Novartis has reported positive topline results from two pivotal Phase III studies showing that oral Bruton’s tyrosine kinase inhibitor remibrutinib significantly reduced relapse rates in adults with relapsing multiple sclerosis compared with teriflunomide. Both REMODEL-1 and REMODEL-2 met their primary endpoint independently, while remibrutinib also demonstrated superiority across all key secondary endpoints within each study, including measures of inflammatory brain lesions on magnetic resonance imaging. The company plans global regulatory submissions after presenting detailed results at MSToronto2026.
The readout positions remibrutinib as another serious contender in an increasingly competitive BTK inhibitor race in multiple sclerosis. Importantly, Novartis also reported no liver safety signal and no cases meeting Hy’s Law criteria across the two studies, an observation that could become central to remibrutinib’s eventual clinical positioning given safety concerns associated with some other agents in the class. Exact annualized relapse-rate figures have not yet been disclosed, making the upcoming full presentation necessary before the magnitude of the efficacy advantage can be assessed against competing late-stage therapies.
REMODEL-1 and REMODEL-2 deliver consistent Phase III efficacy across relapsing multiple sclerosis
REMODEL-1 and REMODEL-2 are identical randomized, double-blind, active-comparator Phase III trials evaluating remibrutinib against teriflunomide in adults with relapsing multiple sclerosis. Approximately 2,000 patients globally were randomized between the two studies, with participants required to have recent disease activity and Expanded Disability Status Scale scores ranging from zero to 5.5.
Patients received remibrutinib 100 milligrams or teriflunomide during a double-blind core period lasting up to 30 months, followed by an open-label extension that can continue for as long as five years. Annualized relapse rate served as the primary endpoint, while major secondary measures included three-month and six-month confirmed disability progression, new or enlarging T2 lesions, gadolinium-enhancing T1 lesions, serum neurofilament light chain and the proportion of patients achieving no evidence of disease activity.
Novartis said remibrutinib significantly reduced annualized relapse rate compared with teriflunomide in both trials and was superior across all key secondary endpoints evaluated within each individual study. The company specifically highlighted reductions in inflammatory magnetic resonance imaging lesions, suggesting that the effect extended beyond clinically observed relapses to radiographic disease activity.
The disability findings require a more measured interpretation. In a prespecified pooled analysis of the two studies, remibrutinib produced a positive trend toward reducing three-month confirmed disability progression and achieved nominal statistical significance for six-month confirmed disability progression. Because Novartis has not yet released numerical hazard ratios or detailed statistical results, the extent of that benefit cannot currently be independently evaluated.
That distinction will matter when the complete dataset is presented. Preventing relapses remains an important treatment objective in relapsing multiple sclerosis, but the competitive bar has increasingly shifted toward therapies capable of also limiting disability accumulation while maintaining tolerability suitable for long-term treatment.
Absence of a liver safety signal could help distinguish remibrutinib within the BTK inhibitor class
Remibrutinib inhibits Bruton’s tyrosine kinase, a signaling protein involved in activation of B cells and innate immune cells. By targeting BTK, Novartis aims to influence immune mechanisms driving both peripheral inflammation and neuroinflammation associated with multiple sclerosis.
The company reported that the safety profile in REMODEL-1 and REMODEL-2 remained consistent with experience from a remibrutinib clinical-development program involving more than 4,500 participants across several diseases. Novartis specifically said there was no liver safety signal and no cases meeting Hy’s Law criteria in the multiple sclerosis trials.
That observation could prove strategically important. Sanofi’s tolebrutinib has validated BTK inhibition as a meaningful multiple sclerosis mechanism after receiving European approval for non-relapsing secondary progressive multiple sclerosis, but drug-induced liver injury is an identified safety risk that requires liver monitoring. Tolebrutinib also received a Complete Response Letter from the United States Food and Drug Administration in December 2025 for its non-relapsing secondary progressive multiple sclerosis application.
Roche is another formidable competitor. Its fenebrutinib Phase III FENhance studies reduced annualized relapse rates by 51.1% and 58.5% compared with teriflunomide in relapsing multiple sclerosis, with positive trends toward reducing disability progression. Roche plans regulatory submissions based on a broader program that also produced a positive Phase III result in primary progressive multiple sclerosis.
The competitive landscape means Novartis will need more than statistical significance. The undisclosed magnitude of relapse reduction, disability data, magnetic resonance imaging outcomes, treatment discontinuations and longer-term safety will determine whether remibrutinib can establish a differentiated place beside existing injectable high-efficacy therapies and emerging oral BTK inhibitors.
Existing Rhapsido approval gives Novartis commercial and safety experience with remibrutinib
Remibrutinib is not an entirely new molecular entity for Novartis. The drug is already marketed as Rhapsido for chronic spontaneous urticaria after receiving United States Food and Drug Administration approval in September 2025 and European Commission approval in April 2026.
That existing approval gives Novartis manufacturing, physician and post-marketing experience with the molecule before any potential multiple sclerosis launch. The currently approved chronic spontaneous urticaria regimen uses 25 milligrams twice daily, while the REMODEL studies evaluated a higher 100-milligram regimen in multiple sclerosis. The regulatory review will therefore still need to evaluate the disease-specific efficacy and safety profile associated with the higher dose and longer treatment expectations.
Multiple sclerosis would also represent a substantially different commercial opportunity. Nearly three million people worldwide live with multiple sclerosis, and relapsing disease is the most common form. Yet the field already contains numerous disease-modifying options across oral, injectable and infused modalities, creating a much higher competitive threshold than exists in chronic spontaneous urticaria.
Novartis already has an established multiple sclerosis franchise through Kesimpta, an anti-CD20 therapy for relapsing forms of the disease. Kesimpta generated $1.424 billion in second-quarter 2026 sales, up 32% at constant currencies, and $2.588 billion during the first half. The rapid growth demonstrates both Novartis’ commercial strength in multiple sclerosis and the challenge facing remibrutinib, since a new oral therapy would be entering a portfolio that already contains one of the company’s fastest-growing products.
The two treatments could ultimately address different patient preferences. Kesimpta is a high-efficacy monthly subcutaneous therapy, while remibrutinib could offer an oral alternative for patients seeking strong disease control without injections. How physicians balance efficacy, safety, convenience and monitoring requirements will determine whether remibrutinib expands Novartis’ multiple sclerosis franchise or partly shifts patients within it.
Novartis shares jump as investors assign value to a successful late-stage neuroscience catalyst
Investors reacted strongly to the REMODEL announcement. Novartis American depositary receipts were trading around $161.05 in late-morning New York trading, up 5.9% from the previous close of $152.06, after reaching an intraday high of $163.57. The move places the shares closer to their 52-week high of $170.46.
The reaction indicates that investors see the dual Phase III success as more than incremental pipeline news. Novartis generated $14.41 billion in second-quarter sales, but several established products face maturity or loss-of-exclusivity pressures, making new growth assets increasingly important to sustaining the company’s longer-term trajectory. Second-quarter growth was led by products including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio.
Remibrutinib could add another growth pillar if it succeeds across multiple indications. Beyond relapsing multiple sclerosis and chronic spontaneous urticaria, Novartis is studying the drug in secondary progressive multiple sclerosis, hidradenitis suppurativa, food allergy and other immune-mediated diseases.
The September 1 results considerably reduce the clinical risk surrounding the relapsing multiple sclerosis program, but important uncertainty remains. The full efficacy numbers have not yet been released, disability progression results are not uniformly statistically definitive, competition from Roche and other established multiple sclerosis therapies is substantial, and regulatory agencies must still evaluate the complete safety and efficacy package.
The MSToronto2026 presentation will therefore be the next major test. Detailed annualized relapse rates, magnetic resonance imaging findings, disability analyses and adverse-event data will show whether remibrutinib merely passed two pivotal studies or produced the level of differentiation required to become a significant commercial entrant in the crowded multiple sclerosis market.
