IDEAYA Biosciences(IDYA)

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IDEAYA Biosciences Announces Agenda for 10-Year Anniversary R&D Day on September 8, 2025
Prnewswire· 2025-08-18 10:00
Core Insights - IDEAYA Biosciences, Inc. is hosting an in-person R&D Day on September 8, 2025, in New York to celebrate its 10-Year Anniversary and discuss its progress and future growth strategy [1][2]. Company Overview - IDEAYA is a precision medicine oncology company focused on discovering and developing targeted therapeutics for cancer, integrating small-molecule drug discovery, structural biology, and bioinformatics [6]. R&D Day Agenda - The R&D Day will feature presentations on new clinical data for darovasertib in neoadjuvant uveal melanoma, IDE849 (DLL3 TOP1 ADC), and IDE397 (MAT2A) [2][8]. - Dr. Arun D. Singh from the Cleveland Clinic will present data from the Phase 2 trial of darovasertib and discuss the Phase 3 OptimUM-10 trial [4]. - The agenda includes discussions on various drug candidates, including initial Phase 1 clinical data for IDE397/Trodelvy combination in MTAP-deletion urothelial cancer and the application of AI/ML in discovery capabilities [8].
IDEAYA Biosciences(IDYA) - 2025 Q2 - Quarterly Report
2025-08-05 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38915 IDEAYA Biosciences, Inc. (Exact name of registrant as specified in its charter) FORM 10-Q (Mark One) 5000 Shoreline Court, Suite 300 So ...
IDEAYA Biosciences(IDYA) - 2025 Q2 - Quarterly Results
2025-08-05 10:04
Exhibit 99.1 IDEAYA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update SOUTH SAN FRANCISCO, Calif., August 5, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology company committed to advancing the discovery, development, and commercialization of transformative precision medicines to address unmet medical needs in cancer, provided a business update and announced financial results for the second quarter ended June 30, 2025. Darovasertib • Metasta ...
IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2025 for Phase 2 Clinical Trial of Neoadjuvant Darovasertib in Primary Uveal Melanoma
Prnewswire· 2025-07-24 13:25
Core Insights - IDEAYA Biosciences announced that results from a global Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma will be presented at the 2025 ESMO meeting in Berlin [1][2] - The presentation will focus on the effects of darovasertib across plaque brachytherapy and enucleation cohorts, highlighting its potential impact on disease management [2][3] - The company has initiated a randomized Phase 3 neoadjuvant registrational trial (OptimUM-10) for darovasertib in primary uveal melanoma [6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer [3] - The company integrates drug discovery, structural biology, and bioinformatics to create targeted therapies for specific patient populations [3] - IDEAYA has a robust pipeline that includes therapies based on synthetic lethality and antibody-drug conjugates [3] Clinical Study Details - The upcoming presentation will include data from over 90 patients in both plaque brachytherapy and enucleation-eligible cohorts [6] - Darovasertib has received U.S. FDA Breakthrough Therapy Designation for neoadjuvant use in uveal melanoma patients requiring enucleation [6]
IDEAYA Biosciences Announces 10-Year Anniversary R&D Day on September 8, 2025 to Present Multiple Clinical Data Updates and Outline Future Growth Strategy
Prnewswire· 2025-07-23 10:00
Core Insights - IDEAYA Biosciences, Inc. will host an in-person and virtual R&D Day on September 8, 2025, to present clinical data updates and discuss growth drivers and upcoming milestones [1][2] - The event will feature members of IDEAYA's senior leadership team and key opinion leaders [3] - IDEAYA is celebrating its ten-year anniversary and aims to highlight its strategic vision and emerging clinical pipeline [2] Company Overview - IDEAYA is a precision medicine oncology company focused on discovering, developing, and commercializing transformative therapies for cancer [4] - The company integrates small molecule drug discovery, structural biology, and bioinformatics to develop potentially first-in-class targeted therapies [4] - IDEAYA has a robust pipeline that includes targeted therapies focused on synthetic lethality and antibody-drug conjugates (ADCs) [4]
IDEAYA Biosciences and Hengrui Pharmaceuticals Announce Oral Presentation at IASLC 2025 World Conference on Lung Cancer for IDE849 (SHR-4849), a Potential First-in-Class DLL3-TOP1 ADC
Prnewswire· 2025-07-22 17:01
Core Insights - IDEAYA Biosciences and Jiangsu Hengrui Pharmaceuticals announced an oral presentation on IDE849 (SHR-4849) at the IASLC 2025 World Conference on Lung Cancer, focusing on its efficacy and safety in small-cell lung cancer (SCLC) patients [1][3] - IDE849 is a potential first-in-class DLL3-targeting Topoisomerase-1 (TOP1) payload antibody drug conjugate (ADC), addressing significant unmet medical needs in various solid tumors [1][3] Group 1: Presentation Details - The oral presentation will take place on September 7, 2025, from 4:45-6:00 PM (CET) and will cover a Phase 1 study of SHR-4849 (IDE849) in relapsed SCLC [4] - A poster presentation will also be held on September 8, 2025, discussing the combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, a proprietary PARG inhibitor [2][5] Group 2: Clinical Development - The Phase 1 trial for IDE849 is ongoing in China, with data from over 70 SCLC patients expected to be presented, including results from dose escalation and multiple expansion doses [6] - The U.S. Phase 1 trial of IDE849 in SCLC patients was initiated in the third quarter of 2025 [6] Group 3: Company Strategy - IDEAYA aims to evaluate rational combinations of therapies to improve clinical outcomes for cancer patients, including the use of IDE849 as a monotherapy and in combination with immunotherapy and IDE161 [2][3] - The company has a robust pipeline focused on synthetic lethality and ADCs, including bispecifics, to address unmet medical needs in cancer [7]
IDEAYA Biosciences to Participate in Upcoming July 2025 Investor Relations Event
Prnewswire· 2025-07-21 10:00
Group 1 - IDEAYA Biosciences, Inc. is participating in the 2025 BTIG Virtual Biotechnology Conference on July 29, 2025, at 4:40 PM ET, featuring a fireside chat with CEO Yujiro S. Hata [1] - The conference will be accessible via a live audio webcast on the IDEAYA website, with a replay available for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative therapies for unmet medical needs in cancer [2] - The company integrates small molecule drug discovery, structural biology, and bioinformatics to develop targeted therapies, including synthetic lethality and antibody-drug conjugates (ADCs) [2] - IDEAYA has established a robust pipeline of targeted therapies aimed at improving clinical outcomes for cancer patients [2]
IDEAYA Biosciences (IDYA) FY Conference Transcript
2025-06-09 15:40
Summary of IDEA Biosciences Conference Call Company Overview - **Company**: IDEA Biosciences - **Focus**: Development of innovative therapies for cancer treatment, with six clinical programs currently and a target of nine by year-end [2][1]. Key Value Drivers - **Lead Program**: Derobicertib, targeting metastatic human melanoma, currently in a registrational trial [2][1]. - **Enrollment Status**: Completed enrollment for the trial, with over 320 patients enrolled, exceeding the target of 250 [12][13]. - **Primary Endpoint**: Median progression-free survival (PFS) is crucial for potential accelerated approval, with historical PFS around 2-3 months and a target of over 5.5 months for the current study [3][8]. Clinical Data and Updates - **PFS Results**: Previous studies showed a PFS of approximately 7 months, with a specific setting achieving nearly 11 months [10][11]. - **Overall Survival (OS)**: Anticipated update on OS data from the phase two study, with historical OS in treatment-naive settings around 12-13 months [17][18]. - **Market Opportunity**: Targeting the HLA A2 negative population, with an estimated annual incidence of 4,000 to 5,000 patients in the US and Europe [20][19]. Commercial Strategy - **Commercial Organization**: Building a commercial team with key hires, including a Chief Commercial Officer and heads of various departments [24][25]. - **Regulatory Strategy**: Fast track designation from the FDA for expedited review, with ongoing discussions regarding NDA submission [14][16]. Pipeline and Future Developments - **Additional Programs**: Focus on MTAP deletion space and DLL3, with several data catalysts expected [5][6][51]. - **Combination Therapies**: Emphasis on rational combinations, particularly with PRMT5 inhibitors in lung cancer [70][71]. - **IND Filings**: Targeting multiple INDs, with a goal of one IND per year, and a record of four INDs planned for the current year [86][87]. Financial Position - **Cash Reserves**: Reported over $1 billion in cash, providing a strong financial position for ongoing and future clinical activities [88][87]. Conclusion - IDEA Biosciences is positioned for significant growth with multiple clinical programs, a robust commercial strategy, and a strong financial foundation, aiming to address unmet needs in cancer treatment through innovative therapies and strategic partnerships.
IDEAYA Biosciences (IDYA) 2025 Conference Transcript
2025-06-04 13:12
Summary of IDEAYA Biosciences (IDYA) Conference Call Company Overview - IDEAYA Biosciences is a leading precision medicine oncology company founded about a decade ago with six clinical programs and a target of nine by the end of the year [4][5] Key Clinical Programs - **Durovacertib**: Currently in a pivotal registration enabling trial targeting frontline approval in HLA A2 negative metastatic melanoma, with a potential readout for accelerated approval by year-end based on median progression-free survival (PFS) [5][7] - **Clinical Data**: Historical median PFS in metastatic uveal melanoma is 2-3 months; IDEAYA reported a median PFS of approximately 7 months at ESMO 2023, aiming for a PFS of over 5.5 months in their study [7][21] - **Enrollment**: Target enrollment for the PFS study was 250 patients, but over 320 patients have been enrolled, with expectations to complete full enrollment by year-end [9][10] Upcoming Data and Regulatory Plans - **OS Readout**: The overall survival (OS) readout is expected to occur concurrently with the PFS readout, with preliminary data anticipated by mid-2026 [14][15] - **NDA Filing**: Fast track designation in the metastatic setting and breakthrough therapy designation in the neoadjuvant setting will facilitate NDA submission post-results [19][20] Market Opportunity - **HLA A2 Negative Population**: The company sees a significant commercial opportunity in the HLA A2 negative patient population, with approximately 70% of screened patients being HLA A2 negative [26][29] - **Chemtrac Comparison**: Chemtrac from Immunocor has shown strong growth with a run rate of $375 million, indicating a robust market potential for IDEAYA's products [26] Neoadjuvant Study - **Phase III Study Design**: The study includes two cohorts (enucleation and plaque therapy) with primary endpoints focused on eye preservation and vision tests, respectively [34][35] - **Enrollment Timeline**: Anticipated enrollment of 520 patients over five quarters, with the first readout expected within a year [38][40] DLL3 Topical ADC - **Differentiation**: IDEAYA's DLL3 ADC is expected to differentiate based on its tetrapeptide cleavable linker, which cleaves upon internalization, compared to competitors [49][50] - **Data Expectations**: A medical conference update is expected in the third quarter, with data on response rates and adverse event profiles [51][56] MAT2A Inhibitor and Combination Studies - **Combination with Trodelvy**: IDEAYA is optimistic about achieving a response rate above 40% in combination studies with Gilead's Trodelvy in urothelial carcinoma [65] - **PRMT5 Inhibitor**: The company plans to submit an IND for a combination therapy with its PRMT5 inhibitor, aiming for greater response rates compared to monotherapy [67][70] Financial Position - **Cash Reserves**: As of March, the company reported over $1 billion in cash, providing runway into 2029 and flexibility for continued investment in its pipeline [78][79] Upcoming Catalysts - **Data Readouts**: IDEAYA anticipates four data readouts for durovacertib and a substantial update on DLL3 in the third quarter, along with plans for an R&D day by year-end [82][83]
IDEAYA Biosciences to Participate in Upcoming June 2025 Investor Relations Events
Prnewswire· 2025-06-02 10:00
Group 1 - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events: the 2025 Jefferies Global Healthcare Conference on June 4th and the Goldman Sachs 46th Annual Global Healthcare Conference on June 9th [1] - The CEO, Yujiro S. Hata, will be featured in fireside chats at both conferences, hosted by equity research analysts from Jefferies and Goldman Sachs [1] - A live audio webcast of the events will be available on the IDEAYA website, with replays accessible for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to optimize patient selection for its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]