Novartis Reports Positive Results from Late-stage Studies for Remibrutinib

Novartis reported positive Phase III trial results for remibrutinib, showing 31–35% reduction in MS relapses and a 29.2% reduction in disability progression. The drug demonstrated a favorable safety profile compared to teriflunomide, with lower liver enzyme elevations and fewer adverse event discontinuations. Novartis positions remibrutinib as a potential new treatment for relapsing multiple sclerosis (RMS).

Novartis reported a 19.1% reduction in death risk for early breast cancer patients treated with Kisqali (ribociclib) plus endocrine therapy, per six-year NATALEE trial data. Benefits included a 5.3% invasive disease-free survival increase and a 2.1% overall survival difference. The findings support Kisqali's role in treating high-risk early breast cancer, according to Novartis and trial investigators.

Novartis' remibrutinib showed 31.2% to 35.2% lower annualized relapse rates vs. teriflunomide in two late-stage MS trials. Both trials met primary endpoints. Novartis plans global regulatory filings. Analysts estimate potential peak sales over $4B, though not company guidance.

Novartis' remibrutinib showed a 30% reduction in disability progression in a Phase III trial for multiple sclerosis (MS). The drug also increased the proportion of patients with no evidence of disease activity. Novartis estimates a $4B opportunity for remibrutinib in relapsing MS. The company reported no major safety differences compared to teriflunomide. Novartis is conducting additional studies, with results expected in 2028 and 2031.

Novartis reported that Kisqali (ribociclib) plus endocrine therapy reduced death risk by 19.1% in a six-year study of early breast cancer. The trial showed a 2.1 percentage point overall-survival difference at year six. No new safety concerns were identified. The data will be presented at the 2026 ESMO Congress.

Novartis' remibrutinib, an oral BTK inhibitor, reduced annualized relapse rate by 35.2% and 31.2% in two phase 3 trials for relapsing multiple sclerosis (RMS) compared to teriflunomide. The trials also showed improvements in disability progression and MRI outcomes. Novartis plans to seek global regulatory approval for remibrutinib in RMS.