Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU)

• Rhapsido demonstrated statistically significant and clinically meaningful symptom control in twice as many patients vs placebo¹, with favorable safety profile and no observed liver safety concerns2

• With global CIndU prevalence of 29 million^3,4; greater than 50% of patients experience significant disease burden despite treatment with H1-antihistamines; no approved targeted therapies exist5,6

• Rhapsido is under FDA review for CIndU symptomatic dermographism subtype; additional submissions to health authorities globally to continue in 2026
  

Basel, June 12, 2026 – Novartis today presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido^®  (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial⁷. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines⁷.

“Chronic inducible urticaria (CIndU) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité–Universitätsmedizin Berlin, Germany. “The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need.”

The three most prevalent CIndU subtypes are symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria, with SD being the most common⁸. Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Rhapsido for the treatment of SD subtype and will continue additional filings to health authorities globally throughout 2026. Rhapsido is approved for use in the U.S., European Union, China and several other countries for the treatment of chronic spontaneous urticaria (CSU), in adult patients with inadequate response to H1-antihistamines.

“Rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. This is a major step forward for CIndU patients who have limited options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “The CIndU data presented today are consistent with Rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate Novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.”

Primary endpoint results at Week 12 in the RemIND trial¹

*Proportion of participants with complete response to FricTest® (TFS=0), TempTest® (CTT<4°C), or pulse-controlled ergometry test at week 12 (itch NRS score=0).

About Rhapsido^®
Rhapsido (remibrutinib) is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives (wheals) and swelling^9-11. By reducing histamine release, Rhapsido helps relieve the symptoms of CIndU^2,12. In the U.S., European Union, China, South Korea and several other countries, Rhapsido is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines. Remibrutinib is being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio^13-16.

About the RemIND trial
The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of Rhapsido in adults with CIndU inadequately controlled by H1-antihistamines¹⁷. The primary endpoint of RemIND is the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes¹⁷. The secondary endpoints were change from baseline to the same endpoints at weeks 2 and 12; and the proportion of participants with complete response at weeks 2 and 24.

About Chronic Inducible Urticaria (CIndU)
CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide^3,4. CIndU differs from chronic spontaneous urticaria (CSU), which has no specific triggers¹⁹. CIndU places a significant burden on daily life, with many patients cycling through antihistamines without adequate relief²⁰. With no approved targeted therapies available today, there remains a clear and longstanding gap in effective treatment options for these patients^20,21.

The most prevalent CIndU subtype, symptomatic dermographism, manifests with itchy hives caused by shear force on skin, such as friction or light scratching, which appear in less than 5 minutes after contact and usually last 30 minutes¹⁸. Cold urticaria occurs after skin exposure to cold, leading to wheals or angioedema that develop within minutes after exposure and are usually limited to exposed areas¹⁸. Cholinergic urticaria manifests with characteristic small, punctate hives triggered by active or passive heating of the body, including exercise, strong emotions, or bathing in hot water¹⁸.

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.

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 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.

References

1. Mosnaim G, Giménez-Arnau A, Ensina LF, et al. Remibrutinib demonstrated superior efficacy vs placebo and favorable safety in patients with chronic inducible urticaria in the phase 3 REMIND study. Presented as a late abstract at EAACI 2026; June 12-15, 2026; Istanbul, Türkiye. Abstract number 100213
2. Data on files
3. Maurer M, et al. How to approach Chronic Inducible Urticaria, The Journal of Allergy and Clinical Immunology, 2018, Volume 6, Issue 4, Pages 1119-1130
4. World Population Prospects, Department of Economic and Social Affairs Population Division, United Nations. Available from: https://population.un.org/wpp/downloads?folder=Standard%20Projections&group=Population [Last accessed: February 2026]
5. Pereira ARF, et al. Einstein (Sao Paulo). 2020;18:eAO5175.
6. Kocatürk E, et al. J Dermatol Sci. 2017;87(1):60-69
7. Mosnaim G, Giménez-Arnau A, Ensina LF, et al. Remibrutinib demonstrated superior efficacy vs placebo and favorable safety in patients with chronic inducible urticaria in the phase 3 REMIND study. Presented at a late oral abstract session L-OAS03 at EAACI 2026; June 12-15, 2026; Istanbul, Türkiye. Abstract number 100213.
8. Kolkhir P, et al. Urticaria. Nat Rev Dis Primers. 2022;8(61)
9. Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506. 
10. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (remibrutinib), a potent and highly selective covalent inhibitor of Bruton’s Tyrosine Kinase. J Med Chem 2020; 63: 5102-5118. 
11. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565.
12. Patient. Antihistamines. Last updated 12 October 2022. Available from: https://patient.info/allergies-blood-immune/allergies/antihistamines [Last accessed: February 2026].  
13. ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from: https://clinicaltrials.gov/ct2/show/NCT03827798. [Last accessed: February 2026]
14. ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from: https://clinicaltrials.gov/study/NCT05432388 [Last accessed: February 2026].
15. ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from: https://clinicaltrials.gov/study/NCT05147220 [Last accessed: February 2026].
16. ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from: https://clinicaltrials.gov/study/NCT05156281 [Last accessed: February 2026].
17. ClinicalTrials.gov. NCT05976243. A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines. Available from: https://clinicaltrials.gov/study/NCT05976243 [Last accessed: February 2026].
18. Pozderac I, et al. Chronic inducible urticaria: classification and prominent features of physical and non-physical types. Acta Dermatovenerol Alp Pannonica Adriat. 2020;29(3):141–8
19. Zuberbier et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis and management of urticaria. Allergy.2022;77(3):734–66
20. M Kern B, et al. Physician estimation of the prevalence and clinical impact of chronic urticaria: results of the global, multicenter UCARE CU-PAPER study, Frontiers in allergy, 2026, volume 6:1732893
21. Munoz M, et al. New insights into chronic inducible urticaria. Current Allergy and Asthma Reports, 2024 volume 24, 457-469 

# # #