent Company History

Over the past months, IDEAYA reported several key milestones, including IND clearance for IDE034 and plans for a Phase 1 solid tumor trial starting in Q1 2026, inducement option grants, and participation in December 2025 investor events. The Q3 2025 update highlighted substantial cash and collaboration revenue. These events show an expanding pipeline and strengthened balance sheet. Today’s IND submission for IDE574 adds another early-stage asset alongside IDE034, extending the company’s focus on first-in-class oncology programs.

Market Pulse Summary

This announcement adds IDE574, a potential first-in-class KAT6/7 dual inhibitor, to IDEAYA’s pipeline, with a Phase 1 monotherapy trial targeted for 1Q 2026 and preclinical data expected in 1H 2026. It builds on recent IND progress for IDE034 and a strengthened balance sheet from collaboration revenues. Investors may watch for IND clearance outcomes, trial initiation, and early safety or pharmacologic readouts as key markers of future value for this program.

Key Terms

investigational new drug (IND) regulatory

"announced the submission of an investigational new drug (IND) application to the U.S."

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

u.s. food and drug administration (fda) regulatory

"IND application to the U.S. Food and Drug Administration (FDA) for IDE574"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

monotherapy medical

"Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

AI-generated analysis. Not financial advice.

• Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026
• Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026

SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026. 

"IDE574 is a promising potential first-in-class molecule that potently inhibits two tumor-promoting epigenetic modulators, KAT6 and KAT7, while sparing other structurally similar KAT family members. Preclinical studies demonstrate KAT6 and KAT7 collaboratively control lineage-specific tumorigenic transcription factor activity essential for tumor cell proliferation and survival. Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models dependent upon lineage-specific transcription factor activity," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.

IDE574 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026. 

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of IDE574, including combination therapies; (ii) the timing of initiating a Phase 1 dose escalation trial of monotherapy IDE574 and (iii) the timing of presenting pre-clinical data at a medical conference for IDE574. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs in early or late stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any 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 IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact

IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What did IDEAYA announce about IDE574 (IDYA) on December 10, 2025?

IDEAYA announced an IND submission to the FDA for IDE574, a potential first-in-class KAT6/7 dual inhibitor.

When will IDEAYA start the Phase 1 trial for IDE574 (IDYA)?

The company is targeting to begin a Phase 1 dose-escalation monotherapy trial in Q1 2026.

What preclinical results will IDEAYA present for IDE574 (IDYA) in 1H 2026?

IDEAYA plans to present preclinical pharmacologic profile and anti-tumor xenograft data for lung and breast cancer models in 1H 2026.

What is the mechanism of action for IDE574 (IDYA)?

IDE574 is described as an equipotent, highly selective small-molecule inhibitor of lysine acetyltransferases KAT6 and KAT7.

Which cancer types is IDE574 (IDYA) being considered for in early clinical evaluation?

IND-enabling studies support clinical evaluation in hormone receptor-positive breast cancer and lung adenocarcinoma, plus other lineage-addicted tumors.

Does IDEAYA report any human clinical data for IDE574 (IDYA) yet?

No; the announcement notes only preclinical data and a planned Phase 1 start in Q1 2026.