Roche announced two positive registrational Phase 3 readouts for its BTK inhibitor fenebrutinib across different forms of multiple sclerosis. The Swiss drugmaker said one study met its primary endpoints and a second showed outcomes that support regulatory filings; the wins are notable after a string of setbacks for BTK programs. Company statements and trial data presentations indicate fenebrutinib achieved non‑inferiority or superiority versus established comparators in key measures of relapse and MRI activity. The results were framed as clearing the path toward submission in multiple MS indications; Roche cited safety and efficacy datasets from the two trials. BTK inhibitors target B‑cell and myeloid signaling implicated in MS pathogenesis—an immune‑modulating mechanism distinct from anti‑CD20 antibodies. Regulators and competitors will watch safety profiles closely given prior tolerability concerns for the class.