Roche reported another positive Phase 3 readout for its oral BTK inhibitor fenebrutinib in multiple sclerosis, clearing primary efficacy endpoints across indications. However, the study also recorded liver‑related adverse events, including fatal outcomes in a subset of participants, prompting questions about benefit–risk and regulatory review. Fenebrutinib’s third pivotal win strengthens Roche’s efficacy dossier for relapsing forms of MS, but the company acknowledged the need for deeper safety analyses and post‑hoc evaluations of hepatic events. Regulators will likely weigh the aggregate survival and safety data before any approval decision. BTK inhibitors modulate B‑cell and innate immune signaling and are under intense regulatory scrutiny for idiosyncratic organ toxicities; Roche said it will provide detailed datasets to health authorities as it prepares submissions.