Roche reported a third positive Phase 3 for fenebrutinib in multiple sclerosis, positioning the BTK inhibitor for regulatory submissions. The drug hit its primary efficacy endpoints across relapsing forms of MS in the newly reported trial. However, the study also recorded liver‑related adverse events and more deaths in the fenebrutinib arm than in control, prompting safety reviews and investor scrutiny. Roche must reconcile the efficacy results with the mortality signal as it prepares regulatory filings. The juxtaposition of robust Phase 3 efficacy and concerning safety findings will shape Roche’s discussions with regulators and payers, and may influence label language, monitoring requirements and market uptake timelines.