Peptide News Digest

#Remibrutinib

2 stories

Industry · View digest

Novartis Reports 4%+ Share Gain Following Tuesday REMODEL RMS Phase 3 Win; Focus Turns to Pacibekitug IL-6 Phase 3 Advance and Avidity RNAi Neuromuscular Integration

Novartis (NYSE: NVS) shares rose more than 4% Tuesday September 1 and continued climbing Wednesday September 2, 2026 following the twin REMODEL-1 and REMODEL-2 Phase 3 wins of remibrutinib (an oral BTK inhibitor) in relapsing multiple sclerosis, which met both primary endpoints versus teriflunomide with a clean liver-safety profile across the 4,500+ patient program. Investor focus now turns to two additional Novartis growth-vehicle programs: pacibekitug (an anti-IL-6 monoclonal antibody acquired in the $1.4 billion Tourmaline Bio acquisition earlier in 2026) advancing into Phase 3 for cardiovascular risk reduction despite Novo Nordisk's ZEUS ziltivekimab Phase 3 miss at ESC 2026 last weekend; and the ongoing integration of the $12 billion Avidity Biosciences acquisition centered on RNAi drug delivery to muscle tissue for facioscapulohumeral muscular dystrophy, DM1 myotonic dystrophy, and Duchenne muscular dystrophy programs. Novartis Q3 2026 earnings release is scheduled for late October.

Clinical Trials · View digest

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.