Novartis AG (NVS) Monday said that it will present data from five key abstracts evaluating Rhapsido, also known as Remibrutinib in chronic spontaneous urticaria or CSU and as an investigational therapy for peanut allergy, at the American Academy of Allergy, Asthma & Immunology or AAAAI Annual Meeting in Philadelphia, from February 27 to March 2, 2026.
Remibrutinib is a selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives ( and swelling.
Chronic spontaneous urticaria is the medical term for chronic hives or rash/wheals and/or deep tissue swelling that lasts for at least 6 weeks. CSU affects approximately 40 million people worldwide noted Novartis.
These presentations may provide more evidence on the use of Rhapsido in CSU, as well as its potential in other indications.
The presentation also includes analyses from the REMIX-1 & -2 studies on CSU disease control and early symptom relief.
REMIX-1 and REMIX-2 are two identically designed global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III studies, with REMIX-1 consisting of 470 participants and REMIX-2 consisting of 455 participants which demonstrated positive results evaluating Remibrutinib 25 mg in patients with CSU, whose symptoms are inadequately controlled by H1-antihistamine.
In addition, Phase II data evaluating safety and efficacy results of Remibrutinib for the treatment of peanut allergy will also be featured in an oral session.
Peanut allergy is one of the most common food allergies among children in Western nations and is often lifelong.
The phase 2, multi-centre, randomised, investigator- and participant-blinded, placebo-controlled study evaluated the safety, efficacy and tolerability of Remibrutinib or LOU064 in 3 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.
Notably, Remibrutinib's Phase III program in food allergy is planned for second half of 2026.
Last week, Novartis reported that oral Remibrutinib has achieved the primary endpoint in the Phase III RemIND trial of oral remibrutinib in three of the most prevalent types of chronic inducible urticaria or CIndU, with significantly higher complete response rates versus placebo at Week 12.
CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide. It is a form of chronic urticaria characterized by hives and/or swelling, with identifiable external triggers, like pressure, sunlight, friction, heat, cold or water.
Novartis has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of CIndU.
In the US and China, Remibrutinib is approved for the treatment of adult patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamines, under the brand name Rhapsido.
NVS has traded between $97.72 and $167.29 in the last one year. The stock closed Friday's trade at $162.67, down at 0.76%.
In the pre-market, NVS shares are up 0.48% to $163.46.
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