Press Release: Novartis to highlight Rhapsido(R) data across multiple immune-mediated diseases at EAACI Congress 2026

08.06.26 09:00 Uhr

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-- Results from Rhapsido (remibrutinib) pivotal Phase III RemIND trial, the

largest study in chronic inducible urticaria, to be highlighted in

late-breaker oral presentation

-- New Phase IIIb REMIXED extension data in chronic spontaneous urticaria to

provide additional efficacy and safety data for Rhapsido

-- Phase II Rhapsido food allergy dose-response analysis in adults with

IgE-mediated peanut allergy also to be presented

Basel, June 8th, 2026 -- Novartis will present data from 10 abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, spanning Rhapsido(R) (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. Highlights include two late-breaking oral presentations; the Phase III RemIND trial for Rhapsido in chronic inducible urticaria (CIndU) and extension data from the Phase IIIb REMIXED trial in chronic spontaneous urticaria (CSU).

"The Rhapsido presentations at EAACI 2026 expand our understanding of BTK inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options," said Angelika Jahreis, Global Head, Immunology Development, Novartis. "Novartis will present Rhapsido data from a long-term extension trial in chronic spontaneous urticaria, Phase III data in three types of chronic inducible urticaria, and early Phase II dose-response analysis for food allergy -- together providing scientific evidence for its impact across numerous diseases."

Abstracts accepted by EAACI include:

Molecule/Disease Abstract Title Abstract Number/Presentation Details

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

Rhapsido(R) (remibrutinib)

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

Chronic Remibrutinib demonstrated superior efficacy vs placebo Abstract #L-OAS03

Spontaneous and favorable safety in patients with chronic inducible Oral Presentation

Urticaria/Chronic urticaria in the phase 3 REMIND study June 12, 12:36 -- 12:48pm TRT

Inducible

Urticaria

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

Remibrutinib demonstrated continuous efficacy and Abstract #L-OAS03

favorable safety in patients with chronic spontaneous Oral Presentation

urticaria in the randomized withdrawal period of the June 12, 12:48 -- 1:00pm TRT

phase 3b REMIXED extension study

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

Remibrutinib-induced decreases in B cell biomarkers Abstract #FT27 (001230)

are associated with complete and sustained response Flash Talk

in chronic spontaneous urticaria patients June 15, 1:12pm -- 1:19pm TRT

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

Chronic REASSERT: A global, prospective, non-interventional, Abstract #FT23 (000333)

Spontaneous patient-centric study evaluating the effectiveness Flash Talk

Urticaria and safety of remibrutinib and quality of life (QoL) June 14, 6:03pm -- 6:10pm TRT

in patients with chronic spontaneous urticaria (CSU)

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

Food Allergy Efficacy and safety of remibrutinib in adults with Abstract #TPS44 - Food allergy 03 (001345)

IgE-mediated peanut allergy: A Phase 2 study Thematic Poster Session

June 13, 12:00pm -- 1:00pm TRT

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

Dose-response analysis of remibrutinib in oral food Abstract #TPS44 - Food allergy 03 (000736)

challenge outcomes among adults with IgE-mediated Thematic Poster Session

peanut allergy June 13, 12:00pm -- 1:00pm TRT

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

Disease focus

research

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

Chronic Urticaria Voices: Physician-reported perspectives Abstract #TPS23 - Biologicals 01 (000709)

Spontaneous of chronic urticaria care and its treatment in China Thematic Poster Session

Urticaria/Chronic (UV in China) June 12, 12:00pm -- 1:00pm TRT

Inducible

Urticaria

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

Chronic Urticaria Voices: Patient-reported disease burden Abstract #TPS42 - Dermatology 03 (000730)

Spontaneous and treatment experiences in Chronic Spontaneous Urticaria Thematic Poster Session

Urticaria in China - A real-world evidence study (UV in China) June 13, 12:00pm -- 1:00pm TRT

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

Unmet needs in treatment escalation for chronic spontaneous Abstract #FT23 (000769)

urticaria: Findings from the CURE Registry Flash Talk

June 14, 6:24pm -- 6:30pm TRT

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

Implementation of a urticaria care package in the Abstract #FT17 (000625)

general practitioner setting increased quality of Flash Talk

chronic spontaneous urticaria management June 14, 12:36pm -- 12:43pm TRT

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

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 significantly 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.

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