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IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2025 for Phase 2 Clinical Trial of Neoadjuvant Darovasertib in Primary Uveal Melanoma

1. Darovasertib gains FDA Breakthrough Therapy Designation for neoadjuvant uveal melanoma. 2. Phase 2 study results will be presented at ESMO 2025 in Berlin. 3. Multisite Phase 3 trial for darovasertib initiated in Q3 2025. 4. Clinical data expected to impact disease management and patient outcomes.

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FAQ

Why Bullish?

FDA designation often leads to increased investor confidence. Historical examples show FDA designations boost stock values notably.

How important is it?

The announcement of FDA breakthrough status and ongoing trials signify critical progress for IDYA.

Why Long Term?

FDA approvals can take time but significantly enhance long-term growth potential. The initiation of Phase 3 trials further supports sustained interest.

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The presentation will include data from over 90 patients in both the plaque brachytherapy and enucleation-eligible cohorts Darovasertib has received U.S. FDA Breakthrough Therapy Designation for use in neoadjuvant uveal melanoma for subjects requiring enucleation Initiated a multi-site, global randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma (OptimUM-10) in Q3 2025 , /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced that results from a multi-site global Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma was accepted for a Proffered Paper oral presentation at the 2025 European Society of Medical Oncology (ESMO) meeting, taking place on October 17-21 in Berlin, Germany. A summary of the data from the abstract will be shared at a future date.  "We are excited to share clinical data at ESMO 2025 on the effects of neoadjuvant darovasertib in primary uveal melanoma across both plaque brachytherapy and enucleation cohorts. Its potential to impact the natural history of this disease and its management will be highlighted in the presentation. We continue to advance our clinical strategy for darovasertib in earlier stage disease, with the recent initiation of a randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma," said Dr. Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences. Details of the Proffered Paper Oral Presentation are as follows: Title (Abstract #5053): Enucleation prevention and vision preservation in primary uveal melanoma (UM): preliminary results from a phase 2 study of neoadjuvant darovasertib Presenter: Dr. Marcus Butler, MD, Associate Professor, Princess Margaret Cancer Center at the University of Toronto About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small-molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of improving clinical outcomes for patients with cancer.  Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of darovasertib, and (ii) the timing and content of a presentation on the preliminary results from a Phase 2 study of neoadjuvant darovasertib in primary UM. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA BiosciencesJoshua Bleharski, Ph.D.Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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