Roche reported a third positive Phase 3 trial for fenebrutinib in multiple sclerosis, meeting primary endpoints, but the studies revealed a concerning liver safety signal and an imbalance in deaths on the active arm. The company plans regulatory submissions but has launched additional analyses to address the mortality and hepatic adverse events. Investors and regulators are weighing efficacy against safety; analysts note the drug’s commercial potential as an oral BTK inhibitor but warn that liver‑related risks could complicate labeling, post‑marketing commitments or approval timing. Roche has signaled further investigation into the causes of the events while preparing filings.