Novartis Unveils Phase III CSU Data and Phase II Peanut Allergy Results
Novartis will present new Phase III REMIX-1 and REMIX-2 data showing early symptom relief and improved disease control with its oral BTKi remibrutinib in chronic spontaneous urticaria at the AAAAI Annual Meeting Feb 27–Mar 2, 2026. The company will also unveil Phase II peanut allergy results and plans a Phase III peanut allergy program in 2026, while regulatory reviews for CSU are underway in the EU and Japan.
1. Presentation Overview
Novartis will showcase five key abstracts on remibrutinib at the AAAAI Annual Meeting in Philadelphia from February 27 to March 2, 2026. The oral Bruton's tyrosine kinase inhibitor Rhapsido® has already gained FDA approval for chronic spontaneous urticaria and is now being studied for broader immune indications.
2. CSU Trial Findings
Phase III REMIX-1 and REMIX-2 data will highlight remibrutinib’s impact on early symptom relief and sustained disease control in chronic spontaneous urticaria. These analyses follow the recent FDA nod and aim to support label expansions and market uptake.
3. Peanut Allergy Expansion
For the first time, Novartis will present Phase II data on remibrutinib’s efficacy in IgE-mediated peanut allergy during an oral session. Positive findings have prompted plans for a Phase III peanut allergy program slated to begin in 2026, targeting a large unmet therapeutic need.
4. Regulatory Filings and Future Plans
Global regulatory reviews for remibrutinib in CSU are in progress in the European Union and Japan. The company completed an FDA submission in Q4 2025 for symptomatic dermographism and reported positive topline results in two additional CIndU arms, while full data will be filed with authorities in coming months.