Novartis to Present Late-Breaking Phase III Data on Ianalumab and New CAR-T Insights at ACR 2025, Advancing Leadership in Autoimmune Disease Research

Novartis to Present Late-Breaking Phase III Data on Ianalumab and New CAR-T Insights at ACR 2025, Advancing Leadership in Autoimmune Disease Research

(IN BRIEF) Novartis will present new data from 27 abstracts at the 2025 American College of Rheumatology (ACR) Convergence, featuring late-breaking Phase III results from the NEPTUNUS-1 and NEPTUNUS-2 trials of ianalumab in Sjögren’s disease, which could become the first targeted therapy for this condition. Additional presentations include biomarker findings from a Phase 1/2 study of rapcabtagene autoleucel (YTB323), a novel CAR-T cell therapy for systemic lupus erythematosus, and new real-world data on Cosentyx in psoriatic arthritis. Dr. Angelika Jahreis emphasized Novartis’ mission to advance transformative therapies for autoimmune diseases. The company will also hold a virtual investor event on October 30 to discuss progress in its immunology pipeline.

(PRESS RELEASE) BASEL, 27-Oct-2025 — /EuropaWire/ —  Novartis is set to showcase groundbreaking new data across its Immunology portfolio at the 2025 American College of Rheumatology (ACR) Convergence, reaffirming its leadership in advancing treatments for complex autoimmune diseases. The company will present 27 abstracts—both company- and investigator-sponsored—including late-breaking Phase III results from the NEPTUNUS-1 and NEPTUNUS-2 studies evaluating ianalumab in Sjögren’s disease. These pivotal findings highlight the potential of ianalumab to become the first targeted therapy for this widespread rheumatic condition, which currently has no FDA-approved treatment options.

In addition to the ianalumab results, Novartis will present new biomarker data from its ongoing Phase 1/2 trial of rapcabtagene autoleucel (YTB323), an investigational CAR-T cell therapy for severe, refractory systemic lupus erythematosus (SLE). This data provides further insight into how YTB323 may induce an “immune reset” by targeting the B cell compartment, offering a potential new therapeutic approach for patients with limited treatment options.

“Our data at this year’s ACR demonstrate how Novartis continues to lead in scientific innovation for autoimmune diseases,” said Dr. Angelika Jahreis, Global Head of Development, Immunology at Novartis. “Autoimmune diseases are among the most challenging and life-altering conditions. We are deeply committed to developing transformative medicines that can redefine care for millions of patients around the world.”

Beyond these highlights, Novartis will also present new findings on Cosentyx® (secukinumab), including real-world data in psoriatic arthritis and analyses comparing interleukin inhibitor classes. Together, the portfolio showcases the company’s broad immunology expertise spanning rheumatology, dermatology, and allergy, with innovation driven by small molecules, biologics, and next-generation CAR-T therapies.

Following ACR, Novartis will host a virtual investor event on October 30, 2025, at 11:30 a.m. ET to discuss progress across its immunology pipeline.

Through its expanding body of research, Novartis continues to pioneer therapies that address the root causes of autoimmune diseases—aiming not only to treat symptoms but to fundamentally reset immune pathways and transform patient outcomes.

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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.

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References

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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/
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