IDEAYA Biosciences Provides a Business Update and Outlines 2026 Corporate Objectives at the 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ: IDYA) outlined 2026 objectives focused on advancing registrational trials, ADC+DDR combinations, MTAP-pathway programs and next-generation therapies. Key milestones include topline PFS results from the Phase 2/3 OptimUM-02 darovasertib+crizotinib trial in Q1 2026 that could enable a potential accelerated approval, initiation or enrollment milestones across multiple darovasertib Phase 3 trials by H1 2026, IND clearance for IDE574 in January 2026 with a planned Phase 1 start in Q1 2026, and multiple INDs/starts for IDE034, IDE161, IDE892, IDE397 and IDE849 through 2026. The company reported approximately $1.1 billion in cash and marketable securities as of 9/30/25, expected to fund operations into 2030.

Positive

• $1.1 billion cash and marketable securities (9/30/25) funding into 2030
• Topline PFS readout Q1 2026 could enable a potential accelerated approval
• IND clearance for IDE574 in Jan 2026; Phase 1 start targeted Q1 2026
• Plan to advance four registrational trials in 2026 including IDE849 and darovasertib

Negative

• Regulatory and commercial progress depends on positive clinical trial outcomes

Key Figures

INDs filed in 2025: 4 INDs Clinical programs: 9 programs OptimUM-02 PFS events: 130 events +5 more

8 metrics

INDs filed in 2025 4 INDs Resulting in nine clinical programs as of 2025

Clinical programs 9 programs Pipeline breadth referenced in 2026 objectives

OptimUM-02 PFS events 130 events Randomized PFS analysis in ITT population

OptimUM-02 randomization 313 patients, 2:1 ratio Phase 2b/3 ITT population treatment vs control

OptimUM-02 full enrollment 437 patients Registrational metastatic uveal melanoma trial

OptimUM-10 enrollment target ≈450 patients Neoadjuvant uveal melanoma Phase 3 trial by H1 2027

OptimUM-01 enrollment ≈80 patients HLA*A2-positive mUM Phase 2 combination trial

Cash and securities ~$1.1 billion As of 09/30/25; runway expected into 2030

Market Reality Check

Price: $34.75 Vol: Volume 1,254,417 vs 20-da...

normal vol

$34.75 Last Close

Volume Volume 1,254,417 vs 20-day average 939,231, indicating elevated trading interest ahead of the 2026 objectives. normal

Technical Shares at $37.38, trading above the 200-day MA $25.32 and about 4.84% below the 52-week high of $39.28.

Peers on Argus

IDYA gained 2.61% while close peers were mixed: DNLI (-1.78%), BLTE (-3.47%), TV...

IDYA gained 2.61% while close peers were mixed: DNLI (-1.78%), BLTE (-3.47%), TVTX (-2.43%), GLPG (+0.18%), FOLD (flat). This points to a stock-specific reaction to the corporate update rather than a broad biotech move.

Historical Context

5 past events · Latest: Jan 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Conference participation	Positive	+3.2%	Announced upcoming J.P. Morgan Healthcare Conference presentation and webcast access.
Dec 11	Clinical trial progress	Positive	-0.2%	Reported full enrollment of pivotal OptimUM-02 darovasertib plus crizotinib trial.
Dec 10	IND submission	Positive	-1.3%	Submitted IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor.
Dec 04	IND clearance	Positive	+4.7%	Partner Biocytogen announced FDA IND clearance for bispecific ADC IDE034.
Dec 01	IND clearance	Positive	-3.7%	IDEAYA announced FDA IND clearance for IDE034 targeting multiple solid tumors.

Pattern Detected

Recent fundamentally positive updates often produced mixed reactions, with three instances of negative/flat moves versus two positive moves following generally constructive news.

Recent Company History

Over the last six weeks, IDEAYA reported several pipeline and corporate milestones. In December 2025, the company completed targeted full enrollment in the pivotal OptimUM-02 darovasertib trial and advanced multiple INDs, including IDE034 and IDE574. Price reactions ranged from a 4.69% gain on IDE034-related news to a -3.68% decline on a similar IND clearance, underscoring inconsistent trading responses. Today’s broad 2026 objectives and cash runway commentary build directly on that expanding late-stage and early-stage oncology pipeline.

Market Pulse Summary

This announcement outlines IDEAYA’s 2026 objectives, highlighting four planned registrational trials...

Analysis

This announcement outlines IDEAYA’s 2026 objectives, highlighting four planned registrational trials, multiple new Phase 1 starts, and a reported cash position of about $1.1 billion supporting operations into 2030. It builds on recent milestones such as OptimUM‑02 full enrollment and several IND clearances. Investors may focus on upcoming PFS and OS readouts, enrollment timelines across OptimUM trials, and initial data from new ADC and MTAP-pathway programs as key validation points.

Key Terms

investigational new drug (ind), progression free survival (pfs), overall survival (os), intent-to-treat population (itt), +4 more

8 terms

investigational new drug (ind) regulatory

"Submit an investigational new drug (IND) application for a potential first-in-class"

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.

progression free survival (pfs) medical

"Topline results, including progression free survival (PFS) data, from ongoing"

Progression free survival (PFS) is the amount of time after a treatment starts during which a patient’s disease does not get worse. Investors watch PFS because it’s a commonly reported measure in clinical trials that can indicate a drug’s effectiveness earlier than overall survival, much like measuring how long a dam holds before leaks reappear; stronger PFS results can speed regulatory decisions and affect a drug’s commercial prospects.

overall survival (os) medical

"full enrollment of 437 patients complete; overall survival (OS) data expected"

Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.

intent-to-treat population (itt) medical

"events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3"

The intent-to-treat population (ITT) includes every person who was originally assigned to a treatment group in a clinical trial, regardless of whether they completed the study or followed the treatment plan. It matters to investors because ITT analyses give a conservative, real-world view of a drug’s effectiveness and safety—like judging a movie by everyone who bought a ticket, not just those who stayed to the end—and can strongly influence regulatory decisions and commercial prospects.

antibody-drug conjugate (adc) medical

"Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations"

An antibody-drug conjugate (ADC) is a targeted medical treatment that combines an antibody, which acts like a guided missile seeking out specific cells, with a powerful drug to destroy those cells. It is designed to deliver medication directly to diseased cells, minimizing damage to healthy tissue. For investors, ADCs represent innovative therapies with potential for high growth, especially if they prove effective in treating difficult-to-cure conditions.

dna damage response (ddr) medical

"Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations"

The DNA damage response (DDR) is a cell's built‑in system for detecting, signaling and fixing breaks or errors in its genetic code—think of it as a surveillance alarm and repair crew for DNA. For investors, DDR matters because therapies, tests or drugs that affect these repair systems can change how diseases are treated, create new market opportunities or influence safety and regulatory outcomes, so progress or setbacks in DDR programs can meaningfully affect company value.

monotherapy medical

"Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer"

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.

phase 3 medical

"Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, provided a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST.

"2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma - one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

2026 Corporate Objectives

Darovasertib in uveal melanoma (UM)

• Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 '26
  • Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States
• Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26
  • OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM
  • OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27
  • OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 '26
• Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 '26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset

Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations

• IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026
• IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 '26
• IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26

MTAP Pathway

• IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026
• IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 '26
• Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA's dual KAT6/7 inhibitor

Next Generation Therapies

• IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 '26

Corporate

• ~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030
• Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier

IDEAYA's updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: https://ir.ideayabio.com/.

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 IDEAYA therapeutics; (ii) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts, including those at medical conferences; (iii) the potential and timing for an accelerated approval filing for darovasertib; (iv) the timing of darovasertib in three Phase 3 registrational trials across all stages of UM; (v) the utilization of OS data to support a potential full approval filing for darovasertib; (vi) the timing of initiating registrational studies and other clinical trials for IDEAYA therapeutics; (vii) the timing of patient enrollments in clinical trials; (viii) the timing of IND submissions for IDEAYA therapeutics; and (iv) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its current operating plan. 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 current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025.

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

When will IDEAYA (IDYA) report topline PFS results for darovasertib OptimUM-02?

Topline PFS results for OptimUM-02 are expected in Q1 2026.

What could a positive OptimUM-02 PFS readout mean for IDYA (IDYA)?

A positive topline PFS readout could support a potential accelerated approval filing in the U.S.

How long is IDEAYA's cash runway reported for IDYA?

IDEAYA reported approximately $1.1 billion in cash and securities as of 9/30/25, expected to fund operations into 2030.

Which registrational trials does IDEAYA plan to advance in 2026 for IDYA?

Plans include four registrational trials in 2026, notably IDE849 (DLL3 TOP1 ADC) and darovasertib programs across uveal melanoma settings.

What IND and clinical starts are planned by IDEAYA (IDYA) in early 2026?

Targets include Phase 1 starts or IND-based initiations for IDE574, IDE034, IDE161, and IDE892 in Q1–Q2 2026.

Will darovasertib trials include both metastatic and pre-metastatic uveal melanoma?

Yes; darovasertib registrational trials are planned across pre-metastatic and metastatic uveal melanoma by H1 2026.