Novartis announced positive topline results from its Phase III REMODEL-1/-2 trials of remibrutinib for relapsing multiple sclerosis on September 1, 2026. The oral Bruton’s tyrosine kinase (BTK) inhibitor demonstrated superiority versus teriflunomide in reducing annualized relapse rate and inflammatory brain lesions.

The trials met their primary endpoint, significantly reducing the annualized relapse rate compared to the active comparator. Remibrutinib also showed superiority on all key secondary endpoints within each trial, including a reduction in MRI lesions. These results establish remibrutinib as a BTK inhibitor achieving significant reductions in annualized relapse rate across two Phase III studies in adults with relapsing multiple sclerosis.

Clinical Efficacy and Safety

Remibrutinib delivered clinically meaningful reductions in key secondary endpoints related to disability progression. A preplanned combined analysis of REMODEL-1/-2 showed a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression.

The safety profile was consistent with the broader development program, which comprises more than 4,500 clinical trial participants across multiple indications. Remibrutinib was well tolerated with no liver safety signal, including no cases meeting Hy’s Law criteria.

What the Numbers Show

The clinical data indicates that remibrutinib addresses both inflammatory activity and disability progression simultaneously. While the primary endpoint focused on relapse rates, the secondary data points to potential long-term benefits in slowing disease advancement, supported by the nominal significance in 6-month confirmed disability progression.

Next Steps

Novartis plans to present late-breaking data at MSToronto2026 and intends to host an investor call following the congress presentation. The company plans to seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.

Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, stated that an unmet need remains for oral therapies delivering robust relapse prevention while maintaining a favorable safety profile. He noted that the findings reinforce the company’s ambition to drive innovation in multiple sclerosis care.

Novartis will present data from 10 abstracts across its cardiovascular portfolio at the 2026 European Society of Cardiology (ESC) Congress, reinforcing its leadership in addressing cardiovascular risk. The presentations cover foundational medicines such as Leqvio and Entresto, alongside promising investigational therapies including abelacimab and pacibekitug.

Ruchira Glaser, M.D., Global Head of Cardiovascular, Renal and Metabolic Development at Novartis , stated that the data underscores the company's commitment to advancing cardiovascular science for patients who remain at risk despite current treatment. The portfolio reflects a focus on addressing persistent challenges in cardiovascular care through bold science and a diverse pipeline.

Key Abstracts Accepted by ESC

The accepted abstracts span multiple therapeutic areas within cardiovascular disease, featuring both approved medicines and investigational candidates.

Portfolio Highlights

Key highlights from the presentations include:

• Leqvio: Late-breaking Phase IV VICTORION-CHALLENGE data will evaluate inclisiran against bempedoic acid in achieving LDL-C goals.
• Abelacimab: New AZALEA-TIMI 71 analyses will further characterize the bleeding profile in patients with atrial fibrillation, including recurrent bleeding events.
• Lp(a)CCELERATE: In partnership with the European Atherosclerosis Society (EAS), this initiative will explore strategies to help advance guideline-recommended Lp(a) testing in clinical practice.