Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide
IDEAYA Biosciences (NASDAQ: IDYA) has entered into an exclusive license agreement with Servier for darovasertib, a potential first-in-class treatment for uveal melanoma, a rare and aggressive eye cancer. Under the agreement, IDEAYA will receive $210 million upfront and up to $320 million in milestone payments, plus double-digit royalties on net sales.
The partnership grants Servier regulatory and commercial rights for darovasertib outside the United States, while IDEAYA retains U.S. rights. The drug, which has received FDA Breakthrough Therapy and Fast Track designations, is being evaluated in multiple global clinical trials, including three Phase 3 registrational trials targeting neoadjuvant, adjuvant, and metastatic settings.
IDEAYA Biosciences (NASDAQ: IDYA) ha stipulato un accordo di licenza esclusiva con Servier per darovasertib, un potenziale trattamento di prima classe per il melanoma uveale, un tumore oculare raro e aggressivo. Nell'ambito dell'intesa, IDEAYA riceverà 210 milioni di dollari upfront e fino a 320 milioni di dollari in pagamenti legati a milestone, oltre a royalty a doppia cifra sulle vendite nette.
La partnership conferisce a Servier i diritti regolatori e commerciali per darovasertib al di fuori degli Stati Uniti, mentre IDEAYA mantiene i diritti per il mercato statunitense. Il farmaco, che ha ottenuto le designazioni FDA Breakthrough Therapy e Fast Track, è in valutazione in più studi clinici globali, inclusi tre studi registrativi di Fase 3 rivolti agli ambiti neoadiuvante, adiuvante e metastatico.
IDEAYA Biosciences (NASDAQ: IDYA) ha firmado un acuerdo de licencia exclusiva con Servier para darovasertib, un posible tratamiento pionero para el melanoma de la úvea, un cáncer ocular raro y agresivo. Según el acuerdo, IDEAYA recibirá 210 millones de dólares por adelantado y hasta 320 millones de dólares en pagos por hitos, además de regalías de dos dígitos sobre las ventas netas.
La alianza otorga a Servier los derechos regulatorios y comerciales de darovasertib fuera de Estados Unidos, mientras que IDEAYA conserva los derechos en EE. UU. El fármaco, que ha recibido las designaciones FDA Breakthrough Therapy y Fast Track, se está evaluando en varios ensayos clínicos globales, incluidos tres ensayos registratorios de Fase 3 dirigidos a los escenarios neoadyuvante, adyuvante y metastásico.
IDEAYA Biosciences (NASDAQ: IDYA)가 우베알(포도막) 흑색종이라는 희귀하고 공격적인 안구암 치료를 위한 잠재적 1호(First-in-class) 치료제인 다로바서티브(darovasertib)에 대해 Servier와 독점 라이선스 계약을 체결했습니다. 계약에 따라 IDEAYA는 2억 1천만 달러의 선지급금을 받게며 최대 3억 2천만 달러의 마일스톤 지급과 순매출에 대한 두 자릿수 로열티를 받습니다.
이번 파트너십으로 Servier는 미국을 제외한 지역에서 다로바서티브의 규제·상업화 권리를 얻고, IDEAYA는 미국 내 권리를 유지합니다. FDA의 Breakthrough Therapy 및 Fast Track 지정도 받은 이 약물은 신보조(네오아주번트), 보조(아주번트), 전이성 등 다양한 임상 상황을 목표로 한 세 건의 3상 등록 임상시험을 포함해 다수의 글로벌 임상시험에서 평가 중입니다.
IDEAYA Biosciences (NASDAQ: IDYA) a conclu un accord de licence exclusive avec Servier pour le darovasertib, un traitement potentiel de première classe contre le mélanome uvéal, un cancer de l'œil rare et agressif. Dans le cadre de l'accord, IDEAYA recevra 210 millions de dollars en paiement initial et jusqu'à 320 millions de dollars en paiements liés à des jalons, ainsi que des redevances à deux chiffres sur les ventes nettes.
Le partenariat accorde à Servier les droits réglementaires et commerciaux pour le darovasertib en dehors des États-Unis, tandis qu'IDEAYA conserve les droits sur le marché américain. Le médicament, qui a obtenu les désignations FDA Breakthrough Therapy et Fast Track, est évalué dans plusieurs essais cliniques mondiaux, y compris trois essais d'enregistrement de phase 3 visant les contextes néoadjuvant, adjuvant et métastatique.
IDEAYA Biosciences (NASDAQ: IDYA) hat eine exklusive Lizenzvereinbarung mit Servier für Darovasertib abgeschlossen, einen potenziellen First-in-Class-Wirkstoff zur Behandlung des uvealen Melanoms, eines seltenen und aggressiven Augenkrebses. Im Rahmen der Vereinbarung erhält IDEAYA 210 Millionen US-Dollar als Upfront-Zahlung und bis zu 320 Millionen US-Dollar an Meilensteinzahlungen sowie zweistellige Royalties auf den Nettoumsatz.
Die Partnerschaft räumt Servier die regulatorischen und kommerziellen Rechte an Darovasertib außerhalb der Vereinigten Staaten ein, während IDEAYA die US-Rechte behält. Das Medikament, das von der FDA als Breakthrough Therapy und Fast Track eingestuft wurde, wird in mehreren globalen klinischen Studien geprüft, darunter drei Phase‑3‑Registrierungsstudien für neoadjuvante, adjuvante und metastatische Einsatzgebiete.
- None.
- Development costs will be shared between both companies
- IDEAYA gives up rights to commercialize outside the U.S.
- Phase 2/3 trial results not expected until late 2025 or Q1 2026
Insights
IDEAYA's $210M deal with Servier for darovasertib significantly strengthens its financial position while expanding global access for uveal melanoma patients.
This licensing agreement represents a substantial financial boost for IDEAYA Biosciences, securing an immediate
The partnership creates a capital-efficient development pathway for darovasertib through cost-sharing arrangements for ongoing clinical trials. This includes three Phase 3 registrational trials targeting different treatment settings (neoadjuvant, adjuvant, and metastatic) for uveal melanoma—a rare eye cancer with limited treatment options. The shared development costs will significantly reduce IDEAYA's burn rate while accelerating the global clinical program.
From a regulatory perspective, darovasertib has already received FDA Breakthrough Therapy Designation for neoadjuvant therapy and Fast Track designation in combination with crizotinib for metastatic uveal melanoma. These designations, along with its Orphan Drug status, highlight the drug's potential to address critical unmet needs and may expedite its path to market.
The upcoming data readout for the Phase 2/3 trial (expected between year-end 2025 and Q1 2026) represents a crucial near-term catalyst. Positive progression-free survival results could significantly enhance darovasertib's commercial prospects and trigger milestone payments. This deal transforms IDEAYA's financial trajectory, extending its cash runway while maintaining significant upside through US commercialization rights and milestone/royalty income from global markets.
- 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 $320 million - IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs
SURESNES, France and
"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
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
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
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
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
Headquartered in
More information on: servier.com. Follow us on social media: LinkedIn, Facebook, X, Instagram.
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/servier-and-ideaya-biosciences-partner-to-bring-darovasertib-a-promising-uveal-melanoma-treatment-to-patients-worldwide-302543276.html
SOURCE IDEAYA Biosciences, Inc.
FAQ
What are the financial terms of the IDYA and Servier partnership for darovasertib?
What is the market potential for IDYA's darovasertib?
When will IDYA's darovasertib Phase 2/3 trial results be available?
What territories does the IDYA-Servier partnership cover for darovasertib?
How many clinical trials is IDYA conducting for darovasertib?
