Novartis halts phase 3 remibrutinib study after efficacy goals prove unlikely
Key Facts
Novartis halted a phase 3 study of remibrutinib in patients with generalized myasthenia gravis after a feasibility analysis showed the treatment was unlikely to meet its efficacy goals. The company announced the decision in its third-quarter results update on October 27, 2026. The move ends a clinical program testing the drug for this disease, without affecting studies for other uses. Novartis said the analysis found no safety concerns. It added that stopping the study would not affect the remibrutinib program for other indications.
The study was designed as a randomized, double-blind trial comparing remibrutinib with placebo. It was planned to enroll 274 participants across 8 countries and 37 sites, according to the European Clinical Trials Register. The design aimed to measure the change in the total score on the Myasthenia Gravis Activities of Daily Living scale, known as MG-ADL. The primary assessment was scheduled after 6 months of treatment, on day 180. The trial therefore focused on the treatment's effect on patients' daily activities before the company ended the study following the feasibility analysis.
The decision comes days after Novartis announced positive results for remibrutinib in the phase 3 REMODEL-1 and REMODEL-2 trials for relapsing multiple sclerosis. The company said on October 23, 2026, that the drug reduced relapses compared with teriflunomide. The results put the drug on two divergent clinical paths: a setback in the myasthenia gravis study, alongside positive findings in the multiple sclerosis trials. In the third quarter, Novartis sales rose 4% to $14.522 billion compared with the same period in 2025. Core operating income also increased 10% at constant currencies to $6.036 billion.
The company continues to develop remibrutinib for other uses, including food allergy, chronic spontaneous urticaria in children, chronic spontaneous pruritus and hidradenitis suppurativa. The company report classifies food allergy as phase 3, with a filing planned in 2029 or later. It also lists 2027 as the planned first filing for chronic spontaneous urticaria in children and hidradenitis suppurativa. A filing for chronic spontaneous pruritus is also planned in 2029 or later. Novartis says stopping the myasthenia gravis study does not change these studies.
Remibrutinib received U.S. Food and Drug Administration approval to treat adults with chronic spontaneous urticaria on September 30, 2025. The approval was based on two trials involving 912 patients at 237 sites across 18 countries. On October 7, 2026, Novartis announced another U.S. approval for the drug to treat adults with symptomatic dermographism. These approvals add commercial context to its continued development beyond the myasthenia gravis study. At the company level, Novartis raised its 2026 core operating income outlook to stable or low single-digit growth, from a previous forecast of a low single-digit decline, and maintained its sales growth outlook at low single-digit growth.
Chief Executive Vas Narasimhan said growth in priority brands and launches, along with productivity efforts, supported the company's performance and enabled it to revise its full-year outlook. He added: "This, together with our productivity efforts, contributed to strong earnings performance and enabled us to raise our full-year guidance." The raised outlook reflects the distinction between the company's financial performance and the result of an individual study, while the decision to halt phase 3 is limited to remibrutinib's use for generalized myasthenia gravis. The drug's other studies remain ongoing, according to Novartis, with planned filing timelines in 2027 and 2029 or later.