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Source document· December 24, 2025

Communiqué de presse : Sanofi fait le point sur la soumission réglementaire du tolebrutinib dans la sclérose en plaques secondaire progressive non-récurrente

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Communiqué de presse : Sanofi fait le point sur la soumission réglementaire du tolebrutinib dans la sclérose en plaques secondaire progressive non-récurrente Sanofi fait le point sur la soumission réglementaire du tolebrutinib dans la sclérose en plaques secondaire progressive non-récurrente Paris, le 24 décembre 2025…
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  • Impairment test result will have no impact on net income from activities/earnings per share from activities, and financial guidance for 2025 remains unchanged

    80% confidence

  • FDA's decision represents a significant and important policy reversal from previous feedback the agency had given to Sanofi

    80% confidence

  • Sanofi remains committed to working with FDA to find a path forward for tolebrutinib and ultimately serve the MS patient community

    80% confidence

  • FDA should consider input from scientific experts, clinicians and patients on this matter to ensure all perspectives are considered

    80% confidence

  • Sanofi is very disappointed by FDA's action

    80% confidence

  • Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and achieve long-term growth

    80% confidence

  • Disability progression remains a major unmet medical need in multiple sclerosis

    80% confidence
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Communiqué de presse : Sanofi fait le point sur la soumission réglementaire du tolebrutinib dans la sclérose en plaques secondaire progressive non-récurrente — Source | Via News | ViaNews EU