Novartis said its Phase III REMODEL-1 and REMODEL-2 trials showed oral remibrutinib was superior to teriflunomide, marketed by Sanofi as Aubagio, in reducing the annualized relapse rate among patients with relapsing multiple sclerosis, with each study enrolling about 1,000 people. The investigational BTK inhibitor also beat teriflunomide on all key secondary endpoints, including MRI brain lesions, and produced clinically meaningful slowing of disability progression. Novartis reported no liver safety signal across more than 4,500 trial participants and no Hy’s Law cases, a point of differentiation after other BTK inhibitors faced regulatory scrutiny over liver toxicity and after the FDA in December declined to approve Sanofi’s tolebrutinib. Shares gained 4.5% in Tuesday European midday trading, lifting the year-to-date advance to 18%. Two patient deaths in the trials were judged unrelated to the study drug; analysts said they still want fuller safety detail. UBS analyst Matt Weston called remibrutinib at least a best-in-class oral agent. Novartis plans to seek regulatory approval in major markets and present complete data at a Toronto medical conference. Remibrutinib is already approved as Rhapsido for chronic spontaneous urticaria and is positioned to help offset Entresto generic pressure, alongside MS franchise growth such as Kesimpta’s 32% rise to $1.42 billion in the second quarter. Separately, Novartis suspended eight rap-cel CAR-T studies after three patient deaths from severe immune hyperactivation, while two oncology trials continued.