Novartis AG announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on February 26 2026, a decision that was disclosed on February 27 2026, for its oral Bruton’s tyrosine kinase inhibitor remibrutinib in the treatment of chronic spontaneous urticaria (CSU).
The CHMP recommendation was based on data from the pivotal REMIX‑1 and REMIX‑2 Phase III trials, which demonstrated rapid and sustained improvement in itch, hives and quality‑of‑life measures, and a favorable safety profile for remibrutinib. The drug, also known as Rhapsido in the United States, received FDA approval for CSU in September 2025, underscoring its clinical promise.
A positive CHMP opinion is a critical regulatory milestone that paves the way for European Commission approval, which is expected within roughly two months. If approved, remibrutinib would become the first oral therapy for CSU patients who do not respond adequately to H1‑antihistamines, filling a substantial unmet need in the EU market.
Strategically, the approval strengthens Novartis’s immunology portfolio and positions the company to compete more directly with biologic therapies such as omalizumab and ligelizumab. The move aligns with Novartis’s broader shift toward immunology and underserved conditions, moving away from more common indications like psoriasis.
Financially, Novartis reported full‑year 2025 net sales of $54.5 billion, an 8% increase, and core operating income of $21.9 billion, up 14%, with a core operating margin of 40.1%. Q4 2025 net sales were $13.3 billion, a 1% decline in local currency, while core operating income rose 1%. The company’s 2026 guidance projects low single‑digit sales growth and a low single‑digit decline in core operating income, largely due to patent expiries and generic competition, especially for Entresto.
Segment analysis shows that 2025 growth drivers included priority brands such as Kisqali, Kesimpta, Pluvicto, Scemblix and Cosentyx, highlighting the strength of Novartis’s oncology and dermatology lines. The addition of remibrutinib would diversify revenue streams within the immunology segment.
Patrick Horber, President of International Novartis, said, “Today’s positive CHMP opinion is an important step towards addressing the significant unmet needs of adults living with CSU in Europe.” He added, “We will continue to collaborate with regulatory authorities globally to make this important medicine, discovered and developed by Novartis, available to patients who need it most.”
Remibrutinib is also under investigation for other immune‑mediated indications, including chronic inducible urticaria, food allergy and hidradenitis suppurativa, indicating Novartis’s intent to leverage the molecule across multiple therapeutic areas. The drug’s mechanism—BTK inhibition to block histamine release—offers a novel therapeutic approach distinct from existing biologics.
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