Novartis remibrutinib shows positive Phase III results for multiple sclerosis

Novartis announced positive topline results from two Phase III trials, REMODEL-1 and REMODEL-2, for its experimental oral drug remibrutinib in treating relapsing multiple sclerosis. The drug, a Bruton’s tyrosine kinase (BTK) inhibitor, met its primary endpoint by significantly reducing annualized relapse rates compared to the active comparator, teriflunomide.

In addition to reducing relapses, remibrutinib demonstrated superiority in key secondary endpoints, including a reduction in MRI-detected inflammatory brain lesions and a clinically meaningful delay in disability progression. The company reported a favorable safety profile with no observed liver toxicity signals.

Following the announcement, Novartis shares rose significantly, hitting an all-time high. Analysts suggest the drug has substantial commercial potential, with some estimating peak sales could exceed $3 billion. Novartis plans to seek regulatory approval globally and will present full data at the MS Toronto 2026 congress.