Roche reported additional Phase 3 successes for fenebrutinib across multiple sclerosis indications, positioning the BTK inhibitor for regulatory submissions. However, trials flagged liver‑related adverse events and a higher number of on‑study deaths versus comparator arms, prompting Roche to undertake deeper safety analyses and prepare additional data for regulators. The mixed readouts leave questions about benefit‑risk balance and may complicate approval timelines and label language pending further investigation.