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IDEAYA Biosciences, Inc. (NASDAQ: IDYA) is an innovative biotechnology firm concentrated on oncology. Established in 2015 and headquartered in South San Francisco and La Jolla, California, the company is dedicated to the discovery and development of precision medicine therapies for genetically defined patient groups. Their focus areas include synthetic lethality and immuno-oncology, targeting DNA damage repair mechanisms and the tumor microenvironment, respectively.
IDEAYA's pioneering approach leverages molecular diagnostics to identify and develop targeted therapeutics. The company's leading product candidate, IDE196, is a potent inhibitor of protein kinase C (PKC), aimed at treating cancers with GNAQ or GNA11 mutations. In addition, IDEAYA is advancing several clinical programs, such as the darovasertib program, which is currently in Phase 2 trials for uveal melanoma (UM) and has shown promising results in tumor shrinkage and eye preservation.
In synthetic lethality, IDEAYA's IDE397 targets methionine adenosyltransferase 2 alpha (MAT2A) in solid tumors with MTAP deletion, a condition prevalent in 15% of solid tumors. The IDE397 program includes both monotherapy and combination trials with other investigational drugs.
Financially, IDEAYA is robust with cash reserves exceeding $941.4 million as of Q1 2024, ensuring operational funding through 2028. Key investors include 5AM Ventures, Canaan Partners, and Celgene. The company has formed strategic collaborations with major pharmaceutical players like Pfizer, Amgen, Gilead Sciences, GSK, and Merck to amplify its research and clinical capabilities.
IDEAYA's scientific advisory board is composed of esteemed researchers, including a Nobel laureate and members of the National Academy of Sciences, underscoring the company's commitment to groundbreaking research.
Recent developments are promising: IDEAYA reported favorable Phase 2 trial results for IDE196 in UM, with significant tumor reduction and eye preservation rates. Additionally, a collaboration with Merck for the IDE161 program aims to tackle endometrial cancer using advanced immunotherapy combinations.
For more detailed updates and financial information, visit IDEAYA's Investor Relations page.
IDEAYA Biosciences (NASDAQ: IDYA) announced its participation at the 43rd Annual J.P. Morgan Healthcare Conference and provided 2025 corporate guidance. The company reported $1.2 billion in cash as of September 30, 2024, expected to fund operations into at least 2028.
Key program updates include: darovasertib Phase 2/3 trial progression with over 200 patients enrolled; IDE397 Phase 1/2 study developments; IDE849 clinical program updates in SCLC and NETs; and planned expansion of IDE161 in combination with KEYTRUDA®. The company targets three IND filings in 2025, potentially bringing their clinical-stage precision medicine oncology programs to nine.
Notable milestones include median progression-free survival readout for darovasertib by year-end 2025, Phase 3 trial initiation in first half 2025, and multiple clinical program updates across their pipeline throughout the year.
IDEAYA Biosciences (NASDAQ: IDYA) has secured an exclusive global license outside Greater China for SHR-4849, a Phase 1 DLL3-targeting antibody drug conjugate (ADC) from Hengrui Pharma. The drug targets Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs), showing promising early clinical results with a ~73% response rate in SCLC patients at therapeutic doses. The deal includes a $75M upfront payment and potential milestone payments totaling $1.045B, plus royalties.
In the ongoing Phase 1 trial, SHR-4849 demonstrated 8 partial responses among 11 evaluable SCLC subjects, with manageable safety profile primarily showing Grade 1 or 2 adverse events. IDEAYA plans to file a US IND in H1 2025. The agreement maintains IDEAYA's guided cash runway through at least 2028.
IDEAYA Biosciences (NASDAQ: IDYA) has announced that its Compensation Committee granted non-qualified stock options to a newly hired employee on December 26, 2024. The grant includes options to purchase 31,400 shares of common stock at an exercise price of $25.86 per share, matching the closing price on Nasdaq Global Select Market on the grant date.
The options were granted under the company's 2023 Employment Inducement Incentive Award Plan and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following three years. The options have a 10-year term and are subject to continued employment.
IDEAYA Biosciences announced that the Independent Data Monitoring Committee (IDMC) has recommended a move-forward dose in Part 2a of their potential registration-enabling Phase 2/3 trial for the darovasertib and crizotinib combination in first-line HLA-A2-negative metastatic uveal melanoma (MUM) patients. The trial has enrolled over 185 patients and received FDA Fast Track designation.
The recommendation allows completion of Part 2a and seamless continuation to Part 2b, targeting potential accelerated approval based on median progression free survival. The combination therapy is being evaluated in two clinical trials, including the Phase 2/3 registration-enabling trial and a separate Phase 2 trial. Additionally, darovasertib is being studied as neoadjuvant monotherapy in primary uveal melanoma, with plans to initiate a Phase 3 registration-enabling study in first half of 2025.
IDEAYA Biosciences (NASDAQ: IDYA) has nominated IDE251 as its development candidate, representing a potential first-in-class KAT6/7 dual inhibitor targeting cancer treatments. IDE251 is specifically designed to target breast and non-small cell lung cancer (NSCLC) with 8p11 amplification, which affects approximately 15% of breast cancer patients and 17.5% of squamous NSCLC cases.
The drug has demonstrated strong and lasting anti-tumor activity in preclinical studies, particularly in biomarker-positive breast and lung xenografts models. IDE251 selectively inhibits both KAT6 and KAT7 epigenetic modulators while avoiding other KAT family members. The company is currently conducting IND-enabling studies and plans to submit an Investigational New Drug (IND) application to the FDA in 2025.
IDEAYA Biosciences (NASDAQ: IDYA) has announced its virtual Investor R&D Day Webcast scheduled for December 16, 2024, from 8:00 am to 9:30 am ET. The event will showcase the company's precision medicine oncology pipeline, featuring presentations on multiple drug candidates including:
- IDE275/GSK959: Phase 1 Werner Helicase inhibitor
- IDE892: MTA-cooperative PMRT5 inhibitor
- IDE034: B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate
- A lysine acetyltransferase 6/7 development candidate
The agenda includes discussions on uveal melanoma treatment, tumor heterogeneity, and drug resistance. Distinguished speakers from institutions including Wills Eye Hospital, Dana-Farber Cancer Institute, and MD Anderson Cancer Center will participate. The presentation will be available on the company's website at 6:00 am ET.
IDEAYA Biosciences (Nasdaq:IDYA) has initiated its Phase 1 clinical trial by dosing the first patient with IDE161 in combination with KEYTRUDA® for endometrial cancer treatment. IDE161, a potential first-in-class PARG inhibitor, will be evaluated alongside Merck's anti-PD-1 therapy in patients with MSI-high and MSS endometrial cancer.
The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the combination therapy. IDE161 has received two FDA Fast Track designations for treating platinum-resistant ovarian cancer with BRCA1/2 mutations and pretreated HR+, Her2-, BRACA1/2 mutant breast cancer. The company has also selected an initial Phase 1/2 monotherapy expansion dose based on adverse event profile and preliminary clinical efficacy.
IDEAYA Biosciences (Nasdaq: IDYA) has nominated IDE892 as a development candidate, representing their 7th development candidate overall. IDE892 is a potent and selective MTA-cooperative PRMT5 inhibitor designed for treating MTAP-deletion solid tumors.
The compound demonstrates favorable drug-like properties and has shown exceptional selective antiproliferative activity in MTAP-deleted tumor cell models. When combined with MAT2A inhibitor IDE397, it achieved durable complete responses in preclinical models.
The company is currently conducting IND-enabling studies and targets an IND filing with the FDA in mid-2025, subject to successful completion of ongoing preclinical studies.
IDEAYA Biosciences (NASDAQ: IDYA) has announced that its Compensation Committee granted non-qualified stock options to a newly hired employee on December 2, 2024. The grant includes options to purchase 170,000 shares of common stock at an exercise price of $27.45 per share, matching the closing price on Nasdaq Global Select Market on the grant date.
The options were granted under the company's 2023 Employment Inducement Incentive Award Plan, complying with Nasdaq Listing Rule 5635(c)(4). These options have a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following three years, subject to continued employment.
IDEAYA Biosciences (NASDAQ: IDYA) has announced its participation in two upcoming investor events in December 2024. The company will participate in Citi's 2024 Global Healthcare Conference on December 3rd at 8:00 AM ET, featuring a fireside chat with CEO Yujiro S. Hata. Additionally, IDEAYA will attend the 7th Annual Evercore HealthCONx Conference on December 4th at 1:20 PM ET. Live audio webcasts will be available on IDEAYA's website investor section, with replays accessible for 30 days after the events.
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