Late-breaking positive Phase III data from ianalumab NEPTUNUS-1 and NEPTUNUS-2 trials in Sj\u00f6gren\u2019s disease to be presented Biomarker data informing use of investigational CAR-T cell therapy rapcabtagene autoleucel (YTB323) in systemic lupus erythematosus also to be presentedData underscore Novartis commitment to advance innovative medicines for complex, difficult-to-treat autoimmune diseases with high unmet needNovartis to hold virtual investor event following ACR highlighting immunology pipeline progress <\/p>\n
Basel, October 25, 2025 \u2013 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 Sj\u00f6gren\u2019s 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 indications2,3.<\/p>\n
\u201cOur data at this year\u2019s 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 Sj\u00f6gren\u2019s,\u201d said Angelika Jahreis, Global Head, Development, Immunology, Novartis. \u201cAutoimmune 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.\u201d<\/p>\n
Ianalumab is an investigational medicine that has the potential to become the first targeted therapy for Sj\u00f6gren\u2019s disease, an area of high unmet need with no FDA-approved treatments4,5. Sj\u00f6gren\u2019s disease affects millions of people globally and is the second most prevalent rheumatic disease6. <\/p>\n
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 reset7-9. Further presentations will feature real-world data on Cosentyx\u00ae (secukinumab) in psoriatic arthritis, and new insights into the dual mode of action of ianalumab.<\/p>\n
Investor call on Novartis Immunology pipeline\u00a0 Key abstracts accepted by ACR include:<\/p>\n Molecule\/disease state Abstract title Abstract number\/ presentation details\u00a0\u00a0\u00a0\u00a0\u00a0 Ianalumab Sj\u00f6gren\u2019s disease<\/p>\n \u00a0 <\/p>\n Ianalumab demonstrates significant reduction in disease activity in patients with Sj\u00f6gren\u2019s Disease: Efficacy and safety results from two global Phase 3, randomized, placebo-controlled double-blind studies (NEPTUNUS-1 and NEPTUNUS-2)\u00a0 Abstract #LB24 \u00a0 <\/p>\n Sj\u00f6gren\u2019s disease<\/p>\n \u00a0 <\/p>\n Evaluation of the dual mode of action of Ianalumab (VAY736) in the circulation and salivary gland tissue of patients with Sj\u00f6gren\u2019s Disease: Results from a Phase 2 mechanistic study Abstract #2296 \u00a0 <\/p>\n Ianalumab\u2019s dual mode of action: targeting B cells through enhanced B cell depletion and blockade of B cell activating factor receptor signaling Abstract #0903 \u00a0 <\/p>\n 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\u00a0 Abstract #2689 \u00a0 <\/p>\n About Novartis Immunology\u00a0 With a growing legacy of first-in-class innovation across Rheumatology, Dermatology and Allergy, and a diverse industry-leading pipeline, we\u2019re committed to shaping what\u2019s 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.\u00a0<\/p>\n We\u2019re not just treating autoimmune diseases. We\u2019re reimagining medicine, together.<\/p>\n Product information Disclaimer About Novartis\u00a0 Reimagine medicine with us: Visit us at https:\/\/www.novartis.com<\/a> and connect with us on\u00a0LinkedIn<\/a>, Facebook<\/a>, X\/Twitter<\/a> and Instagram<\/a>.<\/p>\n References<\/p>\n Novartis. Data on file.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\/<\/a>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\/<\/a>Dorner T, et al. Safety and Efficacy of ianalumab in patients with Sjogren\u2019s disease: 52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study. Arthritis and Rheumatology. 2025; 77(5):560-570 Negrini S, et al. Sjogren\u2019s syndrome: a systemic autoimmune disease, Clin Exp Med. 2022; 22(1): 9-25 National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Selected Immune Disorders and Disability. Sjogren\u2019s Disease\/Syndrome. Accessed September 11, 2025. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK584486\/<\/a>\u00a0 ClinicalTrials.gov NCT05798117<\/a> [Last accessed: September 2025] ClinicalTrials.gov NCT06665256<\/a> [Last accessed: September 2025] ClinicalTrials.gov NCT06655896<\/a> [Last accessed: September 2025] <\/p>\n # # #<\/p>\n
Following the conclusion of ACR, Novartis will host a conference call for investors to provide updates on the company\u2019s Immunology pipeline on Thursday, October 30, 2025, at 11:30 a.m. ET. Details can be found here<\/a>.<\/p>\n
Oral presentation
Oct. 29, 9:15 am \u2013 9:30 am CST<\/p>\n
Poster presentation
Oct. 28, 10:30 am \u2013 12:30 pm CST Sj\u00f6gren\u2019s disease<\/p>\n
Poster presentation
Oct. 27, 10:30 am \u2013 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 \u2013 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 \u2013 12:30 pm CST Cosentyx (secukinumab) Psoriatic arthritis<\/p>\n
Oct. 29, 12:15pm \u2013 12:30 pm CST<\/p>\n
At Novartis, we\u2019re advancing bold science for autoimmune diseases, where meaningful therapeutic progress has long stalled.<\/p>\n
For full prescribing information, including approved indications and important safety information about marketed products, please visit\u00a0https:\/\/www.novartis.com\/about\/products<\/a><\/p>\n
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Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people\u2019s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.<\/p>\n