![\"\"\/](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/06\/hdrbg.jpg\")
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UNITED STATES<\/p>\n
SECURITIES AND EXCHANGE COMMISSION<\/p>\n
Washington, D.C. 20549<\/p>\n
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FORM 6-K<\/p>\n
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REPORT OF FOREIGN PRIVATE ISSUER<\/p>\n
PURSUANT TO RULE 13a-16 or 15d-16 OF<\/p>\n
THE SECURITIES EXCHANGE ACT OF 1934<\/p>\n
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Report on Form 6-K dated June 11, 2026<\/p>\n
(Commission File No. 1-15024)<\/p>\n
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____________________<\/p>\n
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Novartis AG<\/p>\n
(Name of Registrant)<\/p>\n
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Lichtstrasse 35<\/p>\n
4056 Basel<\/p>\n
Switzerland<\/p>\n
(Address of Principal Executive Offices)<\/p>\n
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____________________<\/p>\n
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Indicate by check mark whether the registrant files or will file annual reports under
\ncover of Form 20-F or Form 40-F:<\/p>\n
Form 20-F:\u00a0\u2612
\n \u00a0
\n Form 40-F:\u00a0\u2610<\/p>\n
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![\"\"](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/06\/logo.jpg\"){kind=logo}
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Novartis
\n International AG<\/p>\n
CH-4002
\nBasel<\/p>\n
Switzerland<\/p>\n
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https:\/\/www.novartis.com<\/p>\n
https:\/\/x.com\/novartisnews<\/p>\n
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PRESS RELEASE<\/p>\n
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Novartis delpacibart braxlosiran
\n(del-brax) Phase I\/II study in facioscapulohumeral muscular dystrophy
\n(FSHD) meets primary biomarker endpoint<\/p>\n
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Ad hoc announcement pursuant to Art. 53 LR<\/p>\n
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\u00b7FORTITUDE study met primary and key secondary endpoints of reduction in KHDC1L
\nand creatine kinase levels, with safety profile consistent with previous results <\/p>\n
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\u00b7Del-brax indicates potential to become the first disease-modifying treatment for
\nFSHD, a progressive and irreversible neuromuscular disease affecting approximately 45-87k people in the US and EU <\/p>\n
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\u00b7Novartis plans to engage global regulatory authorities on Phase I\/II data; Phase
\nIII study currently enrolling<\/p>\n
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Basel, June 11, 2026 \u2013 Novartis announced
\ntoday that the biomarker cohort of the FORTITUDE Phase I\/II study of del-brax met its primary and key secondary endpoints, with reductions
\nin KHDC1L (cDUX) and creatine kinase biomarker levels indicating both strong target engagement and reduction in muscle damage in patients
\nwith facioscapulohumeral muscular dystrophy (FSHD). Del-brax
\nis an investigational antibody oligonucleotide conjugate (AOC) \u2013 a new class of RNA therapeutics \u2013 showing potential to become
\nthe first disease-modifying treatment for FSHD, a rare, irreversible neuromuscular disease marked by relentless loss of muscle function
\nand progressive disability.<\/p>\n
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\u201cThe FORTITUDE biomarker cohort data importantly replicate the target engagement and downstream
\nmuscle protection seen with del-brax in earlier dose-escalation cohorts. These results validate the dosing regimen implemented in our
\nPhase III trial and lend further evidence of the potential for del-brax to have a significant impact for people with FSHD,\u201d said
\nNazem Atassi, Global Head, Neuroscience and Gene Therapy Development, Novartis. \u201cWe are now evaluating the totality of the biomarker
\nand clinical data and look forward to discussions with global regulatory agencies as we work with urgency to advance the development of
\ndel-brax for patients in need.\u201d<\/p>\n
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Del-brax is designed to address the root cause of FSHD, the aberrant expression of DUX4. Combining
\nthe tissue specificity of monoclonal antibodies with the precision of oligonucleotides, the AOC platform enables targeted delivery of
\nsiRNA to suppress DUX4 expression in previously hard-to-reach muscle cells of FSHD patients. Del-brax is the only investigational agent
\nshowing disease-modifying potential for FSHD in clinical studies. This investigational therapy has received FDA Orphan Drug and Fast Track
\ndesignations, and EMA Orphan Drug designation, and is currently in Phase III development.<\/p>\n
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Del-brax is one of three potential first-in-class,
\nlate-stage, disease-modifying AOC therapies added to the Novartis neuroscience pipeline through the acquisition of
\nAvidity Biosciences completed in February 2026. Beyond del-brax for FSHD, the Avidity acquisition included delpacibart-etedesiran (del-desiran)
\nin Phase III development for myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying
\ntherapies; and delpacibart-zotadirsen (del-zota) in Phase II development for Duchenne muscular dystrophy (DMD), a severe, early-onset
\ndisease marked by progressive muscle damage and reduced life expectancy. Together, these programs build on Novartis\u2019 expertise in
\nspinal muscular atrophy, creating an industry-leading neuromuscular pipeline.<\/p>\n
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About the del-brax FORTITUDE clinical development program<\/p>\n
The FORTITUDE
\nPhase I\/II study (NCT05747924) is
\na randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics
\nand exploratory efficacy of del-brax in 90 patients with FSHD.<\/p>\n
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The Phase I\/II trial has three dose cohorts. The
\nfirst two dose escalation cohorts A & B evaluated del-brax 2 mg\/kg or 4 mg\/kg versus placebo and were designed to assess safety as
\nwell as inform the dose and dose regimen of\u00a0del-brax. Topline results from these two initial cohorts were presented at
\nthe 32nd FSHD International Research Congress in June 2025. Based on these results, the del-brax 2 mg\/kg dose every 6 weeks
\nwas selected for Cohort C and the Phase III study.<\/p>\n
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Cohort C, a biomarker cohort, assessed the impact of\u00a0del-brax\u00a02 mg\/kg every 6 weeks versus
\nplacebo for 12 months in 51 FSHD patients aged 16-70. The primary endpoint of the study cohort was change in plasma concentration of KHDC1L,
\na DUX4-regulated circulating biomarker. The key secondary endpoint was change from baseline in the levels of creatine kinase, a marker
\nof muscle damage.<\/p>\n
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FORTITUDE-3 (NCT07038200),
\na randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of del-brax, is currently enrolling
\n200 patients with FSHD aged 16-70 years. The primary endpoint is quantitative muscle testing (QMT) in the US and the 10-meter walk\/run
\ntest (10MWRT) in Europe. Secondary endpoints include additional clinical functional measures, patient-reported outcomes on signs and symptoms
\nof FSHD, and biomarkers.<\/p>\n
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About FSHD <\/p>\n
Facioscapulohumeral
\nmuscular dystrophy (FSHD) is one of the most common forms of muscular dystrophy and is caused by aberrant expression of the DUX4 gene.
\nThe rare neuromuscular disease is estimated to affect between 45,000 to 87,000 people in the US and EU. People with FSHD typically begin
\nto experience symptoms in their teenage or early adult years, characterized by progressive muscle weakness, pain, fatigue and disability.
\nThe disease leads to a steady loss of independence, with 20% of patients becoming wheelchair dependent. There are no currently approved
\ntherapies for FSHD.<\/p>\n
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Novartis in neuroscience<\/p>\n
Neurological diseases are deeply personal, affecting people of any age, from newborns to seniors,
\noften striking in the prime of life. At Novartis, we are doubling down on our commitment to neurology, expanding our legacy of innovation
\nin spinal muscular atrophy (SMA) and multiple sclerosis (MS) to work in neuroimmunology, neurodegeneration, and neuromuscular diseases.\u00a0Our
\ngoal is to protect people\u2019s health across their lifespan, developing more treatment options that lead to better outcomes.<\/p>\n
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Disclaimer<\/p>\n
This press release contains forward-looking statements within the meaning of the United States Private
\nSecurities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as \u201cpotential,\u201d
\n\u201ccan,\u201d \u201cwill,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cexpect,\u201d
\n\u201canticipate,\u201d \u201clook forward,\u201d \u201cinvestigational,\u201d \u201cpipeline,\u201d \u201cgoal,\u201d or similar
\nexpressions, or by express or implied discussions regarding: potential new products, including del-brax, del-desiran and del-zota; potential
\nproduct launch of del-brax or potential future revenues from del-brax; results of ongoing clinical trials; or potential future, pending
\nor announced transactions; or potential future sales or earnings from del-brax;. You should not place undue reliance on these statements.
\nSuch forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject
\nto significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying
\nassumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no
\nguarantee that del-brax will be submitted or approved for sale or for any additional indications or labeling in any market, or at any
\nparticular time. Nor can there be any guarantee that del-brax will be commercially successful in the future. In particular, our expectations
\ncould be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government,
\npayer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key
\nproducts, commercial priorities and strategy; research and development of new products, including clinical trial results and additional
\nanalysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate
\nextent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic
\nbenefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of
\nnew technologies, including artificial intelligence, and new business models; potential significant breaches of information security or
\ndisruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government
\nregulation related to del-brax; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political
\ndevelopments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future
\nglobal exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG\u2019s most recently filed
\nForm 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the
\ninformation in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a
\nresult of new information, future events or otherwise.<\/p>\n
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About Novartis <\/p>\n
Novartis is an innovative medicines company. Every
\nday, we work to reimagine medicine to improve and extend people\u2019s lives so that patients, healthcare professionals and societies
\nare empowered in the face of serious disease. Our medicines reach more than 300 million people
\nworldwide.<\/p>\n
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Reimagine medicine with us: Visit
\nus at www.novartis.com and connect with us on LinkedIn,
\nFacebook, X\/Twitter
\nand Instagram.<\/p>\n
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# # #<\/p>\n
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Novartis Media Relations<\/p>\n
E-mail: media.relations@novartis.com<\/p>\n
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Novartis Investor Relations<\/p>\n
Central investor relations line: +41 61 324
\n 7944<\/p>\n
E-mail: investor.relations@novartis.com<\/p>\n
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SIGNATURES<\/p>\n
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Pursuant to
\nthe requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
\nby the undersigned, thereunto duly authorized.<\/p>\n
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\u00a0
\n Novartis AG
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Date: June 11, 2026
\n By:
\n \/s\/ PAUL
\n PENEPENT
\n \u00a0<\/p>\n
\u00a0
\n Name:\u00a0
\n Paul Penepent
\n \u00a0<\/p>\n
\u00a0
\n Title:
\n Head of Financial Reporting and Accounting<\/p>\n
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