The FDA decision on Sanofi's (SNY) New Drug Application for Tolebrutinib is expected to be announced on December 28, 2025.Tolebrutinib, an investigational, oral, brain-penetrant, and bioactive Bruton's tyrosine kinase (BTK) inhibitor, is proposed for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.If approved, Tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity. Tolebrutinib will face competition from Roche's Ocrevus and Novartis' Kesimpta if it reaches the pharmacy shelves.GlobalData forecasts that Tolebrutinib has the potential to generate roughly $2.6 billion in annual sales by 2030 across the seven major markets.SNY closed Wednesday’s (November 26, 2025) trading at $50.03, down 0.50%.