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WKN: 904278 | ISIN: CH0012005267 | Ticker-Symbol: NOT
Tradegate
23.02.26 | 09:15
138,20 Euro
+0,13 % +0,18
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NOVARTIS AG Chart 1 Jahr
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138,18138,2809:16
138,20138,2209:16
GlobeNewswire (Europe)
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Novartis Pharma AG: Novartis presents Rhapsido (remibrutinib) data at AAAAI, showing potential beyond chronic spontaneous urticaria (CSU)

  • Analyses from REMIX-1 & -2 studies on CSU disease control and early symptom relief will be presented

  • Phase II data evaluating safety and efficacy results of remibrutinib for treatment of peanut allergy to be featured in an oral session

  • Phase III program in food allergy (FA) planned for H2 2026

Basel, February 23, 2026 - Novartis will present data from five key abstracts evaluating the highly selective oral Bruton's tyrosine kinase inhibitor (BTKi) Rhapsido (remibrutinib) in chronic spontaneous urticaria (CSU) and as an investigational therapy for peanut allergy at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, PA, from February 27 to March 2, 2026. These presentations provide more evidence on the use of Rhapsido in CSU, as well as its potential in other indications and highlight Novartis commitment to addressing unmet needs in patients with immune-mediated diseases.

New analyses on the impact of Rhapsido on disease control and early symptom relief from the Phase III REMIX-1 and REMIX-2 trials in CSU will be presented. Additionally, the first presentation of Phase II FA data for remibrutinib, focusing on IgE-mediated peanut allergy, will be featured in an oral session. Plans are in progress to begin the Phase III program in FA in 2026.

"These food allergy (FA) data further strengthen the evidence supporting remibrutinib as a novel, well-tolerated, oral option for patients with allergic and immune-mediated diseases, complementing the recent FDA approval in chronic spontaneous urticaria (CSU) and underscoring its broader therapeutic potential," said Angelika Jahreis, Global Head, Immunology Development, Novartis. "Our priority is advancing therapies for patients who have few alternatives and expanding the reach of innovative medicines to transform care across multiple, high-need disease areas."

Regulatory reviews for remibrutinib for the treatment of CSU are underway in several regions, including the European Union and Japan.

In addition to FA, remibrutinib is in clinical development for chronic inducible urticaria (CIndU) and hidradenitis suppurativa (HS). FDA submission for remibrutinib in symptomatic dermographism, the most prevalent type of CIndU, was completed in Q4 2025. Additionally, positive topline results were announced for the remaining two arms of the CIndU Phase III RemIND trial. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented at upcoming medical congresses.

Abstracts accepted by AAAAI include:

Abstract TitleAbstract Number/Presentation Details

Efficacy and safety of remibrutinib, a Bruton's tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergyAbstract #563
Oral Presentation
Saturday, February 28

2:45-2:55 PM EST

Remibrutinib Decreases Urticaria Disease Activity Leading To Improved Disease Control: An Analysis From The REMIX-1/-2 studiesAbstract #822
Poster
Sunday, March 1
3:30-5:00 PM EST

Remibrutinib Provides Fast Symptom Relief Within the First Week of Treatment in Chronic Spontaneous Urticaria, as Measured by Daily Urticaria Activity Score: Pooled REMIX-1/-2 StudiesAbstract #039
Poster
Friday, February 27
2:45-3:45 PM EST

Patients with Chronic Spontaneous Urticaria (CSU) in the US (United States): Health Care Resource Utilization (HCRU) by Level of Disease Control Abstract #021
Poster
Friday, February 27
2:45-3:45 PM EST


A Novel Panel of Autoantibodies May Assist In The Molecular Diagnosis of CSU Abstract #022
Poster
Friday, February 27
2:45-3:45 PM EST

About Novartis Immunology
At Novartis, we're advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our 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.

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 more than 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.


# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

© 2026 GlobeNewswire (Europe)
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