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J.P. Morgan Remains Bullish on IDEAYA Biosciences (IDYA)
Yahoo Finance· 2025-10-08 04:57
IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is one of the best biotech stocks with high potential. On September 23, J.P. Morgan analyst Anupam Rama maintained a bullish stance on IDEAYA Biosciences, Inc. (NASDAQ:IDYA), giving the stock a Buy rating with a $74 price target. IDEAYA Biosciences (IDYA) Partners with ATTMOS for AI-Driven Drug Discovery Platform The analyst based the rating on several promising developments associated with the company’s lead asset, darovasertib, stating that IDEAYA Biosciences, Inc ...
Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide
Prnewswire· 2025-09-02 10:00
Core Viewpoint - Servier and IDEAYA Biosciences have entered into an exclusive license agreement for darovasertib, a treatment for uveal melanoma, granting Servier regulatory and commercial rights outside the United States while IDEAYA retains rights in the U.S. [1][7] Company Overview - Servier is an independent international pharmaceutical group focused on delivering transformative therapies and has a strong commitment to oncology, allocating nearly 70% of its R&D budget to this field [10][12] - IDEAYA Biosciences specializes in precision medicine for oncology, focusing on the discovery and development of targeted therapies aligned with genetic drivers of cancer [14] Product Development - Darovasertib is a selective protein kinase C (PKC) inhibitor aimed at treating primary and metastatic uveal melanoma, which is a rare and aggressive form of eye cancer [1][5] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the US FDA, indicating its potential as a significant treatment option [6] Financial Terms of the Agreement - IDEAYA will receive an upfront payment of $210 million, with potential additional payments of up to $320 million based on regulatory and commercial milestones, plus double-digit royalties on net sales outside the U.S. [7][8] Clinical Trials - Darovasertib is currently undergoing multiple global clinical trials, including a Phase 2/3 trial in combination with crizotinib and a Phase 3 trial evaluating it as a monotherapy [4][6] - A global Phase 3 randomized clinical trial is planned for 2026 to assess adjuvant darovasertib in primary uveal melanoma patients [4]
IDEAYA Biosciences to Present First Median Overall Survival Data from Phase 2 Trial of the Darovasertib / Crizotinib Combination in Metastatic Uveal Melanoma at the 2025 Society for Melanoma Research Congress
Prnewswire· 2025-08-29 18:00
Core Insights - IDEAYA Biosciences announced that an abstract from its Phase 1/2 trial of darovasertib combined with crizotinib for first-line metastatic uveal melanoma has been accepted for oral presentation at the 2025 Society for Melanoma Research Congress [1][2] - The presentation will include data from over 40 patients, marking the first reported median overall survival data for the combination treatment in this indication [1][2] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative cancer therapies [2] - The company integrates small-molecule drug discovery, structural biology, and bioinformatics to identify and validate translational biomarkers for developing targeted therapies [2] - IDEAYA has a pipeline that emphasizes synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications, with a mission to enhance clinical outcomes for cancer patients [2]
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, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update
Prnewswire· 2025-08-05 10:00
Core Insights - IDEAYA Biosciences is focused on advancing precision medicines for cancer, with a strong pipeline and upcoming clinical data updates expected by year-end 2025 [1][2]. Pipeline Developments - The Phase 2/3 trial of darovasertib and crizotinib in 1L HLA-A2-negative metastatic uveal melanoma (MUM) is on track to report median progression-free survival (PFS) data by year-end 2025, which could enable a U.S. accelerated approval filing [4][5]. - Initial median overall survival data from over 40 patients in a single-arm Phase 2 trial will be presented at a medical conference in Q4 2025 [4][5]. - A randomized Phase 3 trial, OptimUM-10, will enroll approximately 520 patients in the neoadjuvant setting for primary UM, initiated in Q3 2025 [6]. Upcoming Milestones - IDEAYA will host a 10-year Anniversary R&D Day on September 8, 2025, to present multiple clinical data updates and strategic vision [2][10]. - Three investigational new drug (IND) applications are on track for submission by year-end 2025, including IDE892, IDE034, and IDE574 [4][11]. Financial Results - As of June 30, 2025, IDEAYA had approximately $991.9 million in cash, cash equivalents, and marketable securities, down from $1.05 billion as of March 31, 2025 [14][23]. - Research and development expenses for Q2 2025 totaled $74.2 million, an increase from $70.9 million in Q1 2025, primarily due to higher clinical trial expenses [15]. - The net loss for Q2 2025 was $77.5 million, compared to a net loss of $72.2 million in Q1 2025 [17].
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, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update
Prnewswire· 2025-05-06 10:05
Core Insights - IDEAYA Biosciences, Inc. provided a business update and announced financial results for Q1 2025, highlighting significant progress in its clinical programs and financial position [1][2]. Financial Overview - As of March 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, down from $1.08 billion at the end of 2024, primarily due to operational cash usage [4][16]. - The company projects that its current cash balance will fund operations into 2029 based on its updated operating plan [17]. - The net loss for Q1 2025 was $72.2 million, a decrease from a net loss of $130.3 million in Q4 2024 [22]. Clinical Development Highlights - The darovasertib program received U.S. FDA breakthrough therapy designation, with over 300 patients enrolled in the registrational trial for HLA-A2-negative metastatic uveal melanoma (MUM) [2][4]. - The company is targeting a median progression-free survival (PFS) readout by the end of 2025 to enable a potential accelerated approval filing [4][5]. - IDEAYA is advancing multiple clinical programs, including IDE849 for lung cancer, IDE275 for MSI-high colorectal and endometrial cancer, and IDE397 for MTAP-deletion lung and urothelial cancer [2][4]. Research and Development Updates - The Phase 3 trial for darovasertib as neoadjuvant therapy for primary uveal melanoma is expected to enroll approximately 520 patients, with a focus on eye preservation and visual acuity outcomes [5][6]. - IDEAYA plans to present clinical data updates at medical conferences throughout 2025, including results from darovasertib and other pipeline candidates [4][5]. - The company has initiated a Phase 1 study for IDE849 in small cell lung cancer (SCLC) and is collaborating with Gilead to evaluate IDE397 in combination with Trodelvy® [12][19]. Corporate Developments - IDEAYA appointed Joshua Bleharski as Chief Financial Officer and Shanthakumar Tyavanagimatt as Senior Vice President of Technical Operations, enhancing its leadership team [21]. - The company formed a collaboration with ATTMOS to develop a computational platform for small molecule discovery, aiming to unlock oncology targets [21].
IDEAYA Biosciences Announces Successful FDA Type D Meeting on Phase 3 Registrational Trial Design for Darovasertib as Neoadjuvant Therapy for Primary Uveal Melanoma
Prnewswire· 2025-04-14 10:00
Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]
IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma
Prnewswire· 2025-03-31 10:00
Core Insights - IDEAYA Biosciences has received FDA Breakthrough Therapy designation for darovasertib, a potential first-in-class PKC inhibitor, aimed at treating adult patients with primary uveal melanoma who are recommended for enucleation [1][2] Group 1: FDA Designation and Clinical Trials - The Breakthrough Therapy designation will facilitate the advancement of darovasertib into a potential Phase 3 registrational trial for primary uveal melanoma [2][6] - The application for BTD was supported by interim clinical data from an ongoing Phase 2 trial, showing an 82% ocular tumor shrinkage rate and a 61% eye preservation rate in patients [4][8] - A Phase 3 registrational study is targeted to be initiated in the first half of 2025, focusing on neoadjuvant darovasertib for patients eligible for enucleation or plaque brachytherapy [5][8] Group 2: Market Potential and Unmet Needs - Neoadjuvant uveal melanoma has an estimated annual incidence of approximately 12,000 patients in North America, Europe, and Australia, representing a significant unmet medical need with no FDA-approved systemic therapies currently available [5][8] - The FDA has also granted Fast Track designation for darovasertib in combination with crizotinib for metastatic uveal melanoma, with an ongoing Phase 2/3 trial [3][4] Group 3: Company Overview and Strategy - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics [7] - The company integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [7]