Novartis' Ianalumab Wins Breakthrough Therapy Tag for Sjogren's Disease [Yahoo! Finance]
Novartis AG (NVS)
Last novartis ag earnings: 4/28 01:00 am
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Source: Yahoo! Finance
Ianalumab is an investigational monoclonal antibody with a novel dual mechanism of action, designed to deplete B-cells by targeting the BAFF receptor while inhibiting B-cell activation and survival. The Breakthrough Therapy designation for ianalumab is supported by data from the phase III NEPTUNUS-1 and NEPTUNUS-2 studies. These global, multicenter, pivotal studies achieved their primary endpoints by demonstrating clinically meaningful and statistically significant improvements in disease activity as measured by a reduction in ESSDAI compared with placebo. The ESSDAI score is a popular clinical tool used to measure systemic disease activity in patients with primary Sjogren's syndrome. Ianalumab was well-tolerated and showed a favorable safety profile despite certain side effects. Novartis intends to submit regulatory applications to several global health authorities (including the FDA) to commercialize ianalumab beginning in early 2026. Ianalumab would become the first targeted
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NVS
Earnings
- 10/28/25 - Miss
NVS
Sec Filings
- 1/16/26 - Form S-8
- 1/16/26 - Form S-8
- 1/16/26 - Form S-8
- NVS's page on the SEC website