Category: 3. Business

Italians are addicted to their cars. In fact, the bel paese has among the highest car ownership in Europe, ranking just behind Poland and Luxembourg, according to the European Automobile Manufacturers’ Association. All of which makes it difficult for a new mobility player to break into a market so attached to their precious vehicles. 

But that’s not the only problem. Italy hasn’t always welcomed mobility upstarts with open arms. With taxi licenses tightly controlled, Euractiv has described the country’s taxi lobby as “mafia-like”. Foreign players such as Uber and Bolt have struggled to gain ground due to stringent regulations. The former only operates its premium Black service in Milan and Rome, and it costs more than a conventional taxi.

Despite the challenging environment, it’s clear that Italy needs more services that provide affordable, viable alternatives to private cars. A flexible service that arrives directly to a user could be key in a nation with a rapidly ageing, less mobile population. That’s where Wayla, a point-to-point van ridesharing service, comes in.

Operating in Milan since 2024, the €1.2m that Wayla recently raised through crowdfunding might be small change compared to global mobility giants. But it shows solid proof of public interest. Could this be the start of an Italian mobility revolution? Monocle spoke to Wayla’s co-founder and chief strategy officer, Mario Ferretti, to find out.

What market dynamics sparked the idea for Wayla, and how are you positioning yourself within Italy’s mobility landscape?
Mario Ferretti: Italy is peculiar when it comes to urban mobility. There’s a structural supply-demand gap, so we need new alternatives to move around our cities – and that’s where Wayla comes in. We are importing the idea to the country and defining it in a way that best fits our culture and is compliant with Italian laws. 

We are currently active in Milan. The system is simple: you download the app, sign up and then you can request a point-to-point ride in the urban area. Once requested, a van of ours will come and pick you up. During the ride, other users can join the journey, making it a cheaper option than other alternatives.

Italy has historically been a challenging market for mobility innovators, particularly due to the taxi lobby’s power and its resistance to foreign ride-hailing competitors. How has Wayla navigated this so far?
We are completely compliant with Italian laws, and we are an Italian startup with Italian employees. So our story is different from those of foreign companies. In a political sense, that’s probably why the market has been more welcoming to us than some of the other players in the past. Still, we are bringing competition where it’s needed – and it’s important to do so. We believe there’s room for everyone. There’s a huge and growing demand in Italy from both residents and tourists. Alternatives are needed.

A similar ride-pooling initiative, Moia, recently ceased operations in Hanover. What strategic or operational lessons have you taken from that example as you expand across Italy?
You need to have a clear vision. Moia is more focused on becoming a tech company [than us] and also more focused on providing autonomous vehicles. That’s growing in Italy as well, albeit at a slower rate than in Germany. Germany’s competitive landscape is also different from Italy’s. We have more space to grow here, and we are already doing well in Milan. We are planning to expand into many other cities, where both the municipalities and other private players are calling for us to go. We are pioneers in this country, so we also expect other players to follow us to the market, which is fine. We can grow together. 

How central are electric vehicles to Wayla’s business model?
We are growing a fleet of electric vehicles. We think it’s essential, and not greenwashing. Our vision is to be a sustainable model for urban transportation. We are already using EVs and we will be doing so more in the future. Italy is a bit lagging when it comes to electrification but our role as a mobility player is to push and invest in the decarbonisation of our fleet and that’s what we’re doing. 

You’re right that Italy is often seen as lagging in the adoption of new technology. How are you working with that perception? 
There’s certainly much to do when it comes to communicating the right things, even beyond our country. It’s the responsibility of everyone and anyone in the ecosystem. We need to attract talent, investments and ideas from abroad. There is room to innovate and there is space to disrupt. That’s what we are trying to do with Wayla – and that’s what’s needed for the future of our country.

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• 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.