Novartis to unveil remibrutinib Phase III data at MSToronto2026
- Novartis to present late-breaking Phase III REMODEL-1/-2 data for remibrutinib at MSToronto2026
- Total of 46 abstracts from the multiple sclerosis portfolio will be showcased at the conference
- New evidence for Kesimpta in pediatric MS and breastfeeding safety to be presented
- Investor call scheduled to discuss remibrutinib data and potential market impact
*this image is generated using AI for illustrative purposes only.
Novartis will present new data from its multiple sclerosis (MS) portfolio at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. The company plans to highlight late-breaking results from the Phase III REMODEL-1 and REMODEL-2 trials, which evaluate the efficacy and safety of remibrutinib in relapsing MS.
The presentation schedule includes 46 abstracts covering various aspects of MS treatment. A key focus is the oral BTK inhibitor remibrutinib, with a dedicated investor call scheduled to discuss the data and its potential impact on the MS landscape.
Key clinical trial presentations
The company will also present data for Kesimpta (ofatumumab), including results from the Phase III NEOS study in pediatric MS. This study addresses significant unmet needs in pediatric patients, where approved treatment options remain limited. Additional Kesimpta data will cover pregnancy outcomes, breastfeeding safety, and comparisons against first-line therapies in treatment-naive patients.
| Abstract Title | Presentation Details |
|---|---|
| Efficacy and Safety of Remibrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the Phase 3 REMODEL-1/-2 Trials | Oral Presentation O139 October 23, 11:25 am ET |
| Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Multiple Sclerosis: The Innovative Phase 3 NEOS Study | Oral Presentation O138 October 23, 11:15 am ET |
| Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Efficacy Results of The Phase 3b STHENOS Study | Poster Session 1 P0390 October 21, 4:30 pm ET |
| Evaluating Ofatumumab Excretion in Breastmilk of Women Living With Relapsing Multiple Sclerosis: Interim Results of the Phase 4 KATHAROS Study | ePoster EP2565 |
Strategic focus on neuroscience
Nazem Atassi, Global Head of Neuroscience and Gene Therapy Development at Novartis, stated that the data reflects the company's commitment to addressing unmet needs across different stages of life and disease. The portfolio expansion includes work in neuroimmunology, neurodegeneration, and neuromuscular diseases, building on existing leadership in MS and spinal muscular atrophy.
What the numbers show
The breadth of the presentation, featuring 46 abstracts and specific late-breaking slots for both remibrutinib and Kesimpta, indicates a dual-track strategy. Novartis is simultaneously advancing a novel mechanism of action via BTK inhibition while reinforcing the evidence base for its established anti-CD20 therapy across diverse patient populations, including pediatric and pregnant cohorts.
Historical Stock Returns for Novartis
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -2.19% | -4.53% | -13.27% | 0.0% | 0.0% | 0.0% |
How might the Phase III REMODEL-1 and REMODEL-2 results for remibrutinib influence the competitive landscape against established BTK inhibitors from other major pharmaceutical players?
What regulatory pathways are expected for remibrutinib following these late-breaking results, and how quickly could it reach key markets like the US and EU?
How will the pediatric MS data from the NEOS study impact Novartis's market share in a segment currently dominated by off-label use of adult therapies?
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