This section highlights FDA-related milestones and regulatory updates for drugs developed by IDEAYA Biosciences (IDYA).
Over the past two years, IDEAYA Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Darovasertib, Darovasertib, IDE161, IDE275, IDE397, IDE849, and IDE892. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Darovasertib - FDA Regulatory Timeline and Events
Darovasertib is a drug developed by IDEAYA Biosciences for the following indication: Non-metastatic uveal melanoma (UM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Darovasertib
- Announced Date:
- April 14, 2025
- Indication:
- Non-metastatic uveal melanoma (UM)
Announcement
IDEAYA Biosciences, Inc. announced a successful FDA Type D meeting on the Phase 3 registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma (UM).
AI Summary
IDEAYA Biosciences announced a successful FDA Type D meeting regarding the design of its Phase 3 registrational trial. This trial will assess the safety and efficacy of darovasertib as neoadjuvant therapy for primary uveal melanoma (UM). The meeting provided guidance for using key clinical endpoints to secure full regulatory approval. For the enucleation-eligible cohort, the primary endpoint will focus on eye preservation rate, while for the plaque brachytherapy cohort, it will assess the proportion of patients experiencing significant vision loss. Additionally, the trial will require that darovasertib does not adversely impact event-free survival in either cohort.
The Phase 3 trial is projected to enroll about 520 patients randomized at a 2:1 ratio, and IDEAYA aims to start enrollment in the first half of 2025. The successful meeting sets a clear path for darovasertib’s development as a critical treatment option for primary UM.
Read Announcement- Drug:
- Darovasertib
- Announced Date:
- March 31, 2025
- Indication:
- Non-metastatic uveal melanoma (UM)
Announcement
IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended.
AI Summary
IDEAYA Biosciences announced that the FDA has granted Breakthrough Therapy designation for its experimental drug darovasertib, a potential first-in-class protein kinase C inhibitor. This designation is for the neoadjuvant treatment of adult patients with primary uveal melanoma—a type of eye cancer—who are candidates for enucleation, or eye removal.
The FDA’s decision was supported by updated clinical data from a Phase 2 trial showing promising outcomes in reducing tumor size and preserving the eye. With no approved systemic therapies available for this condition, the Breakthrough Therapy designation is important because it allows for expedited development and priority review by the FDA. IDEAYA plans to present further Phase 2 results in 2025 and aims to initiate a Phase 3 registrational trial later next year, potentially offering a critical new treatment option for patients with uveal melanoma.
Read Announcement- Drug:
- Darovasertib
- Announced Date:
- September 23, 2024
- Indication:
- Non-metastatic uveal melanoma (UM)
Announcement
IDEAYA Biosciences, Inc
AI Summary
IDEAYA Biosciences, Inc. announced encouraging interim Phase 2 clinical data for darovasertib in neoadjuvant uveal melanoma (UM). The data showed that approximately 49% of patients experienced over 30% tumor shrinkage, with about 61% of enucleation-eligible patients preserving their eye. These results support the potential of darovasertib as a new treatment option for UM and set a promising stage for a Phase 3 registrational trial. This upcoming trial is expected to enroll around 400 patients from North America, Europe, and Australia, targeting both enucleation and plaque brachytherapy cohorts. In discussions with the FDA, the design of the registrational trial includes primary endpoints of eye preservation and time to vision loss, with efforts underway to consider overall response rate as a surrogate endpoint for earlier approval scenarios. The data highlights the potential to offer patients a treatment that may help preserve vision while effectively managing tumor size.
Read Announcement- Drug:
- Darovasertib
- Announced Date:
- September 22, 2024
- Estimated Event Date Range:
- September 23, 2024 - September 23, 2024
- Target Action Date:
- September 23, 2024
- Indication:
- Non-metastatic uveal melanoma (UM)
Announcement
IDEAYA Biosciences, Inc. announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM).
AI Summary
IDEAYA Biosciences announced that it will issue a pre-market press release and hold an investor webcast on Monday, September 23, 2024 at 8:00 a.m. ET. During this webcast, the company will share interim Phase 2 clinical data for darovasertib, a selective protein kinase C inhibitor being developed to target uveal melanoma (UM) in both its primary and metastatic forms.
The presentation will also include a regulatory update from an FDA Type C meeting focused on the drug’s use in neoadjuvant UM. The webcast will cover details such as registrational trial design based on FDA guidance, baseline characteristics, the adverse event profile, and clinical efficacy results. IDEAYA’s management, along with a key opinion leader, will participate in the webcast, providing insights into the latest developments surrounding darovasertib.
Read Announcement- Drug:
- Darovasertib
- Announced Date:
- June 3, 2024
- Indication:
- Non-metastatic uveal melanoma (UM)
Announcement
IDEAYA Biosciences, Inc announced updated clinical results from the ongoing investigator-sponsored Phase 2 trial of darovasertib, a first-in-class oral, small molecular inhibitor of protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (UM) and clinical update for Phase 2 company-sponsored neoadjuvant UM study.
AI Summary
IDEAYA Biosciences has shared promising clinical results from an ongoing investigator-sponsored Phase 2 trial of darovasertib—its first-in-class oral PKC inhibitor used in the neoadjuvant/adjuvant treatment of uveal melanoma (UM). In this study, 75% of the 12 enucleation patients achieved eye preservation, and 67% showed over 30% tumor shrinkage, with a median shrinkage of 47% by volume after six months of treatment.
The company also provided an update on its Phase 2 neoadjuvant UM study, which has enrolled over 40 patients. Among the eight patients treated for at least four months, a median tumor shrinkage of 72% by volume was observed, with most patients avoiding enucleation by being converted to plaque brachytherapy or external beam radiotherapy. IDEAYA plans a Type C meeting with the FDA in H2 2024 to discuss a potential registrational trial for darovasertib in this setting.
Read Announcement
Darovasertib + Crizotinib - FDA Regulatory Timeline and Events
Darovasertib + Crizotinib is a drug developed by IDEAYA Biosciences for the following indication: Metastatic uveal melanoma (MUM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Darovasertib + Crizotinib
- Announced Date:
- December 17, 2024
- Indication:
- Metastatic uveal melanoma (MUM)
Announcement
IDEAYA Biosciences, Inc announced the Independent Data Monitoring Committee (IDMC) recommendation of a move-forward dose and the completion of the Part 2a dose optimization consistent with the U.S. Food and Drug Administration's (FDA) Project Optimus guidelines for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line (1L) setting in patients with HLA-A2-negative (HLA-A2(-)) metastatic uveal melanoma (MUM).
AI Summary
IDEAYA Biosciences announced that its Independent Data Monitoring Committee (IDMC) has recommended a move-forward dose and confirmed the completion of the Part 2a dose optimization for its registration-enabling Phase 2/3 trial. This trial, conducted according to the FDA’s Project Optimus guidelines, evaluates the combination of darovasertib and crizotinib as a first-line treatment for patients with HLA-A2-negative metastatic uveal melanoma (MUM). The IDMC recommendation is based on observed clinical efficacy and safety, and it marks a key milestone as the study moves from Part 2a to Part 2b. This positive step supports further enrollment and progress toward potential accelerated approval, meeting a significant need for new treatment options in a patient group with historically poor outcomes.
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IDE161 - FDA Regulatory Timeline and Events
IDE161 is a drug developed by IDEAYA Biosciences for the following indication: PARG Inhibitor in HRD Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IDE161
- Announced Date:
- December 10, 2024
- Indication:
- PARG Inhibitor in HRD Solid Tumors
Announcement
IDEAYA Biosciences, Inc. announced that it has dosed the first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in endometrial cancer patients with high microsatellite instability (MSI-high) and microsatellite stable(MSS).
AI Summary
IDEAYA Biosciences announced that it has dosed the first patient in its Phase 1 trial combining IDE161—its investigational, potential first-in-class PARG inhibitor—with Merck’s KEYTRUDA® (pembrolizumab) for endometrial cancer patients. The trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of this combination in patients with both high microsatellite instability (MSI-high) and microsatellite stable (MSS) tumors. With promising preclinical anti-tumor activity, IDE161 is being explored as part of a strategy to improve outcomes through rational combination therapies. The collaboration involves Merck supplying KEYTRUDA®, while both companies retain their commercial rights over their drugs. Experts expressed optimism that targeting PARG, a novel mechanism within the same pathway as PARP, could offer a breakthrough in the treatment of challenging endometrial cancer cases.
Read Announcement
IDE275 - FDA Regulatory Timeline and Events
IDE275 is a drug developed by IDEAYA Biosciences for the following indication: In MSI-High Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IDE275
- Announced Date:
- March 26, 2025
- Indication:
- In MSI-High Solid Tumors
Announcement
IDEAYA Biosciences, Inc. announced the publication of abstracts for an oral presentation in the New Drugs on the Horizon series, and three poster presentations on IDE275 (GSK959) at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
AI Summary
IDEAYA Biosciences, Inc. announced that it will present data on its investigational drug IDE275 (GSK959) at the AACR Annual Meeting in Chicago, Illinois, scheduled for April 25–30, 2025. The company’s plans include publishing an abstract for an oral presentation in the New Drugs on the Horizon series and delivering three poster presentations focusing on IDE275. This potential best-in-class Werner Helicase (WRN) inhibitor has demonstrated promising preclinical results in high microsatellite instability (MSI-H) solid tumors. IDE275 is currently advancing in a Phase 1 dose escalation trial and shows promise as a monotherapy agent as well as in combination with PD1 inhibitors. The presentations at AACR 2025 will highlight the drug’s selectivity and innovative binding mode, reinforcing its potential role in treating cancers including endometrial, colorectal, and gastric tumors.
Read Announcement
IDE397 - FDA Regulatory Timeline and Events
IDE397 is a drug developed by IDEAYA Biosciences for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IDE397
- Announced Date:
- April 10, 2025
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences, Inc announced the initiation of a Phase 1/2 expansion in the clinical trial evaluating IDE397, its investigational, potential first-in-class, small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC) based on preliminary safety and clinical efficacy data.
AI Summary
IDEAYA Biosciences, Inc. announced the initiation of a Phase 1/2 expansion study evaluating IDE397, its investigational MAT2A inhibitor, in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for patients with methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer. This combination targets a patient population with an estimated 26% prevalence of MTAP-deletion in urothelial cancer. Preliminary safety and clinical efficacy data from earlier phases support the potential of this first-in-class therapeutic approach. IDE397 is designed to inhibit MAT2A selectively in solid tumors with the MTAP deletion, addressing a significant unmet need since there are no approved therapies specifically targeting this genetic profile. The study expansion reflects IDEAYA's commitment to precision medicine by exploring novel combinations that could improve outcomes for patients with specific molecular alterations in their tumors.
Read Announcement- Drug:
- IDE397
- Announced Date:
- February 13, 2025
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences, Inc. announced it has entered into an additional clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion non-small cell lung cancer (NSCLC).
AI Summary
IDEAYA Biosciences, Inc. announced a new clinical study collaboration and supply agreement with Gilead Sciences to evaluate its investigational compound IDE397 in combination with Gilead’s Trodelvy®. IDE397 is a potential first-in-class, small molecule inhibitor of MAT2A, which is aimed at treating cancers with methylthioadenosine phosphorylase (MTAP) deletion. The trial will focus on patients with non-small cell lung cancer (NSCLC) that exhibit MTAP deletion—a mutation present in about 15% of NSCLC cases.
The study expands on current evaluations of the IDE397 and Trodelvy combination, which are already being explored in MTAP-deletion urothelial cancer. This collaborative effort retains commercial rights for each company’s compound and aims to determine the safety and effectiveness of the combination, offering a promising new approach in precision medicine for treating MTAP-deleted solid tumors.
Read Announcement- Drug:
- IDE397
- Announced Date:
- July 8, 2024
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences, announced positive clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients.
AI Summary
IDEAYA Biosciences announced positive Phase 2 clinical data for IDE397, a potential first-in-class MAT2A inhibitor, in patients with MTAP-deletion urothelial and non-small cell lung cancers (NSCLC). In the study, 18 evaluable patients showed promising results at a 30 mg once-daily dose. The overall response rate was 39%, with one complete response and six partial responses noted, while 94% of patients achieved disease control, including those with stable disease. Additionally, 78% of patients experienced tumor shrinkage and an 81% reduction in circulating tumor DNA (ctDNA) levels was observed. The safety profile was encouraging, with approximately 5.6% of patients experiencing grade 3 or higher adverse events and no drug-related serious adverse events or discontinuations. These findings underscore the potential of IDE397 to address the high unmet need for effective treatments in approximately 48,000 U.S. patients with MTAP-deletion solid tumors.
Read Announcement- Drug:
- IDE397
- Announced Date:
- July 5, 2024
- Estimated Event Date Range:
- July 8, 2024 - July 8, 2024
- Target Action Date:
- July 08, 2024
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, July 8, 2024, at 8:00 a.m. EST to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients.
AI Summary
IDEAYA Biosciences announced that it will issue a pre-market press release and hold an investor webcast on Monday, July 8, 2024, at 8:00 a.m. EST. During the webcast, the company will provide a clinical data update on its IDE397 Phase 2 monotherapy expansion dose, which is being tested in patients with MTAP-deletion urothelial and non-small cell lung cancer (NSCLC).
The presentation will review updated clinical data, including patient baseline characteristics, pharmacokinetics, pharmacodynamics, adverse events, and efficacy results according to RECIST 1.1 criteria. Additionally, the event will feature analyses like overall response rate, disease control, and case reports with accompanying CT-scan images. IDEAYA’s leadership team, including CEO Yujiro S. Hata, CMO Darrin Beaupre, and CSO Michael White, will discuss details during this webcast, which investors can access via the company’s Investor Relations website.
Read Announcement- Drug:
- IDE397
- Announced Date:
- June 25, 2024
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences, Inc announced that it has dosed its first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE397, IDEAYA's investigational MAT2A inhibitor
AI Summary
IDEAYA Biosciences, Inc. has reached a significant milestone by dosing the first patient in its IDEAYA-sponsored Phase 1 trial. The trial is evaluating a new combination treatment that pairs IDE397, the company’s investigational MAT2A inhibitor, with Trodelvy®, a Trop-2 directed antibody-drug conjugate from Gilead. This study is focused on patients with MTAP-deletion bladder cancer, a group that faces a poor prognosis. Researchers will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy of this novel combination. According to Dr. Darrin M. Beaupre, the dual-target strategy may bring first-in-class improvements by attacking cancer through two complementary mechanisms. The trial represents an important step toward developing precision therapies aimed at specific genetic features in cancer patients.
Read Announcement- Drug:
- IDE397
- Announced Date:
- June 24, 2024
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences announced clinical program updates for IDE397, a potential first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors.
AI Summary
IDEAYA Biosciences has announced significant updates for its clinical program involving IDE397, a potential first-in-class Phase 2 MAT2A inhibitor designed to target MTAP-deletion solid tumors. The program focuses on treating lung and bladder cancers, with forthcoming clinical data expected in the second half of 2024 from over approximately 15 evaluable patients.
The upcoming data release will include key efficacy results, such as RECIST 1.1 waterfall plots, swim-lane analyses, and ctDNA molecular response evaluations, along with safety information detailing adverse events, pharmacokinetics, and pharmacodynamics. In addition, IDEAYA is expanding its research to include a Phase 2 monotherapy trial in MTAP-deletion bladder cancer, on top of its ongoing study in squamous lung cancer. Over 35 clinical trial sites worldwide have been activated across the U.S., Canada, Europe, and Asia Pacific to support rapid patient enrollment and further evaluate IDE397’s potential.
Read Announcement- Drug:
- IDE397
- Announced Date:
- April 22, 2024
- Indication:
- Solid Tumors
Announcement
IDEAYA Biosciences announced selection of a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous non-small cell lung cancer (NSCLC), based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1.
AI Summary
IDEAYA Biosciences announced that it has selected a Phase 2 expansion dose for IDE397 monotherapy in patients with MTAP-deletion squamous non-small cell lung cancer (NSCLC). This decision was based on the observed adverse event profile and promising preliminary clinical efficacy, which included multiple partial responses according to RECIST 1.1 criteria. The choice was informed by both clinical and preclinical data, where over 40 MTAP patient-derived xenograft models showed that squamous NSCLC was particularly sensitive to IDE397, with about half of the models demonstrating tumor regression at the tested dose.
Company leaders expressed optimism about the potential of IDE397 as a first-in-class MAT2A inhibitor, addressing a significant unmet medical need. They plan to further validate these clinical findings and explore additional combination therapies as they advance their precision medicine approach in this setting.
Read Announcement
IDE849 - FDA Regulatory Timeline and Events
IDE849 is a drug developed by IDEAYA Biosciences for the following indication: In Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IDE849
- Announced Date:
- May 6, 2025
- Indication:
- In Solid Tumors
Announcement
IDEAYA Biosciences announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, in solid tumors.
AI Summary
IDEAYA Biosciences announced that the U.S. Food and Drug Administration (FDA) has cleared their investigational new drug (IND) application, allowing them to begin a Phase 1 clinical trial for IDE849 (SHR-4849). This innovative drug is designed as a first-in-class delta-like ligand 3 (DLL3)-targeting antibody drug conjugate (ADC) with a Topo-I payload. DLL3 is found in higher levels in several solid tumors, such as small cell lung cancer (SCLC) and neuroendocrine tumors (NETs), which means IDE849 could potentially treat multiple cancer types with similar characteristics. The upcoming U.S. Phase 1 trial will study IDE849 both as a standalone treatment in various DLL3-upregulated cancers and in combination with IDE161, another experimental drug, to possibly enhance and extend treatment durability.
Read Announcement
IDE892 - FDA Regulatory Timeline and Events
IDE892 is a drug developed by IDEAYA Biosciences for the following indication: MTA-cooperative PMRT5 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IDE892
- Announced Date:
- December 9, 2024
- Indication:
- MTA-cooperative PMRT5 inhibitor.
Announcement
IDEAYA Biosciences, Inc announced development candidate nomination of IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor.
AI Summary
IDEAYA Biosciences has nominated IDE892 as a new development candidate. IDE892 is a promising best-in-class inhibitor that works by blocking PRMT5 in a way that cooperates with MTA. The drug is both potent and selective, showing favorable properties in lab tests. It has demonstrated strong anti-tumor activity, particularly in models of MTAP-deleted tumor cells, and has led to durable complete responses when used in combination with the MAT2A inhibitor IDE397.
Researchers developed IDE892 using advanced structure-based design and lead optimization techniques. The candidate meets critical target product profiles such as potency, selectivity, and synergistic combination potential. Ongoing IND-enabling studies aim to support an Investigational New Drug filing with the U.S. FDA, which is planned for mid-2025.
Read Announcement
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