The FDA decision on Sanofi’s (SNY) New Drug Application for Tolebrutinib, which is under priority review, is due on September 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.Roche’s Ocrevus and Novartis’ Kesimpta are some of the rival drugs to Tolebrutinib.GlobalData forecasts that Tolebrutinib could generate approximately $2.6 billion in annual sales by 2030 across the seven major markets.SNY closed Wednesday’s (Aug.27, 2025) trading at $50.11, down 0.38%.