诺华 remibrutinib 在复发型多发性硬化三期试验中达到主要终点并计划全球申报

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6-K
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f6k_090126.htm
FORM 6-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K dated September 1, 2026
(Commission File No. 1-15024)
____________________
Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
____________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F:
Form 20-F: ☒
Form 40-F: ☐
Novartis
International AG
CH-4002
Basel
Switzerland
www.novartis.com
x.com/novartisnews
PRESS RELEASE
Novartis remibrutinib, a high-efficacy oral
BTK inhibitor, significantly reduces relapse rates and shows favorable safety profile in Phase III RMS trials
Ad hoc announcement pursuant to Art. 53 LR
·
REMODEL-1/-2 trials met their primary endpoint, significantly reducing annualized relapse rate (ARR) vs teriflunomide in people
living with relapsing multiple sclerosis (RMS)
1
·
Trials showed superiority of remibrutinib vs. teriflunomide on all key secondary endpoints within each trial, including reduction
of MRI lesions
1
·
A clinically meaningful delay in disability progression was achieved, including a positive trend in 3mCDP and nominally significant
6mCDP in preplanned combined analysis of REMODEL-1/-2
1
·
Remibrutinib demonstrated a favorable safety profile with no liver safety signal, consistent with remibrutinib in chronic spontaneous
urticaria (CSU)
1
·
Novartis to present late-breaking data at MSToronto2026 and plans to submit to health authorities globally
Basel, September 1, 2026
– Novartis today announced positive topline results from
its Phase III REMODEL-1/-2 trials of remibrutinib in relapsing multiple sclerosis.
1
Remibrutinib, a highly selective and potent
oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrated superiority versus teriflunomide in reducing annualized relapse rate
(ARR) and inflammatory brain lesions with a favorable safety profile. The results of the REMODEL trials establish remibrutinib as a BTK
inhibitor that achieved significant reductions in annualized relapse rate across two Phase III trials in adults with relapsing multiple
sclerosis (RMS).
1
Remibrutinib demonstrated clinically meaningful reductions versus teriflunomide
in key secondary endpoints related to disability progression, with a positive trend in 3-month confirmed disability progression (3mCDP)
and nominal significance in 6-month confirmed disability progression (6mCDP) in a preplanned combined analysis of REMODEL-1/-2.
1
The safety profile in REMODEL-1/-2 was consistent with the broader development
program of remibrutinib comprising more than 4,500 clinical trial participants in multiple indications.
1-4
Remibrutinib was
well tolerated and continues to demonstrate no liver safety signal, including no cases meeting Hy’s Law criteria.
“Despite advances in treatment, an unmet need remains for oral therapies
that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile. The positive REMODEL
results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk
profile,” said Shreeram Aradhye, President, Development, and Chief Medical Officer, Novartis. “Building on our long-standing
commitment to advancing care in MS, these findings reinforce our continued ambition on driving innovation in this space and delivering
therapies that address the evolving needs of people living with MS.”
Novartis will present the REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026 and
intends to host an investor call following the congress presentation. Novartis plans to seek regulatory approval for remibrutinib in RMS
globally.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous
system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord.
5
MS, which affects
nearly 3 million people worldwide, can be characterized into three main types: non-active secondary progressive (SPMS), primary progressive
(PPMS), and relapsing MS (RMS).
6-7
RMS is the most common form and includes clinically isolated syndrome (CIS), relapsing-remitting
(RRMS), and active SPMS.
7
The various forms of MS are distinguished by how the disease presents and progresses, including whether
patients experience relapses, worsening disability over time, or a combination of both.
8
About Remibrutinib
Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase (BTK)
inhibitor that blocks the BTK pathway
,
reducing activation of B cells and innate immune cells to modulate immune regulatory networks
and related neuroinflammation.
9-12
Discovered at Novartis, remibrutinib is being investigated in neuroscience indications,
including the Phase III trials REMODEL in RMS, REMASTER in SPMS, as well as other immune-mediated conditions, such as hidradenitis suppurativa
and food allergy.
13-14
Remibrutinib 25 mg was approved as Rhapsido® by the FDA in September 2025 and the EMA in April 2026
for the treatment of adults with chronic spontaneous urticaria (CSU).
15,16
About the REMODEL Trials
REMODEL-1/-2 are identical multicenter, randomized, double-blind, active comparator-controlled
Phase III studies evaluating the efficacy and safety of remibrutinib compared to teriflunomide for adult patients with relapsing multiple
sclerosis (RMS).
17,18
Approximately 2,000 patients globally with evidence of recent disease activity and an Expanded Disability
Status Scale (EDSS) of 0.0–5.5 were randomized 1:1 to receive remibrutinib 100 mg or teriflunomide. The studies consist of an initial
double-blind Core Part with a flexible duration of up to a maximum of 30 months, followed by an open-label extension for up to 5 years.
The primary endpoint is annualized relapse rate (ARR). Key secondary endpoints include 3- and 6-month confirmed disability progression,
the number of new/enlarging T2 lesions per year, the number of Gd+ T1 lesions per scan, serum neurofilament light chain (sNfL) concentration,
and the percentage of participants with no evidence of disease activity (NEDA-3).
17-19
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.
Product Information
For full prescribing information, including approved indications and important safety information about
marketed products, please visit
https://www.novartis.com/about/products
.
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,” “believe,” “committed,” “investigational,”
“launch,” “building,” “maintaining,” “continued,” “evolving,” or similar expressions,
or by express or implied discussions regarding: potential new products including remibrutinib; potential new indications for existing
products; potential product launch of
remibrutinib
or potential future revenues from
remibrutinib
;
results of ongoing clinical trials; or potential future, pending or announced transactions; or potential future sales or earnings from
remibrutinib
;. 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
remibrutinib
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
remibrutinib
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; the implementation of our
new IT projects and systems; 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.
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:
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References
1.
Data on file
2.
Metz M, Giménez-Arnau AM, Hide M, et al. Remibrutinib in chronic spontaneous urticaria.
N Engl J Med
. 2025;392(10):984-994.
doi:10.1056/NEJMoa2408792
3.
Giménez-Arnau AM, Szalewski R, Hide M, et al. Remibrutinib in chronic spontaneous urticaria: 52-week results from two phase
3 studies.
J Allergy Clin Immunol
. 2026;157(1):143-154. doi:10.1016/j.jaci.2025.09.028
4.
Novartis. Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible
urticaria (CIndU). Novartis US. Published February 18, 2026. Available from:
https://www.novartis.com/us-en/news/media-releases/novartis-remibrutinib-first-therapy-achieve-phase-iii-primary-endpoint-chronic-inducible-urticaria-cindu
Last accessed: August 6, 2026
5.
Ferreira HB, Neves B, Guerra IM, Moreira A, Melo T, Paiva A, Domingues MR. An overview of lipidomic analysis in different human matrices
of multiple sclerosis. Mult Scler Relat Disord. 2020;44:102189. doi:10.1016/j.msard.2020.102189
6.
Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical
course
. Lancet Reg. Health Eur.
2024;44:100977.
7.
National Multiple Sclerosis Society. Types of MS. Available from:
https://www.nationalmssociety.org/What-is-MS/Types-of-MS
Last
accessed: July 15, 2026
8.
Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions.
Neurology
.
2014;83(3):278-286. doi:10.1212/WNL.0000000000000560
9.
Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (Remibrutinib), a Potent and Highly Selective Covalent Inhibitor of Bruton's
Tyrosine Kinase.
J Med Chem
. 2020;63(10):5102-5118. doi:10.1021/acs.jmedchem.9b01916
10.
Kaul M, End P, Cabanski M, et al. Remibrutinib (LOU064): A selective potent oral BTK inhibitor with promising clinical safety and
pharmacodynamics in a randomized phase I trial.
Clin Transl Sci
. 2021;14(5):1756-1768. doi:10.1111/cts.13005
11.
Jain RW, Rayatpour A, Hagen K, et al. Investigations of remibrutinib in models pertinent to multiple sclerosis.
Neurotherapeutics
.
2026;23(3):e00923. doi:10.1016/j.neurot.2026.e00923
12.
Nuesslein-Hildesheim B, Ferrero E, Schmid C, et al. Remibrutinib (LOU064) inhibits neuroinflammation driven by B cells and myeloid
cells in preclinical models of multiple sclerosis.
J Neuroinflammation
. 2023;20(1):194. Published 2023 Aug 26. doi:10.1186/s12974-023-02877-9
13.
ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients
with moderate to severe hidradenitis suppurativa. Available from:
https://clinicaltrials.gov/ct2/show/NCT03827798
.
Last accessed: July 2026
14.
ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult
participants with an allergy to peanuts. Available from:
https://clinicaltrials.gov/study/NCT05432388
Last
accessed: July 2026
15.
Novartis. Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted
BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Available from:
https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu
Last accessed: August 6, 2026
16.
Novartis. Novartis Rhapsido® receives European Commission approval as first oral targeted treatment
for chronic spontaneous urticaria. News release. Novartis. April 27, 2026. Available from:
https://www.novartis.com/news/media-releases/novartis-rhapsido-receives-european-commission-approval-first-oral-targeted-treatment-chronic-spontaneous-urticaria
Last accessed: August 6, 2026
17.
ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in
participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from:
https://clinicaltrials.gov/study/NCT05147220
Last accessed: July 2026
18.
ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in
participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from:
https://clinicaltrials.gov/study/NCT05156281
Last accessed: July 2026
19.
Wiendl H, Airas L, Chitnis T, et al. Phase 3 REMODEL I/II Trials: Efficacy, Safety, and Tolerability of Remibrutinib in Patients with
Relapsing Multiple Sclerosis. Mult Scler Relat Disord. 2023;80:105315. doi:10.1016/j.msard.2023.105315
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Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Novartis AG
Date: September 1, 2026
By:
/s/ PAUL
PENEPENT
Name:
Paul Penepent
Title:
Head of Financial Reporting and Accounting