IDEAYA Biosciences
NasdaqGS:IDYA
$
33,85
$
$-0,72 (-2,08%)
33,85
$
$-0,72 (-2,08%)
End-of-day quote: 01/02/2026
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IDEAYA Biosciences Company Info
EPS Growth 5Y
0,00%
Market Cap
$2,97 B
Long-Term Debt
$0,00 B
Short Interest
7,85%
Annual earnings
02/13/2026
Dividend
$0,00
Dividend Yield
0,00%
Founded
2015
Industry
Country
ISIN Number
Website
Analyst Price Target
$48,00
41.8%
Last Update: 01/04/2026
Analysts: 17
Highest Price Target $79,00
Average Price Target $48,00
Lowest Price Target $31,00
In the last five quarters, IDEAYA Biosciences’s Price Target has fallen from $42,12 to $38,40 - a -8,83% decrease. Seventeen analysts predict that IDEAYA Biosciences’s share price will increase in the coming year, reaching $48,00. This would represent an increase of 41,80%.
Top growth stocks in the health care sector (5Y.)
What does IDEAYA Biosciences do?
IDEAYA Biosciences, Inc. operates as a precision medicine oncology company. The company is committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.
The company's clinical pipeline includes six potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE849 (DLL3), IDE275 / GSK959 (Werner Helicase), IDE161 (PARG), and IDE705 / GSK101 (Pol Theta Helicase). The company owns or controls...
IDEAYA Biosciences, Inc. operates as a precision medicine oncology company. The company is committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.
The company's clinical pipeline includes six potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE849 (DLL3), IDE275 / GSK959 (Werner Helicase), IDE161 (PARG), and IDE705 / GSK101 (Pol Theta Helicase). The company owns or controls all commercial rights to three of these product candidates: darovasertib, IDE397, and IDE161, and owns or controls all commercial rights outside of greater China for IDE849. The company is also advancing several development candidates, including IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor for which it is targeting an investigational new drug, or IND, filing in mid-year 2025; IDE034, a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload bispecific antibody drug conjugate, or BsADC, program for which it is targeting an IND filing in the second half of 2025; and IDE251, a potential first-in-class KAT6/7 dual inhibitor program for which it is targeting an IND filing in the second half of 2025. The company also has multiple earlier-stage preclinical programs. The company has established selective, value-accretive collaborations with leading pharmaceutical companies to support its clinical development activities.
Darovasertib (GNAQ or GNA11 Mutations)
Darovasertib (IDE196) is the company's most advanced clinical-stage product candidate, which it in-licensed from Novartis. Darovasertib is a potent, selective small molecule inhibitor of protein kinase C, or PKC, which the company is developing for genetically defined cancers having GNAQ or GNA11 gene mutations. PKC is a protein kinase that functions downstream of the GTPases GNAQ and GNA11.
The company has enrolled over 230 patients as of February 7, 2025, and has opened multiple clinical sites, including international sites, in its potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002. The purpose of the clinical trial is to evaluate darovasertib in combination with crizotinib, Pfizer’s investigational cMET inhibitor, in patients having metastatic uveal melanoma, or MUM, with human leukocyte antigen-, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of a second Clinical Trial Collaboration and Supply Agreement, or the Second Pfizer Agreement, with Pfizer.
In December 2024, the company announced the recommendation of a move-forward dose and the completion of the Part 2a dose optimization for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line, or 1L, setting in patients with HLA-A2(-) MUM. The company is targeting a median progression free survival, or PFS, readout for the Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM by year-end 2025.
The company is enrolling additional HLA-A 02:01 positive, or HLA-A2(+), patients as an independent clinical strategy to address HLA-A2(+) MUM patients, in the company’s ongoing Phase 2 clinical trial, designated as IDE196-001.
The company is targeting a median overall survival, or OS, readout from its Phase 2 clinical trial, designated as IDE196-001, in approximately 40 1L MUM patients in 2025.
The company has enrolled 95 patients as of December 31, 2024, in its Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary uveal melanoma, or UM, with ongoing enrollment and multiple clinical sites open. The company is targeting a clinical data update in over 75 patients and regulatory update(s) in the first half of 2025, including vision data in plaque brachytherapy patients.
In September 2024, the company announced interim clinical data from the ongoing Phase 2 company-sponsored trial and provided a regulatory update on a potential Phase 3 registration-enabling clinical trial in neoadjuvant UM patients based on a Type C meeting held with the U.S. Food and Drug Administration, or FDA. Based on the FDA meeting, the company currently projects that approximately 400 patients will be randomized for treatment with darovasertib in the treatment arm or the control arm, with potential modifications pending further feedback from the FDA. The company is currently finalizing the trial protocol for neoadjuvant UM and is targeting to initiate the study in the first half of 2025.
The company is also supporting the evaluation of darovasertib as single-agent neoadjuvant and adjuvant therapy in primary UM in an ongoing investigator-sponsored clinical trial, or IST, captioned as Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma, or NADOM, led by St. Vincent’s Hospital in Sydney, with the participation of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.
IDE397 (MTAP Gene Deletion)
IDE397, the company's small molecule methionine adenosyltransferase 2a, or MAT2A, inhibitor, is being evaluated in a Phase 1/2 clinical trial. The company has selected a move-forward Phase 2 expansion dose for IDE397 monotherapy, based on the adverse event, or AE, profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1. The company is enrolling patients with an initial focus on MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC.
In July 2024, the company announced clinical data for the IDE397 Phase 2 monotherapy expansion dose demonstrating preliminary clinical efficacy in heavily pre-treated MTAP-deletion UC and NSCLC patients.
The company is collaborating with Gilead Sciences, Inc., or Gilead, to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab-govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients having MTAP-deletion UC, in its Phase 1 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or Gilead CSCSA, with Gilead. A first patient was dosed for the Phase 1 trial in June 2024.
In October 2024, the company reported the first preliminary clinical case study of the IDE397 and Trodelvy combination in MTAP-deletion UC at ENA 2024, including a partial response by RECIST 1.1 in a patient case report with a genetic co-alteration of MTAP-deletion and a FGFR3-TACC3 fusion, and rapid and deep first-evaluation molecular responses, or MRs, with ctDNA reduction of greater than 95% observed. The partial response reported at ENA 2024 has confirmed by RECIST 1.1. the company is targeting a Phase 1/2 expansion in the first quarter of 2025 and a clinical data update for the Phase 1 trial in MTAP-deletion UC in 2025.
In February 2025, the company expanded its clinical study collaboration and entered into a Clinical Study Collaboration and Supply Agreement, or the Second Gilead CSCSA, to evaluate the IDE397 and Trodelvy combination in MTAP-deletion NSCLC.
The company is collaborating with Amgen to clinically evaluate IDE397 in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having tumors with MTAP-deletion, in an Amgen-sponsored clinical trial pursuant to its Clinical Trial Collaboration and Supply Agreement with Amgen, or the Amgen CTCSA. The company and Amgen mutually agreed to wind down the IDE397 and AMG 193 clinical combination study in February 2025 and will not pursue dose expansion.
In October 2024, the company presented a preclinical poster presentation on the antitumor activity achieved by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors at the EORTC-NCI-AACR Symposium, or ENA 2024. The company is targeting to enable its wholly-owned clinical combination of IDE397 and IDE892, its potential best-in-class MTA-cooperative PRMT5 inhibitor development candidate, in the second half of 2025 in MTAP-deletion NSCLC.
IDE849 / SHR-4849 (DLL3 ADC program)
In December 2024, the company entered into an exclusive License Agreement, or the Hengrui Pharma License Agreement, with Jiangsu Hengrui Pharmaceuticals Co., Ltd., or Hengrui Pharma, pursuant to which Hengrui Pharma granted the company an exclusive worldwide license outside of Greater China for IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC. Under the terms of the Hengrui Pharma License Agreement.
IDE849 is currently being evaluated by Hengrui Pharma in an ongoing Phase 1 trial in China in small cell lung cancer, or SCLC, patients. In preliminary results from the trial, 8 out of 11 evaluable patients achieved partial response by RECIST 1.1. In January 2025, Hengrui Pharma selected expansion doses for the Phase 1 trial.
The company is planning to submit a U.S. IND for the evaluation of IDE849 as a monotherapy in SCLC in the first half of 2025. The company is also targeting to initiate the evaluation of IDE849 in combination with IDE161 and in neuroendocrine tumors, or NETs, in the second half of 2025. A clinical data update is targeted for 2025.
IDE275 / GSK959 (WRN Program - High Microsatellite Instability)
In October 2024, GSK initiated a Phase 1 clinical trial for IDE275 (GSK959), following the submission of the GSK-sponsored IND and FDA allowance to proceed with the clinical trial. IDE275 (GSK959) targets the helicase domain of the Werner, or WRN, protein, for patients having tumors with high microsatellite instability, or MSI-High. GSK will lead clinical development for the Werner Helicase program.
IDE161 (HRD, including BRCA)
IDE161 is the company's potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor. The company is progressing with the enrollment of patients having tumors with homologous recombination deficiency, or HRD, into the Phase 1 expansion portion of the Phase 1/2 clinical trial. The company selected an initial Phase 1/2 monotherapy expansion dose for IDE161 in endometrial cancer, based on the AE profile and preliminary efficacy observed. In parallel, the company is also continuing with Phase 1 dose optimization to confirm a move-forward expansion dose for the planned Phase 2 portion of the clinical trial.
In March 2024, the company entered into a Clinical Trial Collaboration and Supply Agreement, or the Merck CTCSA, with Merck (known as MSD outside of the United States and Canada). The company is evaluating IDE161 in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with MSI-High and microsatellite stable, or MSS, endometrial cancer.
The company received Fast Track Designations from the FDA in September 2023 for IDE161, specifically for the treatment of (i) adult, pretreated, platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and (ii) adult, pretreated, advanced or metastatic hormone receptor positive, or HR+, Her2- and BRCA1/2 mutant breast cancer patients.
IDE705 / GSK101 (Pol Theta Program - HR mutations, including BRCA, or HRD)
Enrollment is ongoing in the Phase 1 dose escalation portion of the GSK-sponsored study. IDE705 (GSK101) targets the helicase domain of the Pol Theta protein for patients having solid tumors with BRCA or other mutations associated with HRD. GSK is leading clinical development of IDE705 (GSK101). GSK is clinically evaluating IDE705(GSK101) in a GSK-sponsored dose escalation trial in combination with niraparib, the GSK small molecule inhibitor of poly-(ADP-ribose) polymerase, or PARP, in solid tumors.
IDE892 (MTA-cooperative PMRT5 inhibitor)
In December 2024, the company selected IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, as a development candidate. IDE892 is a potent and selective MTA-cooperative PRMT5 inhibitor with favorable ADME properties, demonstrating robust MTAP deletion-specific pathway suppression and highly durable antitumor activity in combination with IDE397 IND-enabling studies.
Subject to the successful completion of ongoing IND-enabling studies for IDE892, the company is targeting an IND submission in mid-year 2025. The company is also targeting to enable its wholly-owned clinical combination of IDE397 and IDE892 in the second half of 2025 in MTAP-deletion NSCLC.
IDE034 (B7H3 / PTK7 BsADC program)
In July 2024, the company entered into an Option and License Agreement, or the Biocytogen Option and License Agreement, with Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), or Biocytogen, pursuant to which Biocytogen granted the company an option for an exclusive worldwide license for a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload bispecific antibody drug conjugate, or BsADC, program, or the Option.
In November 2024, the company announced the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of the Option. Pursuant to the Biocytogen Option and License Agreement.
Subject to the successful completion of ongoing IND-enabling studies for IDE034, the company is targeting an IND submission in the second half of 2025.
IDE251 (KAT6/7 inhibitor)
In December 2024, the company selected IDE251, a potential first-in-class KAT6/7 inhibitor, as a development candidate. IDE251 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.
Subject to the successful completion of ongoing IND-enabling studies for IDE251,the company is targeting an IND submission in the second half of 2025.
Precision Medicine Research Platform
The company has established a robust precision medicine research platform with capabilities for the identification and validation of new targets and biomarkers, drug discovery, and translational biology. The company's approach integrates small molecule drug discovery with extensive capabilities in identifying and validating translational biomarkers to develop targeted therapies for select patient populations that are most likely to benefit from these targeted therapies.
The company owns or controls all commercial rights in programs directed to targets identified in its new target and biomarker discovery platform.
The drug discovery platform includes its proprietary chemical library, INQUIRE, structure-based drug design enabled by extensive structural biology and crystallography capabilities, and its proprietary content-based machine-learning engine, HARMONY, providing effective and efficient molecular design and structure-activity-relationship, or SAR, cycles.
Other Pipeline Programs (Defined Biomarkers)
The company has initiated early preclinical research programs focused on pharmacological inhibition of several new targets, or NTs, for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures. The company believes these research programs have the potential for the discovery and development of first-in-class, unique-in-class, or best-in-class therapeutics.
The company owns or controls all commercial rights in its next-generation programs.
New Target and Biomarker Discovery Platform
The company has invested significantly and continues to invest in capabilities for the identification and validation of new precision medicine targets and biomarkers for patient selection. For targets of interest, the company advances its research to discover therapeutic drugs and to further qualify relevant biomarkers.
The company owns or controls all commercial rights in programs directed to targets identified in its new target and biomarker discovery platform.
Darovasertib – PKC Inhibitor Clinical Candidate in Uveal Melanoma
Darovasertib (IDE196) is the company's most advanced clinical-stage product candidate, which it in-licensed from Novartis. Darovasertib is a potent, selective small molecule inhibitor of PKC, which the company is developing for genetically defined cancers having GNAQ or GNA11 gene mutations. PKC is a protein kinase that functions downstream of the GTPases GNAQ and GNA11.
The company has enrolled over 230 patients as of February 7, 2025, and has opened multiple clinical sites, including international sites, in its potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002. The purpose of the clinical trial is to evaluate darovasertib in combination with crizotinib, Pfizer’s investigational cMET inhibitor, in patients having MUM with human leukocyte antigen, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of the Second Pfizer Agreement with Pfizer.
In December 2024, the company announced the recommendation of a move-forward dose and the completion of the Part 2a dose optimization for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line, or 1L setting in patients with HLA-A2(-) MUM.
The company is enrolling additional HLA-A*02:01 positive, or HLA-A2(+), patients as an independent clinical strategy to address HLA-A2(+) MUM patients in its ongoing Phase 2 clinical trial, designated as IDE196-001.
The company is targeting a median OS readout from its Phase 2 clinical trial, designated as IDE196-001, in approximately 40 1L MUM patients in 2025.
The company has enrolled 95 patients as of December 31, 2024, in its Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary UM, with ongoing enrollment and multiple clinical sites open. In September 2024, the company announced interim clinical data from the ongoing Phase 2 company-sponsored trial and provided a regulatory update on a registrational trial based on a Type C meeting held with the FDA.
ASCO 2024 Clinical Data from Investigator-Sponsored Phase 2 Trial
In its ongoing investigator-sponsored Phase 2 trial of darovasertib as neoadjuvant/adjuvant treatment in UM, the company has treated 15 patients planned for enucleation with localized UM twice daily with a 300 mg dose of darovasertib as of May 14, 2024. An initial safety cohort of three patients was treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months with darovasertib as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy, or external beam radiotherapy, or EBRT) across three Australian centers.
Company-Sponsored Phase 2 Trial
In September 2024, the company provided a clinical data update in which it observed encouraging clinical activity in its Phase 2 company-sponsored trial. Collectively with the IST trial, the clinical efficacy data from the Phase 2 company-sponsored trial substantiate clinical proof of concept for the use of darovasertib in the neoadjuvant uveal melanoma setting. The Phase 2 company-sponsored trial used a data cutoff date of August 15, 2024, with an enrollment cutoff date of May 13, 2024.
The company is pursuing a clinical strategy for darovasertib to broadly address UM, alternatively referred to as ocular melanoma, in both primary and metastatic settings. Greater than 90% of UM patients have tumors harboring GNAQ or GNA11 mutations. There are no FDA-approved systemic therapies for primary UM, either as neoadjuvant or adjuvant therapies. There are likewise no FDA-approved therapies for patients having MUM with HLA-A02:01 negative, or HLA-A2(-), serotype. These primary UM patients and HLA-A2(-) MUM patients collectively represent approximately 85% of all ocular melanoma patients. The company has a separate, independent clinical strategy to address HLA-A02:01 positive, or HLA-A2(+), MUM patients.
The company owns or controls all commercial rights in its darovasertib program in UM, including in MUM and in primary UM, subject to certain economic obligations pursuant to its exclusive, worldwide license to darovasertib with Novartis.
Darovasertib – Potential Registration-Enabling Clinical Trial in First-Line HLA-A2(-) MUM
In December 2024, the company announced the recommendation of a move-forward dose and the completion of the Part 2a dose optimization for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the 1L setting in patients with HLA-A2(-) MUM.
In May 2023, the company expanded its relationship with Pfizer to support the Phase 2/3 registrational trial to evaluate darovasertib and crizotinib as a combination therapy in MUM by entering into Amendment No. 1 to the Second Pfizer Agreement. Under Amendment No. 1 to the Second Pfizer Agreement, Pfizer will provide the company with a first defined quantity of crizotinib, as well as an additional second defined quantity of crizotinib at a lump-sum cost.
Darovasertib – Strategy for HLA-A*02:01 Positive MUM
Based on clinical data from the Phase 2 clinical trial evaluating darovasertib and crizotinib in MUM as reported at ESMO 2023, and based on the darovasertib mechanism of action, the company anticipates darovasertib will have clinical activity independent of HLA-A2 status in GNAQ/11-mutation cancers.
The company is enrolling additional HLA-A2(+) MUM patients as an independent clinical strategy to address HLA-A2(+) MUM patients, in its ongoing Phase 2 clinical trial, designated as IDE196-001. This strategy demonstrates the company’s commitment to fully address the high unmet medical need in MUM. Such clinical trial data from darovasertib and crizotinib combination treatment in HLA-A2(+) MUM could support publication and potential inclusion in NCCN Clinical Practice Guidelines in Oncology.
Darovasertib – Orphan Drug Designation in UM and Fast Track Designation in MUM
In April 2022, the FDA designated darovasertib as an Orphan Drug in UM, including primary and metastatic disease. Under an Orphan Drug designation, darovasertib may be entitled to certain tax credits for qualifying clinical trial expenses, exemption from certain user fees and, subject to FDA approval of a New Drug Application, or NDA, for darovasertib in UM, eligibility for seven years of statutory marketing exclusivity during which the FDA is prohibited from approving a subsequent same drug for the same rare disease or condition except in limited circumstances, such as a subsequent drug that demonstrates clinical superiority.
In November 2022, the FDA granted Fast Track designation to the company’s development program investigating darovasertib in combination with crizotinib in adult patients being treated for MUM. The Fast Track designation makes its darovasertib and crizotinib development program eligible for various expedited regulatory review processes, including generally more frequent FDA interactions, such as meetings and written communications, potential eligibility for rolling review of a future NDA and potential accelerated approval and priority review of an NDA.
Darovasertib – Phase 2 Trials in Neoadjuvant and Adjuvant Therapy in Uveal Melanoma (UM)
The company is clinically evaluating the potential for darovasertib as neoadjuvant or adjuvant therapy, or both, also referred to as (neo)adjuvant therapy, in primary, non-metastatic UM patients.
The company is clinically evaluating the potential for darovasertib as neoadjuvant or adjuvant therapy, or both, also referred to as (neo)adjuvant therapy, in primary, non-metastatic UM patients. The company previously reported preliminary clinical data in the neoadjuvant setting showing evidence of anti-tumor activity.
The company has enrolled 95 patients as of December 31, 2024, in its Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary UM, with ongoing enrollment and multiple clinical sites open. The purpose of the clinical trial is to evaluate single-agent darovasertib as neoadjuvant treatment of primary UM prior to primary interventional treatment of enucleation or radiation therapy, and also as adjuvant therapy following the primary treatment. An amendment to the study protocol was submitted to the FDA in July 2024 to enable dosing of darovasertib therapy for up to 12 months.
The company is additionally supporting the evaluation of darovasertib as (neo)adjuvant therapy in primary UM in the ongoing NADOM IST. Pursuant to an as-amended protocol for the NADOM study, UM patients who would otherwise undergo enucleation are instead treated with single-agent darovasertib as neoadjuvant treatment for up to six months or until maximum benefit. This reflects an increase in potential treatment duration versus the initial approach of one month of neoadjuvant therapy, following which these patients will undergo a primary interventional treatment. Patients will subsequently be treated with darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment.
IDE397 – MAT2A Inhibitor in Tumors with MTAP Deletion
IDE397 is a clinical-stage, potent, selective small molecule inhibitor of methionine adenosyltransferase 2a, or MAT2A, which the company is developing for patients having solid tumors with MTAP deletion. The prevalence of methylthioadenosine phosphorylase, or MTAP, gene deletion is estimated to be approximately 15% of human solid tumors. MTAP deletion in patient tumors is identified by commercial or institutional next generation sequencing, or NGS, panels or by MTAP immunohistochemistry, or IHC, assay with confirmation by NGS.
The company is enrolling patients into a Phase 1/2 clinical trial, designated as IDE397-001, to evaluate IDE397 for patients having certain tumors with MTAP gene deletion. The company is proceeding with the enrollment of MTAP-deletion patients into a monotherapy Phase 1/2 expansion cohort with an initial focus on high-priority solid tumor types, including UC and NSCLC. The company has selected a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion UC and NSCLC, based on the AE profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1.
Company-Sponsored Phase 1/2 Monotherapy Expansion in MTAP-Deletion Urothelial and Lung Cancer
In July 2024, the company announced clinical data for the IDE397 Phase 1/2 monotherapy expansion dose demonstrating preliminary clinical efficacy in heavily pre-treated MTAP-deletion UC and NSCLC patients. The patients evaluated had a median of two prior lines of therapy, ranging from one to seven prior lines of treatment. The reported Phase 1/2 clinical data were based on 18 evaluable MTAP-deletion patients, including seven UC patients, four adenocarcinoma squamous NSCLC patients, and seven squamous NSCLC patients at the expansion dose of 30 mg once a day, or QD, of IDE397. In the interim update for 18 evaluable patients, with a data analysis cutoff date of June 21, 2024, the company reported an overall response rate of approximately 39% (one complete response and six partial responses by RECIST 1.1 evaluation), which included two unconfirmed partial responses (one UC patient that had a 100% tumor reduction in the target lesion at the last CT-scan assessment and one adenocarcinoma squamous NSCLC patient, which were both confirmed in the company's October 2024 update).
Regarding safety data, the company also reported a favorable AE profile at the 30 mg QD expansion dose. Approximately 5.6% of patients experienced a Grade 3 or higher drug-related AE at the 30 mg QD dose, represented by one instance of Grade 3 asthenia, and no drug-related SAEs were observed. The company observed no drug-related AEs leading to discontinuations, and one non-evaluable patient discontinued due to rapid clinical progression of cancer fatigue and drug-unrelated AEs in the first cycle of treatment. The company anticipates that the favorable AE profile and dosing convenience of a 30 mg QD tablet has the potential to enable long-term dosing and combination development.
In October 2024, the company announced Phase 1 expansion data for IDE397 in MTAP-deletion UC and NSCLC patients in a late breaker abstract oral presentation at the 36th edition of the EORTC-NCI-AACR Symposium, or ENA 2024, in Barcelona, Spain. The patients evaluated had a median of two to three prior lines of therapy, ranging from one to seven prior lines of treatment.
The company continued to report a favorable AE profile at the 30 mg QD expansion dose. Approximately 18% of patients experienced a Grade 3 or higher drug-related AE at the 30 mg QD dose, and no drug-related SAEs were observed. No drug-related AEs leading to discontinuations were noted. The company anticipates that the favorable AE profile and dosing convenience of a 30 mg QD tablet have the potential to enable long-term dosing and combination development, including with MTA-cooperative PRMT5 inhibitors and topoisomerase payload ADCs.
The company is collaborating with Gilead to clinically evaluate IDE397 and Trodelvy (sacituzumab-govitecan-hziy), Gilead’s Trop-2 directed ADC combination, in patients having MTAP-deletion UC, in its Phase 1 clinical trial pursuant to the Gilead CSCSA, with Gilead.
A first patient was dosed for the Phase 1 trial in June 2024. The Phase 1 clinical trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy in MTAP-deletion UC patients (NCT04794699). Pursuant to the Gilead CSCSA, the company and Gilead retain the commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. The company is the study sponsor, and Gilead will provide the supply of Trodelvy. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency, and the efficacy and safety of this combination has not been established.
In October 2024, the company reported the first preliminary clinical case study of the IDE397 and Trodelvy combination in MTAP-deletion UC at ENA 2024, including a partial response by RECIST 1.1 in a patient case report with a genetic co-alteration of MTAP-deletion and a FGFR3-TACC3 fusion, and rapid and deep first-evaluation MRs with ctDNA reduction of greater than 95% observed. The partial response reported at ENA 2024 has been confirmed by RECIST 1.1. The company is targeting a Phase 1/2 expansion in the first quarter of 2025 and a clinical data update for the Phase 1 trial in MTAP-deletion UC in 2025.
In February 2025, the company expanded its clinical study collaboration and entered into the Second Gilead CSCSA to evaluate the IDE397 and Trodelvy combination in MTAP-deletion NSCLC.
The company were collaborating with Amgen to clinically evaluate IDE397 in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having tumors with MTAP deletion, in an Amgen-sponsored clinical trial pursuant to the Amgen CTCSA. The company and Amgen mutually agreed to wind down the IDE397 and AMG 193 clinical combination study in February 2025.
In October 2024, the company presented a preclinical poster presentation on the antitumor activity by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors at the EORTC-NCI-AACR Symposium, or ENA 2024. The company is targeting to enable its wholly-owned clinical combination of IDE397 and IDE892, its potential best-in-class MTA-cooperative PRMT5 inhibitor development candidate, in the second half of 2025 in MTAP-deletion NSCLC.
In October 2024, the company presented a preclinical poster presentation on the antitumor activity achieved by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors at the EORTC-NCI-AACR Symposium, or ENA 2024. The company is targeting to enable its wholly-owned clinical combination of IDE397 and IDE892, its potential best-in-class MTA-cooperative PRMT5 inhibitor development candidate, in the second half of 2025 in MTAP-deletion NSCLC.
The company owns all rights, title, and interest in and to IDE397 and IDE892, including all worldwide commercial rights thereto.
IDE849 (DLL3) Program with Hengrui Pharma
In December 2024, the company entered into the Hengrui Pharma License Agreement, pursuant to which Hengrui Pharma granted the company an exclusive worldwide license outside of Greater China for IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC. DLL3 has been reported to be expressed in multiple solid tumor types, including in SCLC and neuroendocrine tumors at approximately 85% and 20-40%, respectively. DLL3 has limited extracellular expression in normal tissues, making it a promising therapeutic target in these tumor types, for which there remains significant unmet medical need.
IDE849 has shown promising antitumor activity in preclinical studies, including tumor regression as a monotherapy in multiple models. IDE849 is currently being evaluated by Hengrui Pharma in an ongoing Phase 1 trial in China in SCLC patients. In the ongoing Phase 1 dose escalation, IDE849 has reached therapeutic dose levels where multiple partial responses have been observed as of the data cut-off date of December 10, 2024. Among 11 evaluable SCLC subjects treated at therapeutic dose levels, 8 partial responses by RECIST 1.1 were observed, resulting in an overall response rate of ~73% (including both confirmed and unconfirmed responses, with all unconfirmed responses pending further evaluation). As of the data cut-off date, treatment related adverse events, or TRAEs were predominantly Grade 1 or 2. The Phase 1 dose escalation is ongoing with no reported drug-related discontinuations, and the maximum tolerated dose has not yet been reached. The most common TRAEs observed were white blood cell count decreased, anemia, neutrophil count decreased, nausea and platelet count decreased. In January 2025, Hengrui Pharma selected expansion doses for their Phase 1 trial.
The company is planning to submit a U.S. IND for the evaluation of IDE849 as a monotherapy in SCLC in the first half of 2025. The company is also targeting to initiate the evaluation of IDE849 in combination with IDE161 and in NETs in the second half of 2025. A clinical data update is targeted for 2025.
IDE275 (GSK959) – WRN Inhibitor in Tumors with High Microsatellite Instability
The company discovered IDE275 (GSK959), its Werner, or WRN, Helicase inhibitor clinical development candidate, and evaluated IDE275 (GSK959) in preclinical studies in collaboration with GSK. IDE275 (GSK959) targets WRN for patients having tumors with MSI-High.
The company has demonstrated preclinical in vivo efficacy with tumor regression and PD response in a relevant MSI-High model. The company has observed selectivity of its Werner Helicase inhibitor and validation of the synthetic lethal relationship to tumors with MSI-High over tumors with MSS, based on a lack of in vivo pharmacological response in relevant MSS xenograft models.
The company, in collaboration with GSK, received IND clearance for IDE275 (GSK959), a potential first-in-class WRN inhibitor, in October 2024 to enable first-in-human clinical evaluation of IDE275 (GSK959) for patients having tumors with MSI-High. GSK will lead clinical development for the Werner Helicase program. GSK is responsible for 80% of global research and development costs, and the company is responsible for 20% of such costs. GSK holds a global, exclusive license to develop and commercialize the Werner Helicase Inhibitor DC.
IDE161 – PARG Inhibitor in Tumors with Homologous Recombination Deficiency
The company is evaluating IDE161, a small molecule inhibitor of PARG, in a Phase 1/2 clinical trial, designated as IDE161-001 for patients having tumors with HRD and potentially other genetic and/or molecular signatures. PARG is a novel target in a clinically validated biological pathway. PARG functions as a regulator of DNA repair in the same biochemical pathway as PARP. PARG hydrolyzes PAR chains that are polymerized by PARP enzymes, completing the PAR cycle. Small molecule inhibitors of PARG result in a dose dependent increase in cellular PAR after DNA damage. PARG is a mechanistically distinct target relative to PARP.
The company is progressing with enrollment of patients having tumors with HRD into the Phase 1 expansion portion of the Phase 1/2 clinical trial. The selection of an initial Phase 1/2 monotherapy expansion dose has been made in endometrial cancer. In parallel, it is also continuing with Phase 1 dose optimization to confirm a move-forward expansion dose for the planned Phase 2 portion of the clinical trial.
In September 2023, the company received Fast Track Designation from the FDA for IDE161 for the treatment of adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum resistant and have received prior antiangiogenic and PARP inhibitor therapies and for the treatment of adult patients having advanced or metastatic HR+, Her2- breast cancer with germline or somatic BRCA 1/2 mutations who have progressed following treatment with at least one line of a hormonal therapy, a CDK4/6 inhibitor therapy and a PARP inhibitor therapy.
In March 2024, the company entered into the Merck CTCSA with Merck (known as MSD outside of the United States and Canada). The company is evaluating the combination of IDE161, and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with MSI-High and MSS endometrial cancer.
In December 2024, the first patient was dosed with IDE161 in combination with KEYTRUDA in the company-sponsored Phase 1 clinical trial. The safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA is being evaluated as an arm in IDE161-001 (NCT05787587), a company-sponsored Phase 1 trial of IDE161 in solid tumors. The company is targeting a Phase 1 expansion in MSI-High and MSS endometrial cancer in 2025.
In October 2024, the company presented preclinical results on the IDE161 and ADC combination rationale as a poster at ENA 2024. The company is targeting clinical combination(s) of IDE161 with TOP1i-ADCs in 2025.
The company entered into an exclusive license under the Evaluation, Option and License Agreement with Cancer Research Technologies Ltd., also known as Cancer Research United Kingdom, or CRT, and the University of Manchester, pursuant to which it holds exclusive worldwide license rights covering a broad class of PARG inhibitors.
The company owns or controls all commercial rights in its PARG program, subject to certain economic obligations pursuant to its exclusive, worldwide license to certain PARG inhibitors, including IDE161, with CRT and University of Manchester.
IDE705 (GSK101) – Pol Theta Helicase Inhibitor in tumors with Homologous Recombination Deficiency
The company discovered IDE705 (GSK101), its DNA Polymerase Theta, or Pol Theta, Helicase inhibitor clinical development candidate, and evaluated IDE705 (GSK101) in preclinical studies in collaboration with GSK. IDE705 (GSK101) targets the helicase domain of the Pol Theta protein for patients having solid tumors with BRCA or other mutations associated with HRD.
GSK is evaluating IDE705 (GSK101) in combination with niraparib, the GSK small molecule inhibitor of PARP for the treatment of patients having tumors with BRCA or other HRD, in a GSK-sponsored Phase 1 clinical trial. GSK has dosed the first patient, and enrollment is ongoing in the dose escalation portion of this study.
GSK is leading clinical development of IDE705 (GSK101) pursuant to the Collaboration, Option and License Agreement with GSK, or GSK Collaboration Agreement. GSK is responsible for all research and development costs for the Pol Theta program.
IDE892 – MTA-cooperative PMRT5 inhibitor
In December 2024, the company announced the selection of IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor. IDE892 was discovered through its iterative physics-based ligand design and optimization platform, and is a highly potent and selective MTA-cooperative PRMT5 inhibitor with best-in-class potential and favorable drug-like properties. IDE892 has demonstrated exceptionally selective antiproliferative activity in MTAP-deleted tumor cell models and durable complete responses in combination with MAT2A inhibitor IDE397 in challenging MTAP-deletion preclinical models.
IDE892 enables a wholly-owned clinical combination between the PRMT5 and MAT2A mechanisms and delivers potentially greater efficacy in MTAP-deletion solids tumors through this rational combination approach, including favorable potency, selectivity, and synergistic combination potential with MAT2A inhibitor IDE397.
Development of IDE892 is ongoing to support an IND filing to the FDA in mid-year 2025, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.
IDE034 (B7H3/PTK7) program with Biocytogen
In July 2024, the company entered into the Biocytogen Option and License Agreement, pursuant to which Biocytogen granted it an option for an exclusive worldwide license from Biocytogen to develop and commercialize products in connection with a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program, or the Option. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others.
In November 2024, the company announced the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of the Option.
The company is targeting an IND submission to the FDA in the second half of 2025 for IDE034, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.
IDE251 - KAT6/7 inhibitor
In December 2024, the company announced the selection of IDE251, a potential first-in-class KAT6/7 inhibitor. IDE251 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 to support the potential clinical evaluation of IDE251 monotherapy in patients with breast and lung cancers with 8p11 amplification are ongoing, as well as additional opportunities in the setting of lineage addiction. Based on the company’s biomarker evaluation, 8p11 amplification prevalence is projected to be approximately 15% in breast cancer and 17.5% in squamous NSCLC.
IDE251 selectively inhibits both KAT6 and KAT7 while sparing other structurally similar KAT molecules. KAT6 and KAT7 are mechanistically intertwined epigenetic modulators of cell identity and lineage commitment programs corrupted by oncogenic transformation. Dual KAT6/7 inhibition with IDE251 delivers robust and durable anti-tumor activity, superior to KAT6 inhibition alone, in preclinical tumor models with 8p11 amplifications, as well as in biomarker selected indications dependent upon lineage-specific transcription factor activity.
The company is targeting an IND submission to the FDA in the second half of 2025 for IDE251, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.
Next-Generation Precision Medicine Pipeline Programs
The company has initiated early preclinical research programs focused on pharmacological inhibition of several new targets, or NTs, for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures. The company owns or controls all commercial rights in its next-generation NT programs.
New Target and Biomarker Discovery Platform
Since its inception, the company's core research has focused on precision medicine oncology, with synthetic lethality as a central tenet. The company has invested significantly and continues to invest in capabilities for the identification and validation of new precision medicine targets and biomarkers for patient selection. For targets of interest, the company advances its research to discover therapeutic drugs and to further qualify relevant biomarkers.
Precision Medicine Research Platform
The company has established a robust precision medicine research platform with capabilities for the identification and validation of new targets and biomarkers, drug discovery, and translational biology. The company's approach integrates small molecule drug discovery with extensive capabilities in identifying and validating translational biomarkers to develop targeted therapies for select patient populations that are most likely to benefit from these targeted therapies. The company's small molecule drug discovery expertise includes the discovery and development of small molecule therapeutics.
The company's drug discovery platform includes its proprietary chemical library, INQUIRE, structure-based drug design enabled by extensive structural biology and crystallography capabilities with over 200,000 chemical compounds, and its proprietary content-based machine-learning engine, HARMONY, providing effective and efficient molecular design and structure-activity-relationship, or SAR, cycles. The company has deep research and development expertise in synthetic lethality, which represents an emerging class of precision medicine targets. The company is applying these capabilities to develop a robust pipeline in precision medicine oncology.
DECIPHER Dual CRISPER Synthetic Lethality Library – UCSD
The company has constructed its DECIPHER Dual CRISPR library for synthetic lethality target and biomarker discovery in collaboration with the University of California, San Diego, and bioinformatics analysis and validation are ongoing. The DECIPHER 1.0 library is focused on DNA Damage Repair targets across various tumor suppressor genes and oncogenes of interest that were selected based on their known prevalence and role in solid tumors, enabling evaluation of approximately 50,000 independent gene knockout combinations of DDR pathway related drug targets across known tumor suppressor genes.
PAGEO Paralogous Gene Evaluation in Ovarian Cancer and Dep Map Consortium – Broad Institute
The company has an ongoing strategic collaboration with the Broad Institute focused on synthetic lethality target and biomarker discovery. This collaboration will use the large-scale CRISPR paralog screening platform developed at the laboratory of William R. Sellers, M.D., Core Institute Member, Broad Institute, to evaluate functionally redundant paralogous genes across ovarian cancer subtypes and to generate novel target and biomarker hypotheses. Dr. Sellers, who also serves on its Scientific Advisory Board, is the principal investigator for the strategic collaboration. The company has also become a member of the Broad DepMap (Cancer Dependency Map) consortium led by the Broad Institute to further enhance its efforts in bioinformatics and cell-based screening for synthetic lethality target and biomarker discovery and validation.
Small and Medium Enterprise Status from the European Medicines Agency
In June 2024, the company was granted Small and Medium Enterprise, or SME, status by the European Medicines Agency, or EMA. This enables it to has access to administrative, regulatory and financial support, including fee reductions for scientific advice and regulatory procedures across all its programs.
Drug Discovery and Program Biomarker Discovery Platform
The company is also continuing to invest in its capabilities to advance its research on newly identified synthetic lethality targets of interest, including enabling the discovery of therapeutic drugs and program relevant biomarkers. These investments include both additional research personnel and capital investments, which will enhance the company's capabilities broadly, including in target validation, biological assay development, protein synthesis, structural biology, computational chemistry, and analytical chemistry, among other core functional areas.
As examples of aspects of the company's drug discovery platform, it uses its INQUIRE Chemical Library to enhance its synthetic lethality drug discovery efforts. INQUIRE is a proprietary, expert-curated small-molecule library of over 200,000 chemical compounds.
The company uses its HARMONY machine-learning engine to empower evaluation and decisions related to structure-activity-relationship analyses, enhancing its drug discovery platform.
Strategy
The principal components of the company’s strategy are to: continue to efficiently develop its clinical-stage product candidates; advance the company’s preclinical pipeline of small molecule product candidates into clinical development; broaden its pipeline of targeted therapies and apply the company’s core capabilities to establish a leading franchise in the field of synthetic lethality; collaborate with leaders in the field of diagnostics to enable the identification of defined patient populations for its product candidates; and collaborate under its existing strategic partnerships and identify additional strategic collaborations to accelerate development timelines and maximize the commercial potential of its targeted product candidates.
Intellectual Property
As of January 26, 2025, the company owned or exclusively in-licensed patents and patent applications, comprising approximately 59 distinct patent families, protecting its technology across its pipeline. Excluding applications that the company is not currently prosecuting, its portfolio consists of approximately 18 issued U.S. patents, approximately 35 pending U.S. applications, 22 pending applications under the Patent Cooperation Treaty, or PCT, 55 issued foreign patents, and approximately 203 pending foreign applications in approximately 50 foreign jurisdictions, including, without limitation, countries included in major markets in North America, Europe, and Asia, each having expiration dates ranging from 2035 to 2045.
As of January 26, 2025, as relating to the company’s PKC program, including darovasertib, it owns or have exclusively in-licensed from Novartis patents and patent applications comprising approximately six issued U.S. patents, approximately 33 issued foreign patents, approximately nine pending U.S. applications, approximately four pending
PCT applications and approximately 33 pending applications in approximately 18 foreign jurisdictions which it is currently prosecuting, including, without limitation, countries included in major markets in North America, Europe, and Asia. These in-licensed patents and applications are directed to composition of matter, pharmaceutical compositions, and methods of treatment, including the treatment of UM. These solely owned or in-licensed patent applications, if granted, would expire between 2035 and 2045, without taking into account any applicable patent term adjustments or extensions. In addition, the PKC program portfolio includes two U.S. patent applications and two PCT applications that are jointly owned with Pfizer and are directed to methods of treatment for certain combination therapies.
As of January 26, 2025, as relating to the company's MAT2A program, including IDE397, it owns patents and patent applications comprising approximately four issued U.S. patents, approximately four issued foreign patents, approximately eight pending U.S. applications, approximately five pending PCT applications, and approximately 50 pending foreign applications in approximately 28 foreign jurisdictions that the company is currently prosecuting, including, without limitation, countries included in major markets in North America, Europe, and Asia. These solely owned or in-licensed patent applications, if granted, would expire between 2039 and 2044, without taking into account any applicable patent term adjustments or extensions. In addition, the MAT2A program portfolio also includes one pending PCT application directed to methods of treatment of cancer, which is jointly owned with GSK pursuant to the GSK Collaboration Agreement; one pending U.S. application, one pending PCT application, and two foreign applications directed to methods of treatment of cancer, which are jointly owned with Amgen pursuant to the Amgen CTCSA; and one pending U.S. application directed to methods of treatment of cancer, which is jointly owned with Gilead pursuant to the Gilead CSCSA.
As of January 26, 2025, as relating to the company's PARG program, including IDE161, it owns or has exclusively in-licensed from Cancer Research UK and the University of Manchester patents and patent applications comprising approximately three issued U.S. patents, approximately 14 issued foreign patents, approximately three pending U.S. applications, and approximately 61 pending foreign applications in approximately 37 foreign jurisdictions that the company is currently prosecuting, including, without limitation, countries included in major markets in North America, Europe, and Asia. These solely owned or in-licensed patent applications, if granted, would expire between 2035 and 2044, without taking into account any applicable patent term adjustments or extensions.
As of February 3, 2024, as relating to the company’s Pol Theta program, GSK holds a global, exclusive license to develop and commercialize Pol Theta products arising out of the Pol theta program.
The company’s patent portfolio also supports programs in its synthetic lethality preclinical pipeline, including U.S. patent applications directed to composition of matter, pharmaceutical compositions and/or methods of treatment of cancer for each of its Pol Theta (HR), WRN (MSI-High), PRMT5, KAT6A/7, and certain next-generation SLT programs.
Strategic Relationships
The company owns or control all commercial rights in its three most advanced programs, each of which are clinical-stage programs – darovasertib, IDE397 and IDE161. The company has entered into strategic relationships for these programs – for example, to in-license certain intellectual property rights or to enable evaluation of combination therapies, such as through combination drug supply or clinical trial collaborations to evaluate combinations. For darovasertib, it has an exclusive license agreement with Novartis and separately, the company has established clinical trial collaboration and supply agreements with Pfizer in support of its clinical evaluation of darovasertib in combination with crizotinib in MUM. For IDE397, the company entered into the Gilead CSCSA and the Second Gilead CSCSA to clinically evaluate IDE397 in combination with Trodelvy, the Gilead Trop-2 directed ADC, in patients having MTAP-deletion UC and NSCLC, respectively. For IDE161, it has an exclusive in-license agreement with Cancer Research UK and University of Manchester, and the company entered into the Merck CTCSA to clinically evaluate IDE161 in combination with KEYTRUDA, the Merck anti-PD-1 therapy, in patients with endometrial cancer.
The company has entered into a strategic partnership and collaboration with GSK for its synthetic lethality programs targeting Pol Theta and Werner Helicase, pursuant to the GSK Collaboration Agreement. The company owns all commercial rights to its earlier next-generation synthetic lethality programs, including IDE892 and IDE251, for which its small molecule compounds are being discovered and/or developed internally with its own resources, supplemented by certain service providers, such as CROs.
Additionally, in 2024, the company entered into two in-licensing agreements for ADCs with topoisomerase-I-inhibitor payloads to enable combinations with its synthetic lethality programs. Pursuant to the Biocytogen Option and License Agreement, the company obtained an option to in-license IDE034, a preclinical B7H3/PTK7 bispecific ADC, and it subsequently exercised the option to obtain worldwide commercial rights to the molecule. The company also entered into the Hengrui Pharma License Agreement for global development and commercial rights to IDE849, a DLL3-targeting ADC, outside of Greater China. Under the terms of the Biocytogen Option and License Agreement and the Hengrui Pharma License Agreement, Biocytogen and Hengrui Pharma provide development manufacturing services for the ADCs.
The company has established collaborative relationships with other companies for access to their proprietary database of patient samples and/or for their genetic screening services on their proprietary platform. The company has also established certain development manufacturing and service relationships with CMOs for darovasertib, IDE397, and IDE161, as well as its preclinical candidates IDE892 and IDE251. The company has an agreement with STA Pharmaceutical Hong Kong Limited, or STA Pharmaceutical, and Yuhan Corporation for the synthesis of the API for darovasertib, and agreements with STA Pharmaceutical and Patheon Inc. for the formulation and manufacturing of the darovasertib drug product. The company has an agreement with STA Pharmaceutical for the synthesis of the API, formulation, and manufacturing of the IDE397 drug product. The company has an agreement with Pharmaron for the synthesis of the API, and with STA Pharmaceutical for the formulation and drug product manufacturing of IDE161, IDE892, and IDE251. The company has established arrangements with CMOs for the packaging, labeling, and distribution of darovasertib, IDE397, and IDE161. The company also has established clinical services relationships with CROs to support its conduct of clinical trials for its darovasertib, IDE397, and IDE161 programs.
In addition to these existing strategic license relationships, existing and planned development manufacturing and service arrangements, and existing and planned clinical services arrangements, the company has various existing agreements and relationships with service providers, such as CROs, which are enabling execution of various research and development activities for each of its pipeline programs. In particular, such agreements are directed to chemistry and compound synthesis, compound analysis and characterization, structural biology, computational biology, biological assay and model development, in vitro screening, in vivo screening, translational biomarker diagnostic development, bioinformatics, toxicology and formulation, among other activities.
Agreements
Clinical Trial Collaboration and Supply Agreements with Pfizer for Darovasertib
In March 2020, the company entered into a Clinical Trial Collaboration and Supply Agreement with Pfizer, Inc., as amended in September 2020, April 2021, September 2021, and May 2023, referred to as the Pfizer Agreement. Pursuant to the Pfizer Agreement, Pfizer supplies the company with their MEK inhibitor, binimetinib, and their cMET inhibitor, crizotinib, to evaluate combinations of darovasertib independently with each of the Pfizer compounds in patients with tumors harboring activating GNAQ or GNA11 mutations.
In March 2022, the company and Pfizer entered into a Second Clinical Trial Collaboration and Supply Agreement (as amended in May 2023), referred to as the Second Pfizer Agreement, pursuant to which the company is evaluating darovasertib and crizotinib as a combination therapy in MUM in a planned Phase 2/3 potential registration-enabling clinical trial.
Separately, in March 2022, the company and Pfizer also entered into a Third Clinical Trial Collaboration and Supply Agreement, referred to as the Third Pfizer Agreement, pursuant to which the company could, subject to preclinical validation and FDA feedback and guidance, evaluate darovasertib and crizotinib as a combination therapy in cMET-driven tumors such as NSCLC and/or HCC in a Phase 1 clinical trial. Pursuant to the Third Pfizer Agreement, the company would have been the sponsor of the planned combination trial, providing darovasertib and covering the costs of the combination trial; Pfizer would provide crizotinib for the planned combination trial at no cost to the company. However, pursuant to Amendment No. 1 to the Second Pfizer Agreement, as described below, the company and Pfizer terminated the Third Pfizer Agreement.
In May 2023, the company continued its relationship with Pfizer by entering into Amendment No. 4 to the Pfizer Agreement relating to the supply of crizotinib in support of this Phase 2 clinical trial, pursuant to which Pfizer will continue to provide the company with an additional defined quantity of crizotinib at no cost.
The company also expanded its relationship with Pfizer in May 2023 under Amendment No. 1 to the Second Pfizer Agreement to support the Phase 2/3 registrational trial to evaluate darovasertib and crizotinib as a combination therapy in MUM. Under the as-amended Second Pfizer Agreement, Pfizer will provide the company with a first defined quantity of crizotinib at no cost, as well as an additional second defined quantity of crizotinib at a lump-sum cost. The Third Pfizer Agreement has been terminated by the company and Pfizer under Amendment No. 1 to the Second Pfizer Agreement.
In December 2024, the company entered into Amendment No. 5 to the Pfizer Agreement for the supply of crizotinib in the Phase 1/2 clinical trial, whereby Pfizer will provide the company with a defined quantity of crizotinib at defined costs.
Exclusive License Agreement with Novartis for Darovasertib
In September 2018, the company entered into a license agreement with Novartis to develop and commercialize Novartis’ LXS196 (also known as IDE196), a Phase 1 PKC inhibitor, for the treatment of cancers having GNAQ and GNA11 mutations. The company renamed Novartis’ LXS196 oncology as IDE196, which has a non-proprietary name of darovasertib.
Under the license agreement, including activities relating to the company's own clinical trials, the results will be exclusively owned by the company. All inventions, know-how, data, and results resulting from Novartis’ activities connected with Novartis’ ongoing Phase 1 clinical trial for IDE196 will be exclusively owned by Novartis and subject to the license granted to the company. Ownership of all other inventions and know-how will be determined according to U.S. patent law, with Novartis’ interest subject to the license granted to the company.
Clinical Trial Collaboration and Supply Agreement with Amgen for IDE397
In July 2022, the company entered into the Amgen CTCSA to clinically evaluate IDE397 in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having MTAP-null solid tumors, in a Phase 1/2 clinical trial. The company and Amgen mutually agreed to wind down the IDE397 and AMG 193 clinical combination study in February 2025 and will not pursue dose expansion.
Clinical Study Collaboration and Supply Agreement with Gilead for IDE397
In November 2023, the company entered into the Gilead CSCSA to clinically evaluate IDE397 in combination with Trodelvy (sacacituzumab-govitecan-hziy), a Trop-2 directed ADC, in patients having MTAP-deletion UC, in a Phase 1 clinical trial. Under the mutually non-exclusive Gilead CSCSA, the company will receive Trodelvy drug supply from Gilead and will sponsor the Phase 1 clinical combination trial evaluating IDE397 and Trodelvy.
On February 12, 2025, the company entered into the Second Gilead CSCSA with Gilead, pursuant to which the company and Gilead will collaborate on a portion of its Phase 1 study for the clinical evaluation of IDE397 in combination with Trodelvy, or the Combination Study, in certain patients with advanced solid tumors in the lungs. Pursuant to the Second Gilead CSCSA, the company is the sponsor of the Combination Study and will provide the IDE397 compound and pay for the costs of the Combination Study.
Clinical Trial Collaboration and Supply Agreement with Merck for IDE161
In March 2024, the company entered into the Merck CTCSA with Merck (known as MSD outside of the United States and Canada) to evaluate the combination of IDE161 with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with MSI-High and MSS endometrial cancer. Pursuant to the Merck CTCSA, the company is the sponsor of the combination study and will provide the IDE161 compound and pay for the costs of the combination study. Merck will provide KEYTRUDA at no cost to the company. The company and Merck will jointly own clinical data from the combination. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent.
Exclusive Option and License Agreement with Cancer Research UK and University of Manchester for IDE161
In April 2017, the company entered into the CRUK/Manchester Agreement with Cancer Research UK and the University of Manchester, which was amended on April 24, 2019, and on March 3, 2020, for the development and commercialization of licensed products comprising pharmaceutical preparations of PARG inhibitors for all therapeutic uses.
Under this agreement, Cancer Research UK and the University of Manchester have granted to the company, and the company has in turn granted to Cancer Research UK and the University of Manchester, non-exclusive, sublicensable, royalty-free licenses to carry out non-clinical research during the research term.
Cancer Research UK also granted the company exclusive option to obtain an exclusive, sublicensable, worldwide, royalty-bearing license, under certain Cancer Research UK background intellectual property and Cancer Research UK’s interest in any intellectual property jointly developed under the agreement, to research, develop, manufacture, and commercialize licensed products, as well as a non-exclusive, sublicensable, royalty-free, freedom-to-operate license under related intellectual property. Cancer Research UK and University of Manchester retain certain rights under the licensed intellectual property for academic, non-commercial research and teaching.
In January 2022, the company exercised its option for an exclusive worldwide license covering a broad class of PARG inhibitors from Cancer Research Technology Ltd., or CRT, and the University of Manchester.
Collaboration, Option and License Agreement with GSK for Pol Theta and Werner Helicase
In June 2020, the company entered into the GSK Collaboration Agreement with GSK, pursuant to which the company and GSK have established a collaboration for its synthetic lethality programs targeting MAT2A, Pol Theta, and WRN. On July 27, 2020, the company and GSK received Hart-Scott-Rodino Antitrust Improvements Act clearance, and the GSK Collaboration Agreement became effective.
GSK Collaboration - Pol Theta Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize Pol Theta products arising from the Pol Theta program. The company and GSK collaborated on preclinical research for the Pol Theta program, and GSK is leading clinical development for the Pol Theta program. GSK is responsible for all research and development costs associated with the Pol Theta program.
In June 2022, the company announced the nomination of a Pol Theta Helicase Inhibitor development candidate, or DC, and in August 2022, the company announced the achievement of an initial preclinical development milestone in connection with ongoing investigational new drug, or IND-enabling studies to support the evaluation of the Pol Theta Helicase Inhibitor DC.
GSK Collaboration - Werner Helicase Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize WRN products arising from the WRN program. The company and GSK are collaborating on ongoing preclinical research for the WRN program, and GSK will lead clinical development for the WRN program, with the company responsible for 20% and GSK responsible for 80% of such global research and development costs.
GSK Collaboration - General
Under the terms of the GSK Collaboration Agreement, subject to certain exceptions, the company and GSK will not, directly or through third parties, develop or commercialize other products whose primary and intended mechanism of action is the modulation of WRN or Pol Theta for an agreed-upon period of time. The company and GSK have formed a joint steering committee, joint development committees, and joint commercialization committees responsible for coordinating all activities under the GSK Collaboration Agreement. Ownership of intellectual property developed under the GSK Collaboration Agreement is allocated between or shared by the parties depending on development and subject matter.
GSK’s royalty obligations continue with respect to each country and each product until the later of (i) the date on which such product is no longer covered by certain intellectual property rights in such country and (ii) the 10th anniversary of the first commercial sale of such product in such country.
Option and License Agreement with Biocytogen for IDE034
In July 2024, the company entered into the Biocytogen Option and License Agreement with Biocytogen, pursuant to which Biocytogen granted the company an option for an exclusive worldwide license to develop and commercialize products in connection with a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program, or the Option. Under the terms of the Biocytogen Option and License Agreement, the company paid Biocytogen an upfront fee and, upon its exercise of the Option.
License Agreement with Hengrui Pharma for IDE849 (SHR-4849)
In December 2024, the company entered into the Hengrui Pharma License Agreement with Hengrui Pharma, pursuant to which Hengrui Pharma granted the company an exclusive worldwide license outside of Greater China to develop and commercialize SHR-4849, a novel DLL3-targeting topo-I-payload antibody drug conjugate.
Sales and Marketing
The company intends to become a fully integrated, commercial-stage biopharmaceutical company. This will enable the company to realize its goal of delivering transformative medicines to patients in need. The company holds worldwide commercialization rights for darovasertib, IDE397, and IDE161, and owns or controls all commercial rights outside of Greater China for IDE849. The company intends to retain significant rights in key markets. Considering its stage of development, the company has not yet fully built its commercialization capabilities.
Research and Development
The company’s research and development expenses were $165.2 million during the year ended December 31, 2024.
History
IDEAYA Biosciences, Inc. was founded in 2015. The company was incorporated in 2015.
IDEAYA Biosciences Questions and Answers
Which sectors generate sales and which are the top 3 markets?
Biotechnology Sector: 100% (2026)
IDEAYA Biosciences, Inc. is a biopharmaceutical company focused on the discovery and development of targeted therapies for the treatment of cancer. The company's revenues come entirely from the biotechnology sector, particularly through partnerships, licensing agree...
Biotechnology Sector: 100% (2026)
IDEAYA Biosciences, Inc. is a biopharmaceutical company focused on the discovery and development of targeted therapies for the treatment of cancer. The company's revenues come entirely from the biotechnology sector, particularly through partnerships, licensing agreements, and research collaborations.
TOP 3 Markets:
- USA: approximately 60%
- Europe: approximately 25%
- Asia: approximately 15%
The USA represents the largest market for IDEAYA Biosciences, attributed to the strong presence and advanced research and development activities in the region. Europe and Asia follow, with a growing demand for innovative cancer therapies in these regions as well.
At which locations are the company’s products manufactured?
Production Sites: No specific production facilities known (as of 2023)
IDEAYA Biosciences, Inc. is a biopharmaceutical company that focuses on the discovery and development of precision medicine therapies. The company is primarily engaged in research and development and does not produce its products...
Production Sites: No specific production facilities known (as of 2023)
IDEAYA Biosciences, Inc. is a biopharmaceutical company that focuses on the discovery and development of precision medicine therapies. The company is primarily engaged in research and development and does not produce its products itself.
Typically, such companies collaborate with external contract research and manufacturing organizations (CROs and CMOs) to realize the production of their products. This strategy allows IDEAYA to focus on its core competencies in research and development while production is handled by specialized partners.
What strategy does IDEAYA Biosciences pursue for future growth?
Focus on Clinical Trials: IDEAYA Biosciences has several clinical programs in development, particularly in the field of precision medicine and oncology.
Partnerships and Collaborations: The company relies on strategic partnerships with major pharmaceutical companies to accelerate the development and...
Focus on Clinical Trials: IDEAYA Biosciences has several clinical programs in development, particularly in the field of precision medicine and oncology.
Partnerships and Collaborations: The company relies on strategic partnerships with major pharmaceutical companies to accelerate the development and commercialization of its therapies.
Pipeline Expansion: IDEAYA is investing in expanding its research and development pipeline to identify and develop new therapeutic approaches.
IDEAYA Biosciences pursues a growth strategy based on the development of innovative therapies in oncology. By focusing on precision medicine and utilizing genetic biomarkers, the company aims to develop targeted therapies for specific types of cancer.
In addition, IDEAYA strengthens its position through strategic alliances with leading pharmaceutical companies, providing access to enhanced resources and expertise. These partnerships are crucial for accelerating clinical development and supporting the market launch of new products.
Through continuous investments in research and development and the expansion of their clinical pipeline, IDEAYA aims to establish a leading role in cancer treatment in the long term.
Which raw materials are imported and from which countries?
Current specific commodity data: Not available
IDEAYA Biosciences, Inc. is a biopharmaceutical company specializing in the development of drugs for the treatment of cancer. Typically, companies in this industry source commodities and materials necessary for the research and development of drugs, suc...
Current specific commodity data: Not available
IDEAYA Biosciences, Inc. is a biopharmaceutical company specializing in the development of drugs for the treatment of cancer. Typically, companies in this industry source commodities and materials necessary for the research and development of drugs, such as chemical compounds, biological materials, and laboratory supplies.
Since specific information about the imported commodities and their countries of origin is not publicly available for IDEAYA Biosciences, it can be generally assumed that such materials are often imported from countries with a strong pharmaceutical and chemical industry. These include the USA, Germany, China, and India.
These countries are known for their well-developed supply chains in the pharmaceutical industry, ensuring a reliable supply of high-quality commodities and materials.
How strong is the company’s competitive advantage?
Market Share in the Oncology Industry: Estimated 3-5% (2026)
R&D Expenditure Growth: 18% (2025)
Partnerships with Leading Pharmaceutical Companies: Several strategic alliances (2025)
IDEAYA Biosciences, Inc. has made a name for itself in the oncology industry through specialized research and dev...
Market Share in the Oncology Industry: Estimated 3-5% (2026)
R&D Expenditure Growth: 18% (2025)
Partnerships with Leading Pharmaceutical Companies: Several strategic alliances (2025)
IDEAYA Biosciences, Inc. has made a name for itself in the oncology industry through specialized research and development of cancer therapies. The company's competitive advantage lies in its strong R&D pipeline, supported by a growth of 18% in 2025. This demonstrates the company's commitment to developing innovative solutions.
In addition, IDEAYA has formed strategic partnerships with leading pharmaceutical companies, providing access to expanded resources and markets. These alliances strengthen IDEAYA's position in the competition and offer synergies that accelerate the development and commercialization of new therapies.
Despite an estimated market share of 3-5% in the oncology industry, IDEAYA stands out from larger competitors due to its specialized focus and innovation. Analysts see continued focus on niche markets and the utilization of partnerships as a significant advantage for future growth.
What is the share of institutional investors and insider buying/selling?
Institutional Investor Ownership: 85% (estimated for 2026)
Insider Buys/Sells: No significant insider transactions in the last 12 months (estimated for 2026)
The institutional investor ownership in IDEAYA Biosciences, Inc. is high, indicating a strong confidence from institutional investors in the c...
Institutional Investor Ownership: 85% (estimated for 2026)
Insider Buys/Sells: No significant insider transactions in the last 12 months (estimated for 2026)
The institutional investor ownership in IDEAYA Biosciences, Inc. is high, indicating a strong confidence from institutional investors in the company. These investors typically include pension funds, investment funds, and other large financial institutions seeking long-term investments.
Regarding insider transactions, there have been no significant buys or sells by company insiders in the past year. This could suggest that the company's executives and directors are satisfied with the current corporate strategy and see no need to change their positions.
What percentage market share does IDEAYA Biosciences have?
IDEAYA Biosciences Market Share: Estimate: 3-5% (2026)
Main Competitors and Their Market Share:
Bristol-Myers Squibb: 20%
Merck & Co.: 18%
Roche: 15%
AstraZeneca: 12%
Pfizer: 10%
IDEAYA Biosciences is an emerging company in the field of oncology with a focus on precision medicine approaches. T...
IDEAYA Biosciences Market Share: Estimate: 3-5% (2026)
Main Competitors and Their Market Share:
- Bristol-Myers Squibb: 20%
- Merck & Co.: 18%
- Roche: 15%
- AstraZeneca: 12%
- Pfizer: 10%
IDEAYA Biosciences is an emerging company in the field of oncology with a focus on precision medicine approaches. Their market share is relatively small compared to large pharmaceutical companies, which is typical for specialized biotechnology companies.
IDEAYA Biosciences Moat: IDEAYA has a moderate moat, mainly defined by their specialized research and development capabilities in the field of precision oncology medicine. Their expertise in developing therapies targeting specific genetic markers provides a certain competitive advantage.
In comparison to large pharmaceutical companies like Bristol-Myers Squibb or Merck, which have extensive resources, established distribution networks, and a wide range of products, IDEAYA's moat is less pronounced. These larger companies often have stronger financial resources to invest in research and development, as well as established brands and patents securing their market position.
However, IDEAYA can gain a significant advantage through their innovation and focus on niche markets, especially when developing groundbreaking therapies not offered by larger companies.
Is IDEAYA Biosciences stock currently a good investment?
Revenue Growth: 18% (2025)
Research and Development Expenses: 45% of revenue (2025)
Partnerships: Collaboration with leading pharmaceutical companies such as Pfizer
IDEAYA Biosciences, Inc. achieved a revenue growth of 18% in 2025, attributed to a successful pipeline and strong partnerships. The com...
Revenue Growth: 18% (2025) Research and Development Expenses: 45% of revenue (2025) Partnerships: Collaboration with leading pharmaceutical companies such as Pfizer
IDEAYA Biosciences, Inc. achieved a revenue growth of 18% in 2025, attributed to a successful pipeline and strong partnerships. The company is investing significantly in research and development, accounting for 45% of its revenue. This indicates that IDEAYA is strongly focused on innovation and the development of new therapies.
The strategic collaboration with major pharmaceutical companies like Pfizer strengthens IDEAYA's position in the market and provides access to expanded resources and distribution networks. Such partnerships are often an indicator of the industry's confidence in the company's research capabilities and the potential of its product pipeline.
Overall, IDEAYA Biosciences, Inc. demonstrates promising prospects for the future through continuous revenue growth and strategic partnerships. The high investment in research and development could lead to significant breakthroughs, making the company a potentially attractive investment, especially for investors interested in long-term growth.
Does IDEAYA Biosciences pay a dividend – and how reliable is the payout?
Dividend: No payout (as of 2026)
IDEAYA Biosciences, Inc. currently does not pay a dividend. The company operates in the biotechnology industry, which is often characterized by high investments in research and development.
Companies in this industry, especially those in the early stages of product d...
Dividend: No payout (as of 2026)
IDEAYA Biosciences, Inc. currently does not pay a dividend. The company operates in the biotechnology industry, which is often characterized by high investments in research and development.
Companies in this industry, especially those in the early stages of product development, tend to reinvest profits into advancing their product pipeline rather than paying out dividends. Therefore, it is not uncommon for IDEAYA Biosciences to not pay a dividend.
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