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Servier to Acquire Day One Biopharmaceuticals for ~$2.5B

Shots: Servier has entered into a definitive agreement to acquire Day One Biopharmaceuticals As per the deal, Servier will acquire Day One for $21.5/share in cash, representing the total equity value of ~$2.5B, with remaining shares acquired later via a second-step merger; closing expected in Q2’26 Acquisition will strengthen Servier’s leadership in pediatric low-grade glioma…

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Insilico Medicine and Servier Enter ~$888M R&D Alliance to Advance Novel Oncology Therapies

Shots: Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…

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The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU 

Shots:  The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states   Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…

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IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…

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Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:  The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states  The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

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Servier

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:     The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery  Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…

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VIEWPOINTS_Susan Pandya_2024

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

Shots:  In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile  While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma  With a fast-track designation and breakthrough therapy…

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