Roche reported a third positive Phase 3 readout for its BTK inhibitor fenebrutinib in multiple sclerosis but acknowledged a safety signal: a higher number of deaths in the fenebrutinib arm relative to control in the trial dataset. The company said it will present detailed analyses to regulators as it advances an approval filing. Analysts noted that the efficacy result strengthens Roche’s MS franchise prospects, but the liver‑related adverse events and unexplained mortality require regulator scrutiny and could complicate labeling, risk‑management plans and commercial uptake. The outcome underscores the tension between robust efficacy and off‑target safety in systemic small‑molecule immunomodulators.