Roche reported a second phase 3 success for fenebrutinib in relapsing multiple sclerosis, with the trial hitting its primary endpoint and strengthening the company’s regulatory case for the BTK inhibitor. However, an imbalance in on‑study deaths compared with control arms emerged, prompting further safety analyses by Roche. The company said it will provide additional data to regulators and investigators as part of ongoing evaluation. The deaths have raised new scrutiny of fenebrutinib’s safety profile despite efficacy on relapse endpoints. Regulators and clinicians will weigh the benefit‑risk calculus for a new oral BTK option in MS. Roche must reconcile efficacy with the mortality findings before advancing global approval plans.