Roche reported a third Phase 3 success for its BTK inhibitor fenebrutinib in multiple sclerosis, advancing plans for regulatory filings. The trial hit its primary efficacy endpoint, but investigators observed liver-related adverse events and a numerical imbalance in deaths in the fenebrutinib arm versus control, prompting internal analyses and safety follow‑up. Roche (company release and trial data) is advancing the program while conducting deeper safety assessments; regulators and clinicians will scrutinize hepatic safety as BTK inhibitors expand into neurology. Fenebrutinib’s efficacy readouts strengthen Roche’s late‑stage neurology portfolio, but the mortality and liver findings will shape label language, monitoring recommendations and market adoption.