Novartis remibrutinib meets phase 3 MS endpoints

Novartis reports positive Phase 3 results for remibrutinib, its oral BTK inhibitor, in relapsing multiple sclerosis, with REMODEL-1 and REMODEL-2 showing superior reduction in annualized relapse rate and other key outcomes compared with Aubagio. The trials also indicated reduced MRI lesion burden and a potential delay in disability progression, reinforcing the drug’s broader development trajectory beyond its existing approval for chronic spontaneous urticaria. Based on these findings, Novartis plans to file for regulatory approval of remibrutinib in relapsing MS worldwide, aiming to expand its blockbuster potential alongside other pipeline assets. The company emphasized a consistent safety profile with no liver safety signals, supporting optimism about long-term use. Remibrutinib, already marketed as Rhapsido for CSU in the US, EU, and Japan, is being positioned as a major growth driver with sales forecasts ranging from several billion dollars. Investors reacted positively, with the stock trading higher following the trial news, and Novartis preparing for late-breaking presentations at MSToronto2026 to share further details.