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Roche’s Oral BTK Drug Succeeds in Phase 3 MS Trials, Matching Ocrevus in Progressive Disease

Full relapsing data remain pending until a second trial reports in 2026.

Overview

  • Fenebrutinib significantly reduced annual relapse rates versus teriflunomide (Aubagio) over 96 weeks in a Phase 3 relapsing multiple sclerosis study.
  • In a separate ~1,000‑patient primary progressive MS trial, the oral BTK inhibitor was non‑inferior to Ocrevus at delaying confirmed disability progression.
  • The primary progressive study followed participants for at least 120 weeks and used a composite endpoint assessing walking speed, arm function and overall disability.
  • Safety remains a focus for the BTK class given prior FDA partial holds and liver injury concerns, with Roche reporting liver safety consistent with earlier studies.
  • Shares of Roche rose roughly 3% as TG Therapeutics fell more than 5%, reflecting competitive pressure on Briumvi from a potential high‑efficacy oral option.