Development Candidate IDE251 - IDE251 is a potential first-in-class KAT6/7 dual inhibitor, designed to selectively target both KAT6 and KAT7 while sparing other structurally similar KAT family members [1][3] - The molecule demonstrates robust and durable monotherapy anti-tumor activity in preclinical models, particularly in biomarker-positive breast and lung cancer xenografts with 8p11 amplification [1][3] - IDE251 is targeted for evaluation in breast cancer and squamous non-small cell lung cancer (NSCLC) with 8p11 amplification, which occurs in approximately 15% of breast cancer patients and up to 17.5% in squamous NSCLC [1][2][4] Preclinical and Clinical Development - IND-enabling studies for IDE251 are progressing as planned, with the company targeting an Investigational New Drug (IND) submission to the FDA in 2025 [5] - The preclinical profile of IDE251 suggests an enriched response in 8p11 amplified cancers, with dual KAT6/7 inhibition showing superior anti-tumor activity compared to KAT6 inhibition alone [3][4] - IDE251 is being developed as a monotherapy for patients with breast and lung cancers with 8p11 amplification, with additional opportunities in lineage addiction settings [4] Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics [6] - The company integrates translational biomarker identification and validation with drug discovery to select patient populations most likely to benefit from its targeted therapies [6] - IDEAYA is applying its research and drug discovery capabilities to synthetic lethality, an emerging class of precision medicine targets [6]

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced agenda topics for its virtual Investor R&D Day. The webcast event will be hosted by IDEAYA on Monday, December 16, 2024 at 8:00 am to 9:30 am ET.The presentations by IDEAYA management and key opinion leaders will showcase scientific insights and clinical development opportunities across IDEAYA' ...

I covered Ideaya Biosciences, Inc. (NASDAQ: IDYA ) in December last year, and the stock had a great run for a while, before returning more or less to its December position. That "idiopathic" bullish run started in early January and continuedAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research ma ...

SOUTH SAN FRANCISCO, Calif., Dec. 2, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations events.Citi's 2024 Global Healthcare ConferenceTuesday, December 3rd, 2024 at 8:00 AM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst7th Annual ...

Brings over 20-year global commercialization experience in oncology with leading biopharmaceutical companies Gilead Sciences and Bristol Myers Squibb, including leadership of multiple commercial launches for products including Trodelvy® and Opdivo®SOUTH SAN FRANCISCO, Calif., Nov. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Stu Dorman as Chief Co ...

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2024 /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 Jefferies London Healthcare Conference and its plans to host an Investor R&D Day in December 2024.Jefferies London Healthcare ConferenceTuesday, November 19th, 2024 at 10:00 AM GMT | 5:00 AM ET Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Maury ...

IDEAYA Biosciences, Inc. (IDYA) closed the last trading session at $30.41, gaining 3.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $55.31 indicates an 81.9% upside potential.The mean estimate comprises 13 short-term price targets with a standard deviation of $10.50. While the lowest estimate of $27 indicates a 11.2% decline from the current price level, the most optimistic ana ...

Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients Successful FDA Type C meeting and targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025; Phase 2 neoadjuvant update with ~49% with >30% ocular tumor shrinkage & ~61% eyes preserved, and over 75 patients enrolled ENA 2024: Late-breaker oral presentation of IDE397 in MTAP-deletion UC and NSCLC with confirmed ORR b ...

Wall Street expects a year-over-year decline in earnings on lower revenues when IDEAYA Biosciences, Inc. (IDYA) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they m ...

Core Insights - IDEAYA Biosciences announced positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM), showing approximately 49% of patients with over 30% tumor shrinkage and a 61% eye preservation rate for enucleation patients [1][2][3] Clinical Trial Data - In the Phase 2 trials, 31 enucleation and 18 plaque brachytherapy evaluable UM patients were treated, with 59% of patients showing over 20% ocular tumor shrinkage and 49% showing over 30% shrinkage [6] - The eye preservation rate observed was 61%, with manageable adverse event (AE) profiles including 11% grade 3 or higher AEs and a 3% discontinuation rate [6] FDA Engagement - A successful FDA Type C meeting has provided a potential registrational path for darovasertib, with primary endpoints of eye preservation and time to vision loss, and no detriment to Event-Free Survival (EFS) as a secondary endpoint [3][9] - Ongoing discussions with the FDA may include Overall Response Rate (ORR) as a potential surrogate endpoint to support earlier approval scenarios [9] Future Trial Plans - IDEAYA plans to initiate a Phase 3 randomized registrational trial in neoadjuvant UM, targeting approximately 400 patients, with two cohorts: enucleation eligible and plaque brachytherapy eligible UM patients [8][9] - The primary endpoint for enucleation patients will be eye preservation rate, while time to vision loss will be the primary endpoint for plaque brachytherapy patients [9] Market Opportunity - The annual incidence of primary UM in North America, Europe, and Australia is projected to be around 12,000 patients, representing a significant market opportunity for darovasertib, as there are currently no FDA-approved therapies for this condition [1][10] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics and integrating capabilities in identifying and validating translational biomarkers [14]