Novartis showcases significant immunology advancements in ACR congress with new data in complex autoimmune diseases

• Late-breaking positive Phase III data from ianalumab NEPTUNUS-1 and NEPTUNUS-2 trials in Sjögren’s disease to be presented
  
  
• Biomarker data informing use of investigational CAR-T cell therapy rapcabtagene autoleucel (YTB323) in systemic lupus erythematosus also to be presented
  
  
• Data underscore Novartis commitment to advance innovative medicines for complex, difficult-to-treat autoimmune diseases with high unmet need
  
  
• Novartis to hold virtual investor event following ACR highlighting immunology pipeline progress

Basel, October 25, 2025 – Novartis announced today plans to present data from 27 company- or investigator-sponsored abstracts across its Immunology portfolio and pipeline at the 2025 American College of Rheumatology (ACR) Convergence. Data to be presented include late-breaking pivotal Phase III results from the replicate NEPTUNUS-1 and NEPTUNUS-2 trials evaluating ianalumab in Sjögren’s disease¹. New biomarker data from an ongoing Phase 1/2 study of rapcabtagene autoleucel in severe refractory systemic lupus erythematosus will also be presented, along with Cosentyx data in multiple rheumatology indications^2,3.

“Our data at this year’s ACR demonstrate that Novartis is at the forefront of scientific innovation and is developing medicines for some of the most challenging autoimmune diseases, such as Sjögren’s,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis. “Autoimmune diseases are often devastating and life-limiting. We are committed to developing new therapies with the potential to transform the standard of care for the millions who continue to suffer from rheumatic diseases.”

Ianalumab is an investigational medicine that has the potential to become the first targeted therapy for Sjögren’s disease, an area of high unmet need with no FDA-approved treatments^4,5. Sjögren’s disease affects millions of people globally and is the second most prevalent rheumatic disease⁶.

Additional presentations include data for rapcabtagene autoleucel, a novel one-time investigational CAR-T cell therapy being evaluated across several refractory autoimmune disease for its potential to induce an immune reset^7-9. Further presentations will feature real-world data on Cosentyx^® (secukinumab) in psoriatic arthritis, and new insights into the dual mode of action of ianalumab.

Investor call on Novartis Immunology pipeline 
Following the conclusion of ACR, Novartis will host a conference call for investors to provide updates on the company’s Immunology pipeline on Thursday, October 30, 2025, at 11:30 a.m. ET. Details can be found here.

Key abstracts accepted by ACR include:

Molecule/disease state	Abstract title	Abstract number/ presentation details
Ianalumab
Sjögren’s disease	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)	Abstract #LB24 Oral presentation Oct. 29, 9:15 am – 9:30 am CST
Sjögren’s disease	Evaluation of the dual mode of action of Ianalumab (VAY736) in the circulation and salivary gland tissue of patients with Sjögren’s Disease: Results from a Phase 2 mechanistic study	Abstract #2296 Poster presentation Oct. 28, 10:30 am – 12:30 pm CST
Sjögren’s disease	Ianalumab’s dual mode of action: targeting B cells through enhanced B cell depletion and blockade of B cell activating factor receptor signaling	Abstract #0903 Poster presentation Oct. 27, 10:30 am – 12:30 pm CST
Systemic lupus erythematosus	Achieving sustained lupus low disease activity state and remission with ianalumab (VAY736) in patients with systemic lupus erythematosus: A post hoc analysis from a phase II study	Abstract #0801 Oral presentation Oct. 26, 1:00 pm – 1:15pm CST
Rapcabtagene autoleucel
Systemic lupus erythematosus	Biomarker data from an open-label, Phase 1/2 Study for YTB323 (Rapcabtagene Autoleucel, a rapidly manufactured CD19 CAR-T therapy) suggest reset of the B Cell compartment in severe refractory SLE	Abstract #2696 Oral Presentation Oct. 29, 12:15pm – 12:30 pm CST
Cosentyx (secukinumab)
Psoriatic arthritis	Comparison of incidence of psoriatic arthritis in patients with psoriasis treated with interleukin-17 inhibitors vs interleukin-23 inhibitors, interleukin-12/23 inhibitors, and tumor necrosis factor inhibitors in real-world practice: a retrospective study	Abstract #2689 Oct. 29, 12:15pm – 12:30 pm CST

About Novartis Immunology 
At Novartis, we’re advancing bold science for autoimmune diseases, where meaningful therapeutic progress has long stalled.

With a growing legacy of first-in-class innovation across Rheumatology, Dermatology and Allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. From small molecules to biologics and CAR-T cell therapy, our innovation is powered by cutting-edge science, focused on where we can have the greatest impact on patient outcomes and supported by strong collaboration across the healthcare ecosystem. 

We’re not just treating autoimmune diseases. We’re reimagining medicine, together.

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,” “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. Data on file.
2. Morand E, et al. Biomarker Data From an Open-Label, Phase 1/2 Study for YTB323 (Rapcabtagene Autoleucel, a Rapidly Manufactured CD19 CAR-T Therapy) Suggest Reset of the B Cell Compartment in Severe Refractory SLE. Abstract presented at ACR Convergence 2025. Accessed September 19, 2025. https://acrabstracts.org/abstract/biomarker-data-from-an-open-label-phase-1-2-study-for-ytb323-rapcabtagene-autoleucel-a-rapidly-manufactured-cd19-car-t-therapy-suggest-reset-of-the-b-cell-compartment-in-severe-refractory-sle/
3. Armstrong A, et al. Comparison of Incidence of Psoriatic Arthritis in Patients With Psoriasis Treated With Interleukin-17 Inhibitors vs Interleukin-23 Inhibitors, Interleukin-12/23 Inhibitors, and Tumor Necrosis Factor Inhibitors in Real-World Practice: A Retrospective Study. Abstract presented at ACR Convergence 2025. Accessed September 19, 2025. https://acrabstracts.org/abstract/comparison-of-incidence-of-psoriatic-arthritis-in-patients-with-psoriasis-treated-with-interleukin-17-inhibitors-vs-interleukin-23-inhibitors-interleukin-12-23-inhibitors-and-tumor-necrosis-factor-i/
4. Dorner T, et al. Safety and Efficacy of ianalumab in patients with Sjogren’s disease: 52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study. Arthritis and Rheumatology. 2025; 77(5):560-570
5. Negrini S, et al. Sjogren’s syndrome: a systemic autoimmune disease, Clin Exp Med. 2022; 22(1): 9-25
6. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Selected Immune Disorders and Disability. Sjogren’s Disease/Syndrome. Accessed September 11, 2025. https://www.ncbi.nlm.nih.gov/books/NBK584486/
7. ClinicalTrials.gov NCT05798117 [Last accessed: September 2025]
8. ClinicalTrials.gov NCT06665256 [Last accessed: September 2025]
9. ClinicalTrials.gov NCT06655896 [Last accessed: September 2025]
   
   

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