Roche reported two Phase 3 victories for its oral BTK inhibitor fenebrutinib across distinct multiple sclerosis populations, including relapsing and primary progressive forms. One trial met its primary endpoint demonstrating non-inferiority to standard therapy; the other delivered data supporting broader efficacy claims. The results revive momentum for BTK inhibitors after a string of mixed outcomes for the class and set Roche on a path toward regulatory filings for expanded MS indications. Analysts noted the company will need to compile sufficient safety and long-term data before submission. The dossier will be scrutinized for safety signals common to BTK inhibition, but the registrational wins mark a major clinical advance for Roche in neuroimmunology.