Novartis Remibrutinib Meets Both Primary Endpoints in Twin REMODEL-1 and REMODEL-2 Phase 3 Trials for Relapsing Multiple Sclerosis; Clean Liver-Safety Profile Across 4,500+ Patient Program
Novartis (NYSE: NVS) announced Tuesday September 1, 2026 that the twin REMODEL-1 and REMODEL-2 Phase 3 trials of remibrutinib (an oral, selective, high-efficacy Bruton's tyrosine kinase inhibitor) met both primary endpoints in relapsing multiple sclerosis, with remibrutinib demonstrating statistically significant superiority versus teriflunomide (Aubagio) in reducing annualized relapse rate (ARR) and inflammatory brain MRI lesions. Key secondary endpoints related to disability progression trended in favor of remibrutinib, with nominal significance in 6-month confirmed disability progression (6mCDP) in a preplanned pooled analysis. Safety was clean: no liver-safety signal and no cases meeting Hy's Law criteria across a broader remibrutinib development program that has now enrolled more than 4,500 participants across neurologic and immune-mediated indications. Full REMODEL-1/-2 data will be presented at MSToronto2026 (ECTRIMS-ACTRIMS joint meeting, October 21-23, Toronto). Regulatory submissions will follow. The readout positions remibrutinib as a potential oral option in a category currently anchored by injectable anti-CD20 therapies (Ocrevus, Kesimpta, Briumvi) plus Sanofi's Aubagio and the sphingosine-1-phosphate receptor modulators.