Novartis announced positive Phase III trial results for ianalumab on August 11, 2025, marking a significant breakthrough in the treatment of Sjögren's disease, a chronic autoimmune disorder with substantial unmet medical needs. The novel monoclonal antibody successfully met its primary endpoints in trials for both Sjögren's disease and primary immune thrombocytopenia (ITP), positioning it as a potential first targeted treatment for Sjögren's disease.
Phase III Trial Results Demonstrate Efficacy and Safety
The results from the Phase III NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) trials demonstrated that ianalumab significantly reduces disease activity and shows a favorable safety profile in adults with active Sjögren's disease. This represents a major advancement for patients suffering from this chronic autoimmune disorder, which affects approximately 300,000 people in the United States alone.
The successful trial outcomes address a critical gap in treatment options for Sjögren's disease patients, who have historically faced limited therapeutic alternatives. The drug's ability to meet primary endpoints in both Sjögren's disease and primary immune thrombocytopenia suggests broad therapeutic potential across autoimmune conditions.
Leqvio Receives Expanded FDA Approval
In parallel developments, the FDA approved an updated label for Leqvio on July 31, 2025, enabling the cholesterol-lowering medication to be used as a twice-yearly monotherapy for low-density lipoprotein cholesterol (LDL-C) management in adults with hypercholesterolemia. This update no longer requires Leqvio to be used in combination with statins, potentially expanding its utility and simplifying treatment regimens for patients with high cholesterol levels.
The label expansion addresses patient adherence challenges in cholesterol management, a key risk factor for heart disease, by offering a more convenient dosing schedule and eliminating the need for combination therapy.
Strong Market Response and Institutional Interest
Following these positive developments, Novartis received Buy ratings from Kepler Capital and Deutsche Bank, while UBS maintained a Hold rating. The pharmaceutical giant continues to attract significant institutional interest, with 34 hedge funds currently holding stakes in the company.
The company's strong dividend profile, with an annual dividend of $3.99 per share, provides additional appeal to institutional investors seeking steady returns alongside growth potential from its expanding pipeline of innovative treatments.
