Novartis’s MS pill beats a rival in two late-stage trials
Signals InboxSeptember 2, 2026Biopharma
Novartis's oral BTK inhibitor remibrutinib beat teriflunomide in two Phase 3 multiple-sclerosis trials, reducing relapses and MRI lesions with a favorable safety profile. The result matters because the BTK class has suffered development setbacks, and a successful oral entrant could reshape treatment between older pills and high-efficacy infused therapies.
Novartis shares rose after the drugmaker reported positive results in two late-stage trials from its new pill for the most common form of multiple sclerosis. https://t.co/gF9KNBgKOr
— The Wall Street Journal (@WSJ) September 1, 2026
Q1What did Novartis officially report?
Novartis's official release says both REMODEL Phase 3 trials met their primary endpoint and showed remibrutinib was superior to teriflunomide on annualized relapse rate.
Q2What else improved?
The trials also showed superiority on key secondary measures including inflammatory MRI lesions, while pooled analysis showed a clinically meaningful signal on disability progression.
Q3Why does safety matter for BTK inhibitors?
Other BTK programs have faced liver and efficacy problems. Novartis says remibrutinib showed no liver safety signal and no cases meeting Hy's Law criteria across the trials.
Q4Is remibrutinib already approved for anything?
Yes. The molecule is already used in chronic spontaneous urticaria in some markets, giving Novartis a broader safety database of more than 4,500 trial participants across indications.
Q5What happens next?
Novartis plans global regulatory submissions after presenting detailed data. If approved, remibrutinib would test whether patients and physicians prefer a high-efficacy oral therapy over more burdensome infused or injected options.