Ipsen Receives European Green Light for Pediatric Brain Tumor Treatment
The European Commission has granted conditional marketing authorization to Ipsen's Ojemda (tovorafenib) for treating children with pediatric low-grade gliomas presenting a BRAF alteration and having progressed after previous treatments. This approval applies to the 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
The European Commission's authorization is based on data from the phase II pivotal FIREFLY-1 study, which evaluated tovorafenib in 137 children and young adults with pediatric low-grade gliomas with BRAF alteration, who were relapsed or refractory, having received at least one prior systemic treatment. Tovorafenib is a type II RAF kinase inhibitor targeting mutated BRAF V600, wild-type BRAF, and wild-type CRAF. It acts on signaling pathways that regulate cell growth and division.
Impact on Pediatric Low-Grade Glioma Patients
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Over 800 children are diagnosed each year with pediatric low-grade glioma presenting a BRAF alteration in the European Union. Although classified as a slow-progressing low-grade tumor, this disease imposes a significant lifelong burden, often leading to severe physical and neurological impairments, including loss of vision, speech disorders, and motor dysfunctions. Until now, many affected children have had to undergo invasive surgeries, multiple lines of chemotherapy, and radiotherapy, often associated with long-term health complications. Sandra Silvestri, Executive Vice President and Chief Medical Officer at Ipsen, stated that 'the priority now is to ensure as rapid access as possible to this treatment for eligible children across Europe.'
"En 2025, Ipsen a enregistré une croissance solide de son chiffre d'affaires et de son résultat opérationnel."
Ipsen a publié ses résultats 2025 et T4 2025: chiffre d'affaires de 3 675,9 millions d'euros, croissance YoY de 8,1%; Résultat opérationnel des activités de 1 294,1 millions d'euros, marge de 35,2%; Résultat net consolidé IFRS de 444,5 millions d'euros; Bénéfice dilué par action IFRS de 5,32 euros; Cash-flow libre de 1 000,6 millions d'euros; Dividende par action de 1,40 euro.
Outlook / guidance
Expected revenue: Une croissance des ventes totales supérieure à 13,0 % à taux de change constant en 2026
Management commentary: Ipsen prévoit en 2026 une croissance des ventes totales supérieure à 13,0% à taux de change constant et une marge opérationnelle des activités supérieure à 35,0%.
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