Novartis' oral BTK inhibitor beats Aubagio in Phase III multiple sclerosis trials, shares jump nearly 6%

Novartis said its oral BTK inhibitor remibrutinib, already approved as Rhapsido for chronic hives, met the primary endpoint in two Phase III trials for relapsing multiple sclerosis, according to a Form 6-K filing. The REMODEL-1 and REMODEL-2 studies enrolled roughly 2,000 patients worldwide and showed remibrutinib significantly reduced the annualized relapse rate compared with teriflunomide, sold by Sanofi as Aubagio and the existing oral standard of care for the disease.

Novartis said remibrutinib also beat teriflunomide on every key secondary endpoint within each trial, including a reduction in MRI-visible brain lesions, and showed a positive trend on slowing disability progression, with a nominally significant result on the six-month measure in a preplanned combined analysis. The company reported no liver-safety signal and no cases meeting the regulatory Hy's Law criteria, a safety profile it said was consistent with what has been seen in remibrutinib's existing hives indication.

NVS shares rose nearly 6% on the day the results were announced, among the stock's larger single-day moves this year, as investors weighed remibrutinib's potential to become a new oral multiple sclerosis treatment and a follow-on to Novartis' existing Kesimpta franchise. Media coverage of the announcement, including the Wall Street Journal, framed the rally around the trial's clean efficacy and safety readout rather than any new analyst rating action; SentiSense did not find a formal analyst upgrade or downgrade tied to the news in the days around the release.

Novartis said it intends to pursue global regulatory approval for remibrutinib in relapsing multiple sclerosis and will present the complete trial data at an upcoming medical conference in Toronto. The MS program is one of several closely watched late-stage Novartis pipeline readouts this year, and the company has pointed to remibrutinib as a candidate that could meaningfully expand its neurology and immunology business beyond the existing Kesimpta and hives franchises.

Investors will next watch how the full dataset holds up when presented in Toronto, whether disability-progression results strengthen with longer follow-up, and how quickly Novartis can move through global regulatory filings for the new indication. Competing oral therapies in multiple sclerosis continue to advance as well, so the durability of remibrutinib's edge over teriflunomide could narrow once head-to-head data accumulates over time.

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