IDEAYA Biosciences Reports First Quarter 2026 Financial Results and Provides Business Update

Rhea-AI Summary

IDEAYA (Nasdaq: IDYA) reported Q1 2026 results and a business update highlighting a pivotal clinical win and strong liquidity. The Phase 2/3 OptimUM-02 darovasertib combination met its primary endpoint (HR 0.42; median PFS 6.9 vs 3.1 months).

The company plans an NDA submission in H2 2026 under FDA RTOR, multiple H2 2026 data readouts, and reported $972.9M cash as of March 31, 2026 with runway into 2030.

Positive

• OptimUM-02 primary endpoint met: HR 0.42 for PFS
• Median PFS 6.9 months vs 3.1 months (ICT)
• ORR 37.1% in darovasertib arm, including 5 CRs
• $972.9M cash runway guidance into 2030
• FDA RTOR agreement for NDA review in H2 2026

Negative

• R&D expense increased to $95.7M (Q1 2026)
• Net loss widened to $98.5M (Q1 2026)
• Collaboration revenue declined to $6.6M (Q1 2026)

News Market Reaction – IDYA

-0.35%

-0.35% Session close to close

In the May 5 session, IDYA declined 0.35%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Q1 2026 financials with detailed clinical progress. IDEAYA reported $972....

Analysis

This announcement combines Q1 2026 financials with detailed clinical progress. IDEAYA reported $972.9M in cash and securities, reaffirming runway into 2030, alongside strong OptimUM-02 results with a hazard ratio of 0.42 and median PFS of 6.9 vs 3.1 months. At the same time, R&D and G&A spending increased and net loss reached $98.5M. Investors may watch upcoming ASCO data, the planned NDA in H2 2026, and further updates on IDE849, IDE034, and MTAP-pathway programs.

Key Figures

Cash & securities: $972.9M Collaboration revenue: $6.6M Remaining R&D performance obligation: $155.3M +5 more

8 metrics

Cash & securities $972.9M As of March 31, 2026; runway guidance into 2030

Collaboration revenue $6.6M Three months ended March 31, 2026

Remaining R&D performance obligation $155.3M Future Servier clinical cost reimbursements as of March 31, 2026

R&D expenses $95.7M Q1 2026, up from $86.6M in Q4 2025

G&A expenses $19.4M Q1 2026, up from $18.8M in Q4 2025

Net loss $98.5M Three months ended March 31, 2026; vs $83.3M prior quarter

Hazard ratio 0.42 OptimUM-02 PFS, darovasertib combo vs ICT (95% CI: 0.30–0.59)

Median PFS 6.9 vs 3.1 months OptimUM-02, darovasertib combo vs investigator choice therapy

Previous Earnings Reports

5 past events · Latest: Feb 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 17	Earnings and update	Positive	+1.6%	Q4 2025 results with $1.05B cash and clear PFS readout timing.
Nov 04	Earnings and update	Positive	-2.8%	Q3 2025 results, $1.14B cash and major Servier upfront and revenue.
Aug 05	Earnings and update	Positive	-3.5%	Q2 2025 results showing $992M cash and broad clinical progress.
May 06	Earnings and update	Positive	-13.3%	Q1 2025 results highlighting $1.05B cash and pipeline expansion.
Feb 13	Earnings and update	Positive	-5.4%	FY 2024 update with $1.1B cash and advancing registrational trials.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases often highlight strong cash and pipeline progress, but the stock has more frequently traded down on these updates, with only one positive next-day move in the last five earnings events.

Recent Company History

Recent earnings and business updates for IDEAYA have consistently emphasized substantial cash reserves, funding runway into at least 2028–2030, and steady advancement of the darovasertib program plus multiple ADC and MTAP-pathway assets. Prior earnings on Feb 17, 2026 and throughout 2025 underscored enrollment progress in OptimUM-02 and new INDs, yet shares often pulled back afterward. Today’s Q1 2026 report again combines a strong balance sheet with detailed clinical timelines, fitting this pattern of catalyst-rich but volatility-prone updates.

Key Terms

progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), overall survival (OS), +4 more

8 terms

progression-free survival (PFS) medical

"achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months"

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

overall response rate (ORR) medical

"On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

duration of response (DOR) medical

"with a median duration of response (DOR) of 6.8 months."

Duration of response (DOR) measures how long a meaningful positive reaction to a treatment lasts before the disease worsens or returns. Think of it as a stopwatch that starts when a patient improves and stops when that improvement ends; longer times suggest a treatment’s benefit is more reliable. For investors, DOR helps judge a drug’s commercial staying power, pricing power, and likelihood of regulatory approval or broader adoption.

overall survival (OS) medical

"Overall survival (OS) data were not yet mature, however the darovasertib combination"

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.

blinded independent central review (BICR) medical

"in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR)."

A blinded independent central review (BICR) is a process in clinical trials where outside experts, who do not know which patients received the experimental treatment, centrally re-check key medical data (often images or test results) to confirm outcomes. Investors care because BICR reduces bias and disagreement in trial results—think of neutral referees reviewing game footage without team colors—so findings are more credible for regulators, partners and valuation decisions.

new drug application (NDA) regulatory

"A new drug application (NDA) submission to the U.S. Food and Drug Association (FDA) is planned"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

Real-Time Oncology Review (RTOR) regulatory

"under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program"

Real-Time Oncology Review (RTOR) is a regulatory program that lets drug regulators review key clinical data as it becomes available instead of waiting for a finished application, so the assessment can proceed in parallel with the company's final submission. For investors, RTOR matters because it can shorten the time between final data and a decision—like letting an inspector check a building while it's being finished—reducing approval uncertainty and potentially accelerating a therapy’s market entry and revenue timing.

antibody-drug conjugate medical

"IDE849 (DLL3 TOP1 ADC) and IDE034 (B7H3/PTK7 bispecific TOP1 ADC) planned for H2 2026"

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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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 13^th 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).
  • 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).
  • 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.
  • Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm.
  • 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.
  • 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.
  • 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 patients.
• In collaboration with Servier, IDEAYA successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial evaluating darovasertib in combination with crizotinib in the adjuvant setting of primary uveal melanoma. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment with darovasertib combined with crizotinib for 12-months or observation. The primary endpoint is superiority by relapse-free survival (RFS). OptimUM-11 is a global trial being conducted as part of IDEAYA's partnership with Servier and is expected to initiate in the first half of 2026.
• IDEAYA is continuing site activation and patient enrollment in the Phase 3 OptimUM-10 trial of neoadjuvant darovasertib in primary uveal melanoma. Full enrollment in the trial is estimated to be complete by the end of 2027, revised from prior guidance of first half of 2027.
  • IDEAYA is targeting to provide a clinical data update from the ongoing Phase 2 OptimUM-09 trial at a medical conference in the second half of 2026.

ADC / DDR combinations

• IDE849 (DLL3 TOP1 ADC): targeting to provide a clinical data update from the ongoing IDEAYA-sponsored global Phase 1/2 trial of IDE849 in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) by the end of 2026. The company is planning to initiate a monotherapy registrational trial by the end of 2026.
  • In April, IDEAYA entered into a clinical collaboration agreement with AstraZeneca plc to evaluate the efficacy and safety of IDE849 in combination with Imfinzi® (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, in extensive-stage SCLC. IDEAYA will sponsor the clinical combination trial; AstraZeneca will supply Imfinzi® at no cost.
  • Achieved first-patient-in (FPI) in Phase 1 combination trial of IDE849 and IDE161, IDEAYA's proprietary inhibitor of poly(ADP-ribose) glycohydrolase (PARG). Data from this trial are intended to help evaluate the potential synergy between TOP1 and PARG inhibition to drive deeper, more durable anti-tumor responses in patients
• IDEAYA's China-region partner, Jinagsu Hengrui Pharmaceuticals Co. Ltd., is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and provide a clinical update from their Phase 1 trial in SCLC and NEC at a medical conference in the second half of 2026.
• IDE034 (B7H3/PTK7 bispecific TOP1 ADC): achieved FPI in Phase 1 dose escalation trial to evaluate IDE034 in solid tumors, and is targeting to provide a clinical data update by the end of 2026. IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats.
  • Patient dosing triggered a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.

MTAP pathway

• IDE892 (PRMT5): achieved FPI in Phase 1 dose escalation trial of IDE892 in MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDEAYA is planning to initiate a Phase 1 combination cohort with IDE397, its proprietary MAT2A inhibitor, in MTAP-deleted cancers in mid-2026 and expansion in the second half of 2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.
• In March, IDEAYA announced it will deprioritize clinical activity with Gilead evaluating the combination of IDE397 and Trodelvy and conclude enrollment in the Phase 1/2 trial in MTAP-deleted urothelial and lung cancers.

Other programs

• IDE574 (KAT6/7): achieved FPI in Phase 1 dose escalation trial of IDE574 in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation.
• Following termination of the Collaboration, Option and License Agreement with GlaxoSmithKline in 2025, IDEAYA plans to discontinue development of IDE275, a small molecule inhibitor of Werner helicase (WRN), and IDE705, a small molecule inhibitor of Pol-Theta helicase (POLQ). The company is currently evaluating strategic options for these assets.

Corporate

• In February, IDEAYA announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer.  Dr. Ross will be responsible for leading early clinical development for IDEAYA's emerging oncology pipeline and play a crucial role in guiding the company's long-term R&D strategy.  She joins IDEAYA from AbbVie, where she served as Vice President, Head of Early Oncology R&D and Site Head for the Bay Area.
• As of March 31, 2026, IDEAYA had $972.9 million of cash, cash equivalents and marketable securities; current cash runway guidance into 2030 remains unchanged.   

Financial Results for the Quarter Ended March 31, 2026

As of March 31, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $972.9 million, compared to $1.05 billion as of December 31, 2025. The decrease was primarily driven by net cash used in operations.

Collaboration revenue for the three months ended March 31, 2026, totaled $6.6 million compared to $10.9 million for the three months ended December 31, 2025. Collaboration revenue was recognized for the performance obligations satisfied through March 31, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of March 31, 2026, the remaining balance for the research and development services performance obligations is $155.3 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended March 31, 2026 totaled $95.7 million compared to $86.6 million for the three months ended December 31, 2025. The increase was primarily driven by higher clinical trial and personnel-related expenses to support our programs.

General and administrative (G&A) expenses for the three months ended March 31, 2026 totaled $19.4 million compared to $18.8 million for the three months ended December 31, 2025. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities.

The net loss for the three months ended March 31, 2026, was $98.5 million compared to the net loss of $83.3 million for the three months ended December 31, 2025. Total stock compensation expense for the three months ended March 31, 2026, was $14.5 million compared to $11.8 million for the three months ended December 31, 2025.

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.  IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding IDEAYA Biosciences, Inc.'s ("IDEAYA") expectations with respect to the timing, progress, and results of its clinical trials and preclinical programs; the potential safety, efficacy, and therapeutic benefits of its product candidates; the planned presentation and publication of clinical data; the timing and likelihood of regulatory submissions, including the planned new drug application (NDA) for darovasertib and participation in the FDA's Real-Time Oncology Review (RTOR) program; the potential for accelerated approval and label expansion; the initiation, design, and enrollment of current and future clinical trials; the development and advancement of IDEAYA's pipeline programs, including IDE849, IDE034, IDE892, IDE397, and IDE574; the expected timing of clinical updates and milestones; the potential benefits of collaborations; and IDEAYA's financial position, including its expected cash runway.

These forward-looking statements are based on management's current expectations and assumptions and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks related to the timing, progress, and results of clinical trials and preclinical studies; the ability of IDEAYA to obtain and maintain regulatory approvals; uncertainties regarding the regulatory review process, including participation in the RTOR program; the potential for clinical data to differ from preliminary or interim results; the ability to successfully develop, manufacture, and commercialize product candidates; competition from other biotechnology and pharmaceutical companies; the impact of global economic conditions; 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 and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K.

Forward-looking statements speak only as of the date of this press release, and IDEAYA undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Investor and Media Contact

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

IDEAYA Biosciences, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)
		Three Months Ended
		March 31, 2026				December 31, 2025
		(Unaudited)
Collaboration revenue		$	6,560			$	10,876
Operating expenses:
Research and development			95,726				86,599
General and administrative			19,378				18,847
Total operating expenses			115,104				105,446
Loss from operations			(108,544)				(94,570)
Interest income and other income, net			10,005				11,297
Net loss			(98,539)				(83,273)
Unrealized (losses) gains on marketable securities			(2,761)				215
Comprehensive loss		$	(101,300)			$	(83,058)
Net loss per share    attributable to common    stockholders, basic and diluted		$	(1.11)			$	(0.94)
Weighted-average number of shares   outstanding, basic and diluted			88,699,754				88,582,694

IDEAYA Biosciences, Inc. Condensed Balance Sheet Data (in thousands)
		March 31,				December 31,
		2026				2025
		(Unaudited)
Cash and cash equivalents and short-term and long-term marketable securities		$	972,914			$	1,049,685
Total assets			1,030,348				1,109,324
Total liabilities			93,081				86,390
Total liabilities and stockholders' equity		$	1,030,348			$	1,109,324

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What did IDEAYA (IDYA) announce about the OptimUM-02 trial on May 5, 2026?

The OptimUM-02 registrational trial met its primary endpoint with a HR of 0.42 and median PFS 6.9 months versus 3.1 months. According to the company, the result supports an NDA submission planned in H2 2026 under FDA RTOR review.

When does IDEAYA plan to submit an NDA for darovasertib (IDYA) and under which program?

IDEAYA plans an NDA submission in H2 2026 and will use the FDA OCE RTOR program for review. According to the company, RTOR allows pre-submission of components to enable a more efficient review timeline.

How much cash did IDEAYA report on March 31, 2026 and how long is the runway?

IDEAYA reported approximately $972.9 million in cash, cash equivalents and marketable securities as of March 31, 2026. According to the company, this cash position supports its current runway guidance into 2030.

What clinical readouts should investors expect from IDEAYA (IDYA) in H2 2026?

Investors should expect late-breaking ASCO data for OptimUM-02 and updates for HLA*A2-positive darovasertib, IDE849, and IDE034 in H2 2026. According to the company, those readouts will inform regulatory and registrational plans.

What were IDEAYA's key financial trends in Q1 2026 that investors should note?

Q1 2026 showed higher R&D spending of $95.7M and a net loss of $98.5M versus prior quarter results. According to the company, the increases were driven by clinical and personnel-related investments supporting program advancement.