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 ~~August~~September 1130, 2025

(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

https://www.novartis.com

http://x.com/NovartisNews

PRESS RELEASE

Novartis ~~announces~~receives ~~both~~FDA ~~ianalumab~~approval for ~~Phase~~Rhapsido® ~~III~~(remibrutinib), ~~clinical~~the ~~trials met~~only ~~primary~~oral, ~~endpoint~~targeted inBTKi ~~patients~~treatment ~~with~~for ~~Sjögren’s~~chronic ~~disease~~ spontaneous urticaria (CSU)

Ad hoc announcement pursuant to Art. 53 LR

●· ~~NEPTUNUS-1~~Rhapsido ~~and~~helps ~~NEPTUNUS-2~~to ~~are~~inhibit ~~the~~release ~~first~~of ~~ever~~histamine ~~global~~and ~~phase~~proinflammatory ~~III~~mediators ~~trials~~by totargeting ~~demonstrate~~BTK, ~~statistically~~offering ~~significant~~unique ~~reduction~~approach into ~~disease~~CSU ~~activity for Sjögren’s disease1~~treatment1

●· ~~Ianalumab~~Well-controlled ~~has~~disease ~~the~~observed ~~potential~~as tofast ~~become~~as ~~the~~two ~~first~~weeks, ~~and~~with ~~only~~demonstrated ~~targeted~~safety ~~treatment~~profile ~~approved~~that ~~for~~requires ~~patients~~no ~~with~~lab ~~Sjögren’s disease~~monitoring1

●· ~~Ianalumab~~1.7 ~~was~~million ~~well~~people ~~tolerated~~in ~~and~~US ~~demonstrated~~live awith ~~favorable~~CSU; ~~safety~~more ~~profile~~than inhalf ~~Sjögren's~~remain ~~disease1~~symptomatic despite increasing doses of antihistamines2,23

●· ~~Novartis~~Remibrutinib ~~plans~~also toin ~~present~~clinical ~~its~~development ~~data~~for atchronic aninducible ~~upcoming~~urticaria, ~~medical~~food ~~congress~~allergy, and ~~submit~~hidradenitis tosuppurativa, ~~health~~expanding ~~authorities~~Novartis ~~globally~~Immunology portfolio

Basel, ~~August~~September 1130, 2025 – Novartis ~~today~~ announced ~~positive~~today ~~top-line~~that Rhapsido® ~~results~~(remibrutinib) ~~from~~received ~~its~~US ~~Phase~~Food ~~III~~and ~~trials~~Drug ~~evaluating~~Administration ~~ianalumab~~ (~~VAY736~~FDA) inapproval ~~adults~~as ~~with~~an ~~active~~oral ~~Sjögren's~~treatment for ~~disease.~~adult ~~Both~~patients ~~trials~~with ~~met~~chronic ~~the~~spontaneous ~~primary~~urticaria ~~endpoint~~(CSU) ofwho ~~demonstrating~~remain ~~statistically~~symptomatic ~~significant improvements~~despite inH1 ~~disease~~antihistamine ~~activity1~~treatment. ~~These~~Rhapsido ~~results~~is ~~support~~a ~~the~~pill taken ~~potential~~twice ~~for~~daily ~~ianalumab,~~and adoes ~~drug~~not ~~with~~require ainjections ~~dual~~or ~~mechanism of~~lab ~~action,~~monitoring. ~~B-cell~~It ~~depletion~~is ~~and~~the ~~BAFF~~first FDA-Rapproved ~~inhibition,~~Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido helps to ~~become~~inhibit the ~~first~~release ~~targeted~~of ~~treatment~~histamine ~~for~~and ~~patients~~other ~~with~~proinflammatory ~~Sjögren’s~~mediators ~~disease~~by targeting BTK, offering a ~~chronic,~~unique approach ~~disabling~~to ~~autoimmune~~CSU ~~disease3,4,5~~treatment. 1

~~"Sjögren’s~~“CSU ~~disease~~ is a serious, ~~progressive~~disease that can cause debilitating symptoms and unpredictable flares. It’s difficult to diagnose and manage,” ~~systemic~~said ~~autoimmune~~Mark ~~disease~~Lebwohl, ~~often~~MD, ~~unrecognized~~Dean orfor ~~misdiagnosed~~Clinical ~~with~~Therapeutics aat ~~significant~~the ~~detrimental~~Icahn ~~impact~~School toof ~~quality~~Medicine ofat ~~life,~~Mount ~~with~~Sinai ~~very~~and ~~limited~~member ~~treatment~~of ~~options~~the ~~and~~steering ancommittee ~~established~~for ~~unmet~~the ~~need.~~remibrutinib ~~Both~~REMIX Phase III ~~trials~~clinical ~~demonstrate~~trial program. ~~that~~“Remibrutinib ~~ianalumab~~represents ~~improves~~a ~~disease~~new ~~activity~~way inof ~~patients~~treating ~~with Sjogren’s disease~~CSU.” ~~said~~By ~~Shreeram~~blocking ~~Aradhye,~~the ~~M.D.,~~activity ~~President~~ of ~~Development and~~BTK, ~~Chief~~remibrutinib ~~Medical~~stops ~~Officer~~a atkey ~~Novartis.~~pathway ~~“These~~of ~~Phase~~the ~~III~~immune response ~~studies~~in ~~mark~~CSU. aThis ~~significant~~is ~~milestone.~~an Weexciting ~~look~~new ~~forward~~option tothat ~~engaging~~has ~~with~~the ~~health authorities~~potential to ~~discuss~~help ~~these~~a ~~findings~~broad inrange ~~the~~of ~~near~~patients ~~future~~get fast relief.”

~~The~~CSU ~~NEPTUNUS~~is ~~pivotal~~a ~~trials~~mast ~~achieved~~cell-driven ~~the~~condition ~~primary~~thought ~~endpoint~~to ofbe ~~improving~~caused ~~disease~~by ~~activity~~immune ~~measured~~dysregulation. In bypeople awith ~~reduction~~CSU, inthe ~~EULAR~~immune ~~Sjögren’s syndrome~~system ~~disease~~can ~~activity~~become ~~index~~activated through allergic (~~ESSDAI~~IgE), aor ~~multi-dimensional~~autoimmune ~~disease~~(IgG) ~~activity~~pathways.4 This ~~measurement~~causes ~~compared~~certain immune cells—mast cells and basophils—to ~~placebo1~~activate the BTK protein. ~~Ianalumab~~While not fully understood, it is believed ~~was~~that ~~well~~once ~~tolerated~~activated, BTK leads to the release of histamine and ~~demonstrated~~other aproinflammatory ~~favorable~~mediators ~~safety~~that ~~profile~~may incause ~~Sjögren's~~the ~~disease1~~red,2 swollen, and itchy hives commonly seen in CSU.5,6

~~Novartis~~CSU ~~plans~~symptoms toare ~~present~~unpredictable, ~~the~~recurring ~~NEPTUNUS-1~~for ~~and~~six ~~NEPTUNUS-2~~weeks ~~data~~or atmore without an ~~upcoming~~identified ~~medical~~cause.7 ~~meeting~~Diagnosis ~~and~~can ~~submit~~take ~~ianalumab,~~up ~~which~~to ~~was~~24 ~~granted~~months.8 ~~Fast~~Many ~~Track~~CSU ~~Designation~~patients bysay ~~the~~their USsymptoms ~~Food~~negatively impact their sleep, work, and ~~Drug~~mental ~~Administration~~health.9,10,11 Antihistamines ~~(FDA)~~are the first-line treatment, but over half of patients still have symptoms, even at higher doses.2 Injectable treatments exist for those who don't respond to ~~health~~antihistamines, ~~authorities~~yet ~~globally6~~fewer than 20% of eligible patients receive them. 12

~~About~~“The ~~ianalumab Ianalumab~~approval ~~(VAY736)~~of remibrutinib is aan ~~novel~~important ~~fully~~development ~~human~~in ~~monoclonal~~CSU care. ~~antibody~~It ~~being~~quickly ~~investigated~~reduces ~~for~~symptoms, ~~its~~offering ~~potential~~patients tocontrol ~~treat~~of ~~various~~the Bhives ~~cell-driven autoimmune~~and ~~diseases,~~itching ~~including~~that ~~Sjögren’s~~they ~~disease,~~experience ~~immune~~on ~~thrombocytopenia~~a ~~(ITP),~~daily ~~systemic lupus erythematosus (SLE)~~basis,” ~~lupus~~said ~~nephritis~~Giselle ~~(LN)~~Mosnaim, ~~warm~~MD, ~~autoimmune~~MS, ~~hemolytic~~an ~~anemia~~Allergist ~~(wAIHA)~~ and ~~diffuse~~Immunologist ~~cutaneous~~from ~~systemic~~Endeavor ~~sclerosis (dcSSc)3~~Health,~~7-13.~~ ~~Its~~Clinical ~~mechanism of~~Associate ~~action~~Professor ~~targets~~at Bthe ~~cells~~University inof ~~two ways, namely combining B cell depletion via antibody-dependent cellular toxicity (ADCC) and interruption~~Chicago ofPritzker ~~BAFF-~~School ~~R mediated signals~~ of BMedicine ~~cell~~and ~~function~~REMIX ~~and~~trial ~~survival3~~investigator. In“This ~~clinical~~is ~~trials,~~significant ~~ianalumab~~because ~~showed~~it ~~promising~~expands ~~efficacy~~beyond ~~and a~~existing ~~favorable~~injectable ~~safety profile in Sjögren’s disease, systemic lupus erythematosus,~~ treatments and ~~immune~~gives ~~thrombocytopenia2,14,15. Ianalumab~~patients ~~originates from~~ an ~~early~~oral ~~collaboration~~option ~~with~~that ~~MorphoSys~~can ~~AG,~~easily abe ~~company~~incorporated ~~which~~into ~~Novartis~~their ~~later~~daily ~~acquired in 202416~~lives. ”

~~About~~“Many ~~NEPTUNUS-1~~CSU patients feel misunderstood and ~~NEPTUNUS-2~~ settle for treatments ~~The~~that ~~phase~~don’t ~~III~~fully ~~clinical~~meet ~~trials~~their needs,” ~~NEPTUNUS-1~~said ~~and~~Lynda ~~NEPTUNUS-2~~Mitchell, ~~are~~CEO ~~global, multicenter,~~of ~~pivotal~~Allergy ~~studies~~& ~~evaluating~~Asthma ~~the~~Network. ~~efficacy~~“We ~~and~~support ~~safety~~new oftreatment options ~~ianalumab~~that inempower patients ~~with~~to ~~Sjögren’s~~choose ~~disease7,8. These~~what ~~trials~~works ~~were~~best ~~designed~~for tothem. ~~provide~~This ~~comprehensive~~convenient ~~data~~new onoral ~~ianalumab's~~therapy ~~potential~~offers as a ~~targeted~~promising ~~treatment~~new ~~for~~way ~~Sjögren’s~~to ~~disease,~~manage inCSU ~~patients~~and potentially improve daily life for those living with ~~active~~this ~~extraglandular~~challenging ~~disease~~condition.~~3,7,8.~~ ”

~~NEPTUNUS-1~~Clinical isdata asupporting randomized, double-blind, 2-arm multicenter phase III trial (N=275) to evaluate the clinical efficacy, safety, and tolerability of ianalumab 300 mg subcutaneous (s.c.) monthly compared with placebo for 52 weeks7. NEPTUNUS-2 is a randomized, double-blind, 3-arm multicenter phase III trial (N=504) to evaluate the clinical efficacy, safety, and tolerability of ianalumab 300 mg s.c. monthly or every 3 months compared with placebo for up to 52 weeks8. approval

The ~~primary~~FDA ~~endpoint~~approval ~~was~~of ~~measured~~Rhapsido byin ~~improvements~~CSU is based on results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials in ~~systemic~~patients ~~disease~~who ~~activity~~remained ~~using~~symptomatic ~~ESSDAI~~on second-generation H1 antihistamines. Rhapsido demonstrated superiority in change from baseline versus placebo in itch (~~EULAR~~ISS7), ~~Sjögren’s~~hives ~~syndrome~~(HSS7), ~~disease~~and weekly urticaria activity ~~index~~(UAS7)~~7,8~~ at Week 12.13 ~~Patients~~Significantly ~~currently~~more ~~enrolled~~patients intreated ~~NEPTUNUS-1~~with ~~and~~Rhapsido ~~NEPTUNUS~~versus placebo achieved well-2controlled ~~have~~disease ~~been~~(UAS7≤6) ~~given~~as ~~the~~early ~~opportunity~~as toWeek ~~continue~~2 ~~follow~~and at Week 12, and about one-upthird of patients achieved complete inabsence ~~these~~of ~~studies~~itch orand ~~enter~~hives at Week 12.13 Rhapsido has a ~~long-term~~demonstrated ~~extension~~safety ~~trial17~~profile that requires no lab monitoring. 13 The most common adverse events (incidence ≥3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain.13

~~About~~Novartis ~~Sjögren’s~~has ~~disease~~completed ~~(previously~~regulatory ~~called~~submissions ~~Sjögren’s~~for ~~syndrome) Sjögren’s~~Rhapsido ~~disease~~for ~~is a systemic, chronic autoimmune disorder that causes inflammation and tissue damage, impacting~~ the ~~entire body4. It primarily~~treatment ~~affects exocrine glands, leading to excessive dryness, with over 90 percent~~ of ~~patients~~CSU ~~experiencing~~across ~~dry~~many ~~eyes and dry mouth4~~countries,~~18. The~~ ~~disease~~including isin ~~heterogenous,~~the ~~patients~~European ~~experience dryness~~Union, ~~fatigue and widespread pain and 30-40 percent of patients will also show extraglandular organ involvement5~~Japan,~~19.~~ ~~Extraglandular manifestation can be very diverse~~ and ~~can affect skin~~China, ~~musculoskeletal~~with ~~system,~~priority ~~kidneys, lungs~~review ~~and~~granted ~~other organs19. The risk of lymphoma is increased~~ in ~~patients with Sjögren’s5~~China.

~~Sjögren’s~~Transforming iscare ~~one of the most prevalent rheumatic autoimmune diseases, affecting approximately 0.25 percent of the population with an estimated 50 percent undiagnosed 20-21. Sjögren’s is nine times more common~~ in women than men4. B cell dysfunction plays a significant role in the disease by causing an autoimmune response that leads to inflammation and tissue damage3,4. There are no systemic treatments approved, with only limited symptomatic treatments available to provide temporary and partial symptomatic relief, highlighting the need for effective targeted therapies3. Immunology

~~Disclaimer~~ “This ~~press~~approval ~~release contains forward-looking statements within the meaning~~ of ~~the~~Rhapsido ~~United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such~~ as ~~“potential,”~~the ~~“can,” “will,”~~first ~~“plan,”~~and ~~“may,”~~only ~~“could,”~~BTK ~~“would,”~~inhibitor ~~“investigational,” “pipeline,”~~in ~~“upcoming,”~~CSU ~~“intends,”~~is oran ~~similar~~important ~~terms,~~milestone orin byour ~~express~~journey orto ~~implied~~reshape ~~discussions~~care ~~regarding potential marketing approvals, new indications or labeling~~ for ~~ianalumab,~~overlooked ~~or regarding potential future revenues from ianalumab. You should not place undue reliance on these statements. Such forward~~immune-~~looking~~related ~~statements~~conditions ~~are based on our current beliefs~~ and ~~expectations~~offer ~~regarding~~more ~~future~~patients ~~events,~~the ~~and are~~potential ~~subject~~ to ~~significant~~find ~~known~~fast ~~and~~relief,” ~~unknown~~said ~~risks~~Victor ~~and uncertainties. Should one or more of these risks or uncertainties materialize~~Bultó, ~~or should underlying assumptions prove incorrect~~President, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that ianalumab will be submitted or approved for sale or for any additional indications or labeling in any marketUS, ~~or at any particular time~~Novartis. ~~Nor~~“Building ~~can~~on ~~there~~our belegacy ~~any guarantee that ianalumab will be commercially successful~~ in ~~the~~advancing ~~future. In particular, our expectations regarding ianalumab could be affected by, among other things,~~ the ~~uncertainties inherent in research and development,~~treatment ~~including clinical trial results and additional analysis~~ of ~~existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment~~allergic, ~~including government~~dermatologic, ~~payor~~ and ~~general~~rheumatologic public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, ~~including~~we ~~the effects~~are ofdeeply ~~and~~committed ~~efforts~~ to ~~mitigate~~further ~~pandemic~~investing ~~diseases;~~in ~~safety~~innovative, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20patient-F ~~on file with the US Securities and Exchange Commission. Novartis is providing the information in~~focused ~~this~~therapies ~~press~~across ~~release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise~~immunology.”

~~About~~Discovered ~~Novartis~~and ~~Novartis~~developed isby anNovartis ~~innovative~~to ~~medicines~~target ~~company.~~the ~~Every~~BTK ~~day,~~pathway weas ~~work~~a todriver of ~~reimagine~~inflammation, ~~medicine~~remibrutinib tois ~~improve~~being ~~and~~investigated ~~extend people’s~~in ~~lives~~ongoing soclinical ~~that~~trials ~~patients,~~across ~~healthcare~~a ~~professionals~~variety ~~and~~of ~~societies~~immune-related ~~are~~conditions, ~~empowered~~including chronic ininducible ~~the~~urticaria ~~face~~(CIndU), ofhidradenitis ~~serious~~suppurativa ~~disease.~~(HS), ~~Our~~and ~~medicines reach~~food ~~nearly 300 million people worldwide~~allergy.

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,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products.You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with 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 contained in this press release 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 nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

1. ~~Novartis~~Rhapsido® ~~data~~(remibrutinib) onPrescribing ~~files~~Information. Novartis Pharmaceuticals Corp.

2. ~~Bowman~~Maurer SM, etWeller alK, ~~Safety~~Bindslev-Jensen ~~and~~C, ~~efficacy~~et ofal. ~~subcutaneous~~Unmet ~~ianalumab~~clinical ~~(VAY736)~~needs in ~~patients~~chronic ~~with~~spontaneous ~~primary~~urticaria. ~~Sjogren’s~~A ~~syndrome:~~GA²LEN atask ~~randomized,~~force ~~double-blind,~~report. ~~placebo-controlled,~~Allergy. ~~phase 2b dose~~2011;66:317-~~finding~~330. ~~trial, Lancet 2022; 399~~doi:~~161~~10.1111/j.1398-719995.2010.02496.x

3. ~~Dorner~~The TWorld etBank. alPopulation, ~~Safety~~total. ~~and~~Accessed ~~Efficacy~~June ~~of ianalumab in patients with Sjogren’s disease:52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study, Arhtritis and Rheumatology~~ 2025,. ~~77(5)~~https:~~560-570~~//data.worldbank.org/indicator/SP.POP.TOTL

4. ~~Negrini~~Kolkhir SP, Muñoz M, Asero R, et al,. ~~Sjogren’s~~Autoimmune ~~syndrome:~~chronic aspontaneous ~~systemic~~urticaria. ~~autoimmune~~J ~~disease,~~Allergy Clin ~~Exp Med~~Immunol. 2022; 22149(16):1819-1831. ~~9–25~~doi:10.1016/j.jaci.2022.04.010

5. ~~Mariette~~Kolkhir, ~~Primary~~P., ~~Sjogren’s~~Giménez-Arnau, ~~symptoms~~A.M., ~~New~~Kulthanan, ~~England~~K. ~~Journal~~et ofal. ~~Medecine,~~Urticaria. ~~2018~~Nat Rev Dis Primers. 8, ~~378;~~61 (2022). https://doi.org/10.1038/s41572-022-00389-z

6. ~~VAY736~~Mendes-Bastos P, ~~Department~~Brasileiro ofA, ~~health~~Kolkhir ~~and~~P, ~~human~~et ~~Services,~~al. ~~Fast~~Bruton's ~~Track~~tyrosine ~~Designation,~~kinase USinhibition-An ~~Food~~emerging ~~and~~therapeutic ~~Drug~~strategy ~~Administration,~~in ~~2025~~immune-mediated dermatological conditions. Allergy. 2022;77(8):2355-2366.

7. ~~ClinicalTrials~~Maurer M, Costa C, Gimenez Arnau A, et al.~~gov~~ ~~NCT05350072~~Antihistamine-resistant ~~[Last~~chronic ~~accessed~~spontaneous urticaria remains undertreated: ~~August~~2-year ~~2025]~~data from the AWARE study. Clin Exp Allergy. 2020;50:1166-1175. doi: 10.1111/cea.13716

8. ~~ClinicalTrials~~Friedman A, Kwatra SG, Yosipovitch G.~~gov~~ ~~NCT0539214~~A ~~[Last~~Practical ~~accessed~~Approach to Diagnosing and Managing Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2024;14(6):1371-1387. ~~August~~doi: ~~2025]~~10.1007/s13555-024-01173-5

9. ~~ClinicalTrials~~Mendelson M, Bernstein J, Gabriel S, et al.~~gov~~ ~~NCT05653219~~Patient-reported ~~[Last~~impact ~~accessed:~~of ~~August~~chronic ~~2025]~~urticaria compared with psoriasis in the United States. J Dermatolog Treat. 2017; 28(3):229-236. doi:10.1080/09546634.2016.1227421

10. ~~ClinicalTrials~~Maurer M, Abuzakouk M, Bérard F, et al.~~gov~~ ~~NCT05639114~~The ~~[Last~~burden ~~accessed~~of chronic spontaneous urticaria is substantial: ~~August~~Real-world ~~2025]~~evidence from ASSURE-CSU. Allergy. 2017;72(12):2005-2016. doi:10.1111/all.13209

11. ~~ClinicalTrials~~Balp M-M, Krupsky K, Balkaran BL, et al.~~gov~~ ~~NCT05126277~~Oral ~~[Last~~presentation ~~accessed~~at: ~~August~~European ~~2025]~~Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2023; June 9–11, 2023; Hamburg, Germany.

12. ~~ClinicalTrials~~Maurer M, Raap U, Staubach P, et al.~~gov~~ ~~NCT05648968~~Antihistamine-resistant ~~[Last~~chronic ~~accessed~~spontaneous urticaria: ~~August~~1-year ~~2025]~~data from the AWARE study. Clin Exp Allergy.2019; 49: 655–662. https://doi.org/10.1111/cea.13309

13. ~~ClinialTrials~~Metz M, Giménez-Arnau A, Hide M, et al.~~gov~~ ~~NTC06470048~~Long-term ~~[Last~~efficacy ~~accessed:~~and ~~August~~safety ~~2025]~~of remibrutinib in patients with chronic spontaneous urticaria in the Phase 3 REMIX-1 and REMIX-2 studies. Presented as a late oral abstract session on clinical trials at EAACI 2024; May 31-June 3, 2024; Valencia, Spain.

~~14.~~# ~~Phase~~# 2 safety and efficacy of subcutaneous (s.c.) dose ianalumab (VAY736; Anti-BAFFR mAB) administered monthly over 28 weeks in patients with Systemic Lupus Erythematosus (SLE) of moderate-to-severe activity, ACR congress, available at : Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity - ACR Meeting Abstracts [Last accessed: August 2025]#

~~15.~~Novartis AMedia Phase 2 Study of ianalumab in patients with primary immune thrombocytopenia previously treater with at least two lines of therapy, EHA congress, available at: EHA Library - The official digital education library of European Hematology Association (EHA) [Last accessed: August 2025]Relations

~~16. Novartis to strengthen oncology pipeline with agreement to acquire Morphosys [AG Press release]. [Press release]. Available at~~E-mail: ~~Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share or an aggregate of EUR 2~~media.~~7bn in cash | Novartis [Last accessed: August 2025]~~relations@novartis.com

~~17.~~Novartis ~~ClinicalTrials.gov~~Investor ~~NCT05985915 [Last accessed: August 2025]~~Relations

~~18.~~Central ~~Maleki~~investor ~~Fischbach-~~relations M,line: et+41 ~~al,~~61 ~~Manifestations~~324 ~~and management of Sjogren’s disease, Arthritis Res Ther. 2024;26(1):43~~7944

~~19.~~E-mail: ~~Kerry Gairy et al, Burden of illness among subgroups of px with primary SjD and systemic involvement, Rheumatology 2021, Volume 60, Issue 4, April 2021, Pages 1871–1881~~investor.relations@novartis.com

20. Conrad N, et al, Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 millions individuals in the UK, Lancet. 2023;401(10391):1878-1890;

21. Narváez J et al, Prevalence of Sjogren’s syndrome in the general adult population in Spain: estimating the proportion of undiagnosed cases, Sci Rep. 2020;10(1):10627

Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

SIGNATURES

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: August 11, 2025	By:	/s/ PAUL PENEPENT
Date: September 30, 2025	By:	/s/ PAUL PENEPENT
	Name:	Paul Penepent
	Title:	Head of Financial Reporting and Accounting

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