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

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-- 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 disease(1). 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 disease(6).

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(R) (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 https://edge.media-server.com/mmc/p/imvutich/.

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 Abstract #LB24

activity in patients with Sjögren's Disease: Oral presentation

Efficacy and safety results from two global Phase Oct. 29, 9:15 am -- 9:30 am CST

3, randomized, placebo-controlled double-blind studies

(NEPTUNUS-1 and NEPTUNUS-2)

---------------------- ------------------------------------------------------------ ----------------------------------

Sjögren's disease Evaluation of the dual mode of action of Ianalumab Abstract #2296

(VAY736) in the circulation and salivary gland tissue Poster presentation

of patients with Sjögren's Disease: Results from Oct. 28, 10:30 am -- 12:30 pm CST

a Phase 2 mechanistic study

---------------------- ------------------------------------------------------------ ----------------------------------

Sjögren's disease Ianalumab's dual mode of action: targeting B cells Abstract #0903

through enhanced B cell depletion and blockade of Poster presentation

B cell activating factor receptor signaling Oct. 27, 10:30 am -- 12:30 pm CST

---------------------- ------------------------------------------------------------ ----------------------------------

Systemic lupus Achieving sustained lupus low disease activity state Abstract #0801

erythematosus and remission with ianalumab (VAY736) in patients Oral presentation

with systemic lupus erythematosus: A post hoc analysis Oct. 26, 1:00 pm -- 1:15pm CST

from a phase II study

---------------------- ------------------------------------------------------------ ----------------------------------

Rapcabtagene autoleucel

------------------------------------------------------------------------------------------------------------------------

Systemic lupus Biomarker data from an open-label, Phase 1/2 Study Abstract #2696

erythematosus for YTB323 (Rapcabtagene Autoleucel, a rapidly manufactured Oral Presentation

CD19 CAR-T therapy) suggest reset of the B Cell compartment Oct. 29, 12:15pm -- 12:30 pm CST

in severe refractory SLE

---------------------- ------------------------------------------------------------ ----------------------------------

Cosentyx (secukinumab)

------------------------------------------------------------------------------------------------------------------------

Psoriatic arthritis Comparison of incidence of psoriatic arthritis in Abstract #2689

patients with psoriasis treated with interleukin-17 Oct. 29, 12:15pm -- 12:30 pm CST

inhibitors vs interleukin-23 inhibitors, interleukin-12/23

inhibitors, and tumor necrosis factor inhibitors in

real-world practice: a retrospective study

---------------------- ------------------------------------------------------------ ----------------------------------

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

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