• Servier and IDEAYA Biosciences enter into an exclusive license agreement for regulatory and commercial rights to darovasertib outside the US
• Darovasertib is a small molecule developed for patients with uveal melanoma, a rare type of eye cancer with high unmet medical need
• IDEAYA will receive an upfront payment of $210 million and up to $320 million in regulatory and commercial milestones, plus double-digit royalties on net sales
• IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs

SURESNES, France and SOUTH SAN FRANCISCO, Calif., Sept. 2, 2025 /PRNewswire/ -- Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide. Under the agreement, Servier obtains the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA retains its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

"At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide," said Arnaud Lallouette, Executive Vice-President Global Medical & Patient Affairs at Servier. "Today, there are limited treatment options and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network, and expertise in developing oncology targeted therapies, to make this groundbreaking treatment accessible to patients across the globe."

"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development for darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. 

"We believe Servier's global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the U.S. will ensure that this potentially life-changing treatment reaches as many patients as possible," said Daniel Simon, Chief Business Officer, IDEAYA Biosciences.

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial evaluating darovasertib in combination with crizotinib in first line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomized trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumor, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million, and be eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.

Servier Contact

Olympe Muller
olympe.muller@servier.com

IDEAYA Biosciences Contact

Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com  

About Servier

Servier is an independent international pharmaceutical company governed by a nonprofit foundation, committed to making a meaningful social impact on patients and contributing to a sustainable world. Its unique governance model ensures its independence, while supporting long-term innovation, with 100% of its profits reinvested in the Group's development.

As a world leader in hypertension and venous diseases and a major player in cardiometabolism, Servier drives transformative innovation to support patients with chronic conditions and improve their day-to-day lives through a holistic approach, which includes making patient adherence and control a priority across the globe. Its ambition is to become a leading player in rare cancers, which is why the Group invests heavily in oncology, allocating close to 70% of its R&D budget to this field. By leveraging precision medicine, Servier develops therapies that are more targeted and more effective.

Bolstered by its success in oncology, Servier has expanded into neurology, a key driver of future growth. The Group is focused on a select number of neurological diseases, where accurate patient profiling enables targeted therapeutic responses through precision medicine.

To open up wider access to high-quality, affordable care, Servier also offers an extensive range of generic medicines, building on well-established brands in France, Eastern Europe, and Brazil. In all its activities, and at every stage of the medicine life cycle, the Group integrates the patient's voice.

Headquartered in France, Servier operates in close to 140 countries. In 2023-2024, the Group, which employs over 22,000 people worldwide, achieved revenues of €5.9 billion.

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About IDEAYA

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Their approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. IDEAYA has built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Their mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and 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 expected benefits and opportunities related to the licensing agreement; (ii) IDEAYA's right to receive any upfront payment, milestone payments, royalties and costs and reimbursement for clinical trials; (iii) plans for development and commercialization of darovasertib; (iv) the timing and pace of developing darovasertib in clinical trials and the timing of data readouts; (v) the potential therapeutic benefits of darovasertib, including in combination with crizotinib; (vi) the safety profile of darovasertib; and (vii) market opportunities for darovasertib. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, commercialization of products, 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' in early or late 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 the manufacturing or commercialization of drug products, the outcome of pricing, coverage and reimbursement negotiations with third-party payors for IDEAYA's 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. Neither Breakthrough Therapy nor Orphan Drug designations necessarily translates into approval of the drug. 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.

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SOURCE IDEAYA Biosciences, Inc.