Category: 3. Business

• NEPTUNUS-1 and NEPTUNUS-2 achieved primary objective of reduced disease activity and provided clinically meaningful benefit¹ 
• Data showed consistent improvements across secondary outcome measures, and a favorable safety profile¹ 
• Novartis plans to submit to health authorities globally in early 2026
• If approved, ianalumab could become first targeted treatment for this heterogeneous, systemic autoimmune disease

Basel, October 29, 2025 – Novartis today presented new ianalumab data in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease², at a late-breaker presentation during the American College of Rheumatology Convergence congress¹.

Ianalumab 300 mg monthly delivered a clinically meaningful benefit in the global NEPTUNUS-1 and NEPTUNUS-2 Phase III trials, showing both improvement in disease activity and reductions in patient burden¹. Compared to placebo, ianalumab achieved a numerically greater reduction in disease activity by Week 16 with improvements sustained through Week 52 as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI)¹. 

“Sjögren’s disease is a debilitating autoimmune condition affecting multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma – that together may create a substantial disease burden,” says Professor Xavier Mariette, Head of Department of Immuno-Rheumatology, Bicêtre Hospital, Assistance Publique – Hôpitaux de Paris, Paris-Saclay University, France. “The NEPTUNUS trials were the first Phase III studies in Sjögren’s in which a treatment significantly improved disease activity and demonstrated that ianalumab has the potential to provide a clinically meaningful benefit to patients.”

Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and also inhibits their activation and survival via BAFF-R blockade³. B-cell dysfunction plays a significant role in Sjögren’s disease by causing an autoimmune response that leads to inflammation and tissue damage^4-6. 

“Today’s results reinforce our confidence that ianalumab has the potential to transform the treatment of this complex disease where no targeted medications currently exist,” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “We look forward to working with health authorities globally to bring this innovation to people with Sjögren’s disease, the second most prevalent rheumatic autoimmune disease.” 

NEPTUNUS study outcomes from 219 trial sites in 35 countries
The replicate NEPTUNUS trials showed statistically significant improvement in ESSDAI, the primary endpoint, at week 48 for ianalumab 300 mg monthly¹. Numerical improvements were observed as early as Week 16, which were sustained throughout the study¹. 

Patients receiving ianalumab showed consistent numerical improvements in secondary outcome measures including:

• More patients with ESSDAI low disease activity¹
• Improvement in Physician Global Assessment¹
• Reduction in overall disease burden as early as Week 8 continuing to Week 52 as assessed by Patient Global Assessment¹
• Numerical improvement in dryness, pain and fatigue as assessed by Sjögren’s Syndrome Symptom Diary and EULAR Sjögren’s Syndrome Patient Reported Index¹
• Improvement of stimulated Salivary Flow (sSF) rate and oral dryness vs placebo in patients with sSF>0.4 mL/min at baseline, in a post-hoc analysis¹

Ianalumab 300 mg monthly numerically improved physician- and patient-reported outcomes¹. Nominal significance was observed in NEPTUNUS-1 and the pooled data set for PhGA and PaGA, as well as the number of patients achieving low disease activity based on ESSDAI in the pooled data set¹. The pooled and individual patient-reported secondary outcomes did not reach statistical significance¹.

The trial results showed favorable safety with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies¹.

About NEPTUNUS-1 and NEPTUNUS-2  
The Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, are global, multicenter, pivotal studies evaluating the efficacy and safety of ianalumab in patients with Sjögren’s disease^7,8. These trials were designed to provide comprehensive data on the potential of ianalumab as a targeted treatment for Sjögren’s disease, in patients with active extraglandular disease^3,7,8.  

NEPTUNUS-1 is a randomized, double-blind, 2-arm multicenter Phase III trial (N=275) designed 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.

Patients currently enrolled in the trials have been given the opportunity to continue follow-up in these studies or enter a long-term extension trial that will continue to assess the long-term efficacy and safety of ianalumab⁹.  

Ianalumab (VAY736) is also being investigated for its potential to treat other B-cell driven autoimmune diseases including immune thrombocytopenia (ITP), systemic lupus erythematosus (SLE), lupus nephritis (LN), warm autoimmune hemolytic anemia (wAIHA) and systemic sclerosis (SSc)^3,10-14. Ianalumab originates from an early collaboration with MorphoSys AG, a company which Novartis acquired in 2024¹⁵.

About Sjögren’s disease (previously called Sjögren’s syndrome) 
Sjögren’s disease is a complex, systemic autoimmune disease that causes inflammation and tissue damage, impacting the entire body¹⁶. It primarily affects exocrine glands, leading to excessive dryness, with over 90% of patients experiencing dry eyes and dry mouth^16,17. The disease is heterogenous and inflicts a wide range of symptoms, with patients most commonly experiencing dryness, fatigue and widespread pain, though 30-40% of patients will also show extraglandular organ involvement^18,19. Extraglandular manifestation can be very diverse and can affect skin, musculoskeletal system, kidneys, lungs and other organs¹⁹. The risk of lymphoma is increased in patients with Sjögren’s¹⁸. Sjögren’s affects approximately 0.25% of the population with an estimated 50% undiagnosed ^20-21. Sjögren’s is nine times more common in women than men¹⁶. 

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. Thomas GB, Xavier M, Stephanie F et al. Ianalumab demonstrates significant reduction in disease activity in patients with Sjögren’s Disease: Efficacy and safety results from two global Phase 3, randomized, placebo-controlled double-blind studies (NEPTUNUS-1 and NEPTUNUS-2). Presented at the American College of Rheumatology (ACR) Congress; October 24-29, 2025; Chicago, Illinois 
2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Selected Immune Disorders and Disability. Sjögren’s Disease/Syndrome. [Last accessed: October 2025] https://www.ncbi.nlm.nih.gov/books/NBK584486/ 
3. Dorner T et al, Safety and Efficacy of ianalumab in patients with Sjögren’s disease: 52-week results from a randomized, placebo-controlled, Phase 2b dose-ranging study, Arthritis and Rheumatology 2025, 77(5):560-570 
4. Lee AY, Qi Z, Jackson KJ, et al. Self-reactive B cells are increased in all major stages of peripheral development in Sjögren’s disease. Immunology & Cell Biology 2025; 103: 401-410. 
5. Both T, Dalm VA, van Hagen PM, et al. Reviewing primary Sjögren’s syndrome: beyond the dryness – From pathophysiology to diagnosis and treatment. Int J Med Sci 2017; 14: 191-200. 
6. Cornec D, Devauchelle-Pensec V, Tobón GJ, et al. B cells in Sjögren’s syndrome: from pathophysiology to diagnosis and treatment. J Autoimmun 2012; 39: 161-167. 
7. ClinicalTrials.gov NCT05350072 [Last accessed: October 2025]  
8. ClinicalTrials.gov NCT0539214 [Last accessed: October 2025] 
9. ClinicalTrials.gov NCT05985915 [Last accessed: October 2025] 
10. ClinicalTrials.gov NCT05653219 [Last accessed: October 2025]  
11. ClinicalTrials.gov NCT05639114 [Last accessed: October 2025]  
12. ClinicalTrials.gov NCT05126277 [Last accessed: October 2025]  
13. ClinicalTrials.gov NCT05648968 [Last accessed: October 2025]   
14. ClinicalTrials.gov NTC06470048 [Last accessed: October 2025] 
15. Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys [AG Press release]. [Press release]. Available at: Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share or an aggregate of EUR 2.7bn in cash | Novartis [Last accessed: October 2025]   
16. Negrini S et al, Sjögren’s syndrome: a systemic autoimmune disease, Clin Exp Med. 2022; 22(1): 9–25 
17. Maleki Fischbach-M, et al, Manifestations and management of Sjögren’s disease, Arthritis Res Ther, 2024; 26(1):43 
18. Mariette, Primary Sjögren’s symptoms, New England Journal of Medicine, 2018, 378;10 
19. 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 
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 Sjögren’s syndrome in the general adult population in Spain: estimating the proportion of undiagnosed cases, Sci Rep. 2020;10(1):10627  

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The Japanese auto giant Toyota Motor has denied Donald Trump’s suggestion that it is poised to invest more than $10bn in the United States over the coming years.

On a visit to Japan earlier this week, the US president claimed he had been told that the carmaker was going to be setting up factories “all over” the US “to the tune of over $10bn”.

“Go out and buy a Toyota,” added Trump.

But a senior executive at Toyota – the world’s largest automaker – said that no such explicit promise of investment at that level had been made, although Toyota plans to invest and create new jobs in the US.

The firm held talks with Japanese and American officials ahead of Trump’s visit.

“During the first Trump administration, I think the figure was roughly around $10bn, so while we didn’t say the same scale, we did explain that we’ll keep investing and providing employment as before,” Hiroyuki Ueda told reporters, on the sidelines of the Japan Mobility Show in Tokyo. “So, probably because of that context, the figure of about $10bn came up.”

Toyota “didn’t specifically say that we’ll invest $10bn over the next few years”, Ueda said, adding that the topic of investment did not come up when Akio Toyoda, the firm’s chairman, spoke with Trump at a US Embassy event on Tuesday.

Trump met with Japan’s new prime minister and first female premier, Sanae Takaichi, on Tuesday. He welcomed Takaichi’s pledge to accelerate a military buildup, while also signing deals on trade and rare earths.

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During the visit, Takaichi pledged to realise a “golden age” in relations with the US and to “fundamentally reinforce” her country’s defense posture. The two leaders signed an agreement laying out a framework to secure the mining and processing of rare earths and other minerals.

Reuters contributed reporting.

“If you dial the clock back [to] two decades ago, if you had money and wanted to invest, you would call up your brokers and talk about what stocks there are available,” Bonnie Chan, CEO of Hong Kong Exchanges and Clearing (HKEX), said Monday at the Fortune Global Forum in Riyadh.

“Now, people can get exposure to all sorts of investment opportunities. We’re entering a stage where exchanges are not really competing with one another, but working together.”

Since the first Bitcoin boom in the early 2010s, investors have increasingly explored new investment instruments, such as cryptocurrencies and other digital assets. 

Meanwhile, stock markets are performing well this year, with indices reaching all-time highs, in part due to retail investors piling into buzzy companies and investment fads. On Monday, Chan’s fellow panelists, Saudi Tadawul Group CEO Eng. Khalid Abdullah Al Hussan and Nasdaq vice chairman Bob McCooey, noted that investor appetite was returning globally. 

“The U.S. went through, from the end of 2021, two or three years of tough markets where people couldn’t get public. In 2025, we’re getting some momentum here,” McCooey said, referring to U.S. markets. He added that a growing number of companies want to go public (i.e. list shares for sale on the stock exchange), including private equity firms and government-backed companies.

Al Hussan also pointed to burgeoning investor appetite in Saudi Arabia’s market, noting that in the last three years, the country went from having eight to nine IPOs a year, to around 40 to 45 annually.

Chan, from HKEX, pointed out that Hong Kong’s exchanges have in recent times completed close to 80 IPOs. “We went through a phase in the last few years where there were questions as to the invest-ability of Chinese stocks. But I think we have made a lot of progress,” she said.

She attributed the global rise in IPOs to investors’ desire to diversify their investment and trading strategies, in order to hedge against market volatility from geopolitical uncertainty and new protectionist policies. 

“They want to put their eggs in more than one basket,” she said, adding that Hong Kong has recently seen a return of international investors. “This year, we’ve seen a strong appetite from investors. They want AI, semiconductors, and names in the green technology space.”

Aside from tech, Chan noted a new investment trend, which she called “new consumption.” She cited the latest consumer craze for Labubu dolls, collectible plush toys designed by Hong Kong illustrator Kasing Lung. Pop Mart, which sells Labubu dolls in blind boxes, currently has a market value of over $40 billion.

Carmakers in the EU are “days away” from closing production lines, the industry has warned as a crisis over computer chip supplies from China escalates.

The European Automobile Manufacturers’ Association (ACEA) issued an urgent warning on Wednesday saying its members, which include Volkswagen, Fiat, Peugeot and BMW, were now working on “reserve stocks but supplies are dwindling”.

“Assembly line stoppages might only be days away. We urge all involved to redouble their efforts to find a diplomatic way out of this critical situation,” said its director general, Sigrid de Vries.

Another ACEA member, Mercedes, is now searching globally for alternative sources of the crucial semiconductors, according to its chief executive, Ola Källenius.

The chip shortage is also causing problems in Japan, where Nissan’s chief performance officer, Guillaume Cartier, told reporters at a car show in Tokyo that the company was only “OK to the first week of November” in terms of supply.

Beijing banned exports of Nexperia chips near the start of the month in response to the Dutch government’s decision to take over the Netherlands-headquartered company on 30 September and suspend its Chinese chief executive after the US flagged security concerns.

Last week car companies in the UK, EU and Japan, including brands such as Volvo, Volkswagen, Honda and Nissan, said the ban on exports from Nexperia factories in China could halt production lines.

“The industry is currently working through reserve stocks but supplies are rapidly dwindling. From a survey of our members this week, some are already expecting imminent assembly line stoppages,” de Vries said.

The Nexperia chip ban was a blow to Europe’s car sector, which has already been hit by President Xi Jinping’s decision to reintroduce controls on exports of rare earth exports as part of the escalating trade tensions with the US.

Xi and Donald Trump are expected to sign off on a trade agreement when they meet on the sidelines of a summit in South Korea on Thursday. The proposed deal would pause the export ban on the crucial minerals for a year, but it is unclear if this will also cover deliveries to the EU.

Rare earths, in particular magnets, are used across the car industry for window, door and boot openings, while chips are critical to all electronics in vehicles, ranging from dashboard functions to ignition and transmission systems.

De Vries said while alternative suppliers for chips existed, it could take “months to build up additional capacity”. She said the “industry does not have that long before the worst effects of this shortage are felt”.

A high-level delegation from Beijing will arrive in Brussels on Friday for talks but there are fears the diplomatic tools deployed by the EU in the past months are not as effective as the hardballing used by the US and China.

“We know that all parties to this dispute are working very hard to find a diplomatic solution. At the same time, our members are telling us that part supplies are already being stopped due to the shortage,” de Vries said.

The Dutch government seized control of Nexperia on 30 September, citing lapses in governance. On 4 October, the Chinese ministry of commerce blocked exports of the chipmaker’s products out of China. While most of Nexperia’s semiconductors are produced in Europe, about 70% are packaged in China before distribution.

The company’s Chinese arm has taken steps toward independence and has resumed selling products to domestic Chinese customers.

The sources said the Dutch government believes it can negotiate a resolution with China that will restore the company to a unified Dutch-Chinese structure.