IDEAYA Biosciences(IDYA)
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IDEAYA Biosciences to Participate in Upcoming February 2026 Investor Relations Events
Prnewswire· 2026-02-02 11:00
SOUTH SAN FRANCISCO, Calif., Feb. 2, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events. Citi's 2026 Virtual Oncology Leadership SummitWednesday, February 18th, 2026 at 1:00 PM ET Fireside chat with Darrin Beaupre, Chief Medical Officer; Michael White, Chief Scientific Officer; and Joshua Bleharski, Chief Financial Offic ...
IDEAYA Biosciences, Inc. (IDYA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-13 06:45
Company Overview - IDEAYA was founded 10 years ago and has established strategic guideposts including first-in-class targets, predictive biomarkers, rational combinations, and early-stage disease focus areas [3] Clinical Pipeline - The company has four clinical pipeline focus areas, with darovasertib being a key program currently in a registrational study, with top-line results expected this quarter for potential accelerated approval filing in the United States [4] - Darovasertib is considered a unique molecule with the potential to define its indication in uveal melanoma across neoadjuvant, adjuvant, and metastatic settings [4] Research Focus - IDEAYA is also focusing on antibody-drug conjugates (ADCs) and DNA damage repair as part of its research and development strategy [5]
IDEAYA Biosciences (NasdaqGS:IDYA) FY Conference Transcript
2026-01-13 00:47
Summary of IDEAYA Biosciences FY Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **CEO**: Yujiro Hata Key Focus Areas 1. **Darovasertib**: - Currently in a registrational study with top-line results expected this quarter for potential accelerated approval in the U.S. [2][8] - Targets uveal melanoma, a rare and aggressive cancer with a poor prognosis (5-year survival rate of 15%-20%) [6][7] - Reported an overall response rate of approximately 35% and a median duration of response of nine months [7] - Progression-free survival (PFS) reported at seven months, with overall survival (OS) over 21 months [7] - Received Breakthrough Therapy Designation from the FDA for the neoadjuvant setting [9] 2. **Antibody-Drug Conjugates (ADCs)**: - Focus on DNA damage repair and enhancing durability of ADCs [11][12] - DLL3 TOPO-ADC program (ID849) aims to address unmet needs in small cell lung cancer, with a confirmed response rate of approximately 70% in second-line settings [15][16] - Plans to initiate a registrational study for ID849 targeting monotherapy accelerated approval [17] 3. **MTAP Deletion**: - Represents a significant opportunity as it is co-deleted with CDKN2A in various cancers, including lung and pancreatic cancers [19][20] - No FDA-approved therapies currently exist for patients with MTAP deletion [20] - Response rates of approximately 40% reported in ongoing studies, with a focus on non-small cell lung cancer [21][22] 4. **KAT6/7 Inhibitors**: - New dual KAT6/7 inhibitor (ID574) has entered phase one trials, targeting tumor heterogeneity [24] - Expected to address significant patient populations in breast cancer, prostate cancer, and colorectal cancer [24] Clinical Development and Strategy - IDEAYA has a pipeline of nine clinical stage molecules, focusing on precision medicine in oncology [5] - Emphasis on combination therapies to enhance treatment efficacy and durability [29] - Plans to complete enrollment for the neoadjuvant study by the first half of 2027 [11] Market Insights - IDEAYA aims to learn from the Kimmtrak launch in the uveal melanoma market to enhance its market entry strategy for darovasertib [28] - The company is focused on addressing challenges in community access and market penetration [28] Financial and Operational Highlights - IDEAYA is positioned for potential accelerated approval filings and is investing in future growth areas, including TOPO-ADCs and MTAP deletion biology [25] Additional Considerations - The company is exploring the safety and efficacy of various combinations, including the potential for reduced doses to optimize therapeutic windows [40][41] - The focus on systemic therapies versus dual payload approaches highlights a strategic differentiation in their clinical development [42] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA's strategic focus, clinical developments, and market positioning.
IDEAYA Biosciences (NasdaqGS:IDYA) FY Earnings Call Presentation
2026-01-12 23:45
January 2026 Improving Lives Through Transformative Precision Medicines JPM 2026 | 44th Annual Healthcare Conference NASDAQ: IDYA Safe Harbor Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of IDEAYA Biosciences, Inc. (the "Company") and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, perfor ...
IDEAYA Biosciences Provides a Business Update and Outlines 2026 Corporate Objectives at the 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-11 17:00
Core Insights - IDEAYA Biosciences, Inc. is focused on advancing its oncology pipeline and achieving key corporate objectives in 2026, with a significant emphasis on darovasertib for uveal melanoma and other cancer indications [1][2] Corporate Objectives for 2026 - The company plans to advance four registrational trials, including darovasertib in both pre-metastatic and metastatic settings of uveal melanoma, which is critical for improving patient outcomes in this high-unmet-need area [2][3] - Topline results from the OptimUM-02 trial, which involves a combination of darovasertib and crizotinib in HLA*A2-negative metastatic uveal melanoma patients, are expected in Q1 2026, potentially leading to an accelerated approval filing in the U.S. [3] - Three randomized Phase 3 registrational trials for darovasertib across all stages of uveal melanoma are anticipated to be initiated by H1 2026 [3] - The company aims to initiate a registrational study for IDE849 in the second line/refractory setting of small cell lung cancer by the end of 2026 [3] Pipeline and Clinical Trials - IDEAYA's pipeline includes multiple candidates targeting various cancers, with specific trials planned for IDE034, IDE161, IDE397, and IDE892, among others, throughout 2026 [3][4] - The company has a strong cash position of approximately $1.1 billion as of September 30, 2025, which is expected to fund operations into 2030 [8] Strategic Focus - IDEAYA is committed to precision medicine and aims to develop transformative therapies for cancer, leveraging its expertise in drug discovery and biomarker validation [5]
IDEAYA Biosciences Announces Participation at the 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-05 11:00
SOUTH SAN FRANCISCO, Calif., Jan. 5, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation at the 44th Annual J.P. Morgan Healthcare Conference. th44th Annual J.P. Morgan Healthcare ConferenceMonday, January 12, 2026, at 3:45 PM PT (6:45 PM ET) Presentation by Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences, followed by analyst-hosted Q&A with Anupam Ra ...
Biotech Stocks Shine After Hours: Novo Nordisk, IDEAYA, Healthcare Triangle Among Gainers
RTTNews· 2025-12-23 04:49
Core Insights - Healthcare and biotechnology stocks experienced significant movements in after-hours trading, with several companies showing strong gains despite limited news flow [1] Company Summaries - Novo Nordisk A/S (NVO) saw a notable increase of 9.48%, closing at $52.66, following FDA approval of its Wegovy pill, the first oral GLP-1 medicine for obesity in the U.S., which is also approved to reduce cardiovascular risks [2] - Neumora Therapeutics, Inc. (NMRA) advanced 16.02% to $2.10, indicating investor interest possibly driven by broader sector momentum or speculative trading, as there were no specific news updates [3] - BioRestorative Therapies, Inc. (BRTX) rose 6.90% to $1.24, with investors reacting to a prior announcement regarding an FDA Type B meeting to discuss a potential accelerated BLA pathway for its BRTX-100 program for chronic lumbar disc disease [4] - RenovoRx, Inc. (RNXT) added 4.44% to close at $0.94, with earlier news of an accepted abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026 contributing to investor interest [5] - IDEAYA Biosciences, Inc. (IDYA) gained 6.49% to $37.81, following the full enrollment of 435 patients in its Phase 2/3 trial for darovasertib, with expected data reporting in Q1 2026 [6] - Healthcare Triangle, Inc. (HCTI) climbed 6.72% to $1.43, with a recent announcement of an Advance Agreement for acquiring AI-powered customer experience firms, enhancing its position in global AI-driven solutions [7] - Alphatec Holdings, Inc. (ATEC) posted a modest gain of 2.80%, rising to $21.28, benefiting from ongoing investor confidence in the spine surgery provider [8]
IDEAYA Biosciences Completes Targeted Full Enrollment in Randomized Pivotal Phase 2/3 Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA*A2-Negative Metastatic Uveal Melanoma
Prnewswire· 2025-12-11 11:00
Core Insights - IDEAYA Biosciences has completed the targeted enrollment of 435 patients in the Phase 2/3 trial (OptimUM-02) for darovasertib in combination with crizotinib for treating first-line HLA*A2-negative metastatic uveal melanoma [1][2] - The company anticipates reporting median progression-free survival (PFS) data in Q1 2026 to support a potential accelerated approval filing in the U.S. [1][6] - Darovasertib has received FDA Breakthrough Therapy Designation and Fast Track designation for its use in metastatic uveal melanoma [4] Trial Details - The OptimUM-02 trial is a multi-arm, multi-stage, open-label study comparing the darovasertib and crizotinib combination against investigator's choice of treatment [3] - Primary endpoints include median PFS and median overall survival (OS), which will support potential accelerated and full approval filings in the U.S. [3] - Previous data from the Phase 1/2 trial (OptimUM-01) indicated a median OS of 21.1 months and median PFS of 7.0 months for the combination treatment [3] Regulatory Designations - Darovasertib has been designated as an Orphan Drug by the U.S. FDA for uveal melanoma, including metastatic cases [4] - The company is also enrolling patients in a pivotal Phase 3 trial of single-agent darovasertib in the neoadjuvant setting for primary uveal melanoma (OptimUM-10) [4] Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to develop transformative therapies for cancer through a combination of drug discovery, structural biology, and bioinformatics [5] - The company has a pipeline targeting synthetic lethality and antibody-drug conjugates for solid tumor indications [5]
IDEAYA Biosciences Announces IND Submission for IDE574, a Potential First-In-Class KAT6/7 Dual Inhibitor for Breast and Lung Cancers
Prnewswire· 2025-12-10 11:00
Core Insights - IDEAYA Biosciences has submitted an investigational new drug (IND) application for IDE574, a potential first-in-class KAT6/7 dual inhibitor, to the FDA, with plans to initiate a Phase 1 trial in Q1 2026 [1][7] Group 1: Product Development - IDE574 is designed to selectively inhibit KAT6 and KAT7, which are involved in tumor cell proliferation and survival, while sparing other KAT family members [2][3] - Preclinical studies indicate that dual inhibition of KAT6 and KAT7 by IDE574 disrupts tumor lineage identity and shows significant anti-tumor activity in lung and breast cancer models [2][3] - The company aims to present preclinical data on IDE574's pharmacologic profile and anti-tumor activity at a medical conference in the first half of 2026 [3][7] Group 2: Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, emphasizing the discovery and development of targeted therapies aligned with genetic disease drivers [4] - The company has developed a pipeline of product candidates targeting synthetic lethality and antibody-drug conjugates for solid tumor indications [4]
港股异动 涨超3% 授权IDEAYA双抗ADC项目IDE034获FDA IND批准
Zhi Tong Cai Jing· 2025-12-05 07:29
Core Viewpoint - The approval of the IND for IDEAYA's dual-target ADC project IDE034 by the FDA marks a significant advancement in the development of innovative cancer therapies, potentially enhancing the company's market position and investor interest [1][2]. Group 1: Company Developments - 百奥赛图-B's stock rose over 3%, reaching 31.86 HKD with a trading volume of 12.99 million HKD following the announcement of FDA IND approval for IDEAYA's IDE034 project [1]. - IDEAYA Biosciences, Inc. plans to initiate patient enrollment for the Phase I clinical trial in Q1 2026, focusing on solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1]. Group 2: Clinical Research Insights - Preclinical studies indicate that IDE034 demonstrates deep and durable tumor regression in various B7H3/PTK7 positive tumor models, showcasing strong anti-tumor activity [2]. - IDEAYA intends to explore a combination therapy strategy with its PARG inhibitor IDE161 to enhance the durability of treatment effects, with plans to present additional data on the combined treatment mechanism at a major medical conference in H1 2026 [2]. - The co-expression rates of B7H3/PTK7 in solid tumors are approximately 30% in lung cancer, 46% in colorectal cancer, and 27% in head and neck cancer, indicating broad clinical applicability [2].