诺华将在MSToronto2026公布remibrutinib III期REMODEL-1/-2阳性数据
Novartis advances multiple sclerosis innovation with late-breaking remibrutinib and broad portfolio data at MSToronto2026
诺华将于MSToronto2026公布remibrutinib对比teriflunomide治疗复发型多发性硬化的III期REMODEL-1/-2阳性数据，并召开投资者电话会。另有两项Kesimpta（ofatumumab）III期NEOS儿科MS及IIIb期STHENOS数据发布。
REMODEL-1/-2 数据读出或影响 remibrutinib 在 RMS 的注册与竞争定位判断。
Oct 07, 2026
- Late-breaking data from positive Phase III REMODEL-1/-2 trials will show efficacy and safety profile of remibrutinib in RMS
- Novartis to hold virtual investor event highlighting REMODEL data and remibrutinib in MS
- Phase III NEOS late-breaker will expand evidence for Kesimpta® (ofatumumab) in pediatric MS, where current approved treatment options remain limited
- New Kesimpta data from STHENOS study in treatment-naive relapsing MS and from KATHAROS breastfeeding study will be presented
Basel, October 07, 2026 – Novartis will present new data from its multiple sclerosis (MS) portfolio with 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. Among these is a late-breaking abstract featuring the Phase III REMODEL-1/-2 results, underscoring the potential of remibrutinib and reinforcing the company’s long-standing commitment to advancing care for people living with MS.
A second late-breaking abstract will present new Kesimpta® (ofatumumab) data in pediatric MS, where significant treatment needs remain. Additional presentations will further expand the Kesimpta evidence base, including research on pregnancy outcomes and breastfeeding that aims to inform family planning decisions, as well as the use of Kesimpta versus disease-modifying therapies commonly used as first-line treatments in treatment-naïve patients.
“For decades, Novartis has helped shape the treatment landscape for people living with multiple sclerosis through scientific innovation,” said Nazem Atassi, Global Head, Neuroscience and Gene Therapy Development, Novartis. “At MSToronto2026, we are sharing Phase III results from REMODEL-1 and REMODEL-2 evaluating remibrutinib, an oral BTK inhibitor, alongside new evidence across our MS portfolio. Together, these data reflect our continued commitment to addressing unmet needs across different stages of life and disease.”
Investor call on remibrutinib in MS
Following the presentation of the REMODEL data at MSToronto2026, Novartis will host a conference call for investors to provide updates on the data and the potential for remibrutinib in MS.
Key abstracts include
| Abstract Title | Presentation Details |
| Remibrutinib | |
| Efficacy and Safety of Remibrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the Phase 3 REMODEL-1/-2 Trials | Presentation ID O139 Oral Presentation October 23, 11:25 – 11:35 a.m. ET |
| Kesimpta (ofatumumab) | |
| Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Multiple Sclerosis: The Innovative Phase 3 NEOS Study | Presentation ID O138 Oral Presentation October 23, 11:15 – 11:25 a.m. 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 | Presentation ID P0390 Poster Session 1 October 21, 4:30 – 6:30 p.m. ET |
| Ofatumumab Versus Physicians’ Choice of Disease-Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Safety and Tolerability Results of The Phase 3b STHENOS Study | Presentation ID EP2632 ePoster |
| Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Healthcare Resource Utilization Results of the Phase 3b STHENOS Study | Presentation ID EP2625 ePoster |
| Evaluating Ofatumumab Excretion in Breastmilk of Women Living With Relapsing Multiple Sclerosis: Interim Results of the Phase 4 KATHAROS Study | Presentation ID EP2565 ePoster |
| Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study | Presentation ID P1139 Poster Session 2 October 22, 4:30 – 6:30 p.m. ET |
补充资料（3 节）药物、疾病与研究背景 · 法律与声明
药物、疾病与研究背景
About Novartis Neuroscience
Neurological diseases are deeply personal, affecting people of any age, from newborns to seniors, often striking in the prime of life. In multiple sclerosis (MS), Novartis has helped shape the treatment landscape for decades through scientific innovation and leadership in advancing care for people living with MS. We remain focused on addressing unmet needs and pursuing new approaches that may improve outcomes for people across the MS journey. Building on this foundation, we're doubling down on our commitment to neurology, expanding our legacy of innovation in MS and spinal muscular atrophy (SMA) to work in neuroimmunology, neurodegeneration, and neuromuscular diseases. Our goal is to protect people’s health across their lifespan, developing more treatment options that lead to better outcomes.
About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.
Reimagine medicine with us: Visit us at www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
# # #
法律与声明
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key products, commercial priorities and strategy; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
来源：Novartis｜诺华 · novartis.com