Sanofi(US:SNY) Globenewswire·2025-09-22 05:00Core Insights - The FDA has extended the review period for tolebrutinib by three months, with a new target action date set for December 28, 2025, due to the submission of additional analyses [2][4] - Tolebrutinib is the first brain-penetrant BTK inhibitor designated as a breakthrough therapy for non-relapsing, secondary progressive multiple sclerosis (nrSPMS) [3][11] - Sanofi is committed to developing innovative treatments for neurological diseases, with tolebrutinib representing a significant advancement in addressing the underlying causes of disability progression in MS [12][13] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a strong pipeline in neurology and immunoscience [13] - The company emphasizes its commitment to addressing serious neuro-inflammatory and neuro-degenerative conditions, including multiple sclerosis [12][13] Industry Context - Multiple sclerosis is a chronic, immune-mediated neurodegenerative disease that leads to irreversible disabilities, highlighting a significant unmet medical need in the treatment landscape [5] - Current therapies primarily target peripheral B and T cells, while the innate immunity within the CNS, which contributes to disability accumulation, remains largely unaddressed [5][11]