Novartis' Ianalumab Wins Breakthrough Therapy Tag for Sjogren's Disease

Novartis NVS announced that the FDA granted Breakthrough Therapy designation to its pipeline candidate, ianalumab for the treatment of adult patients with Sjogren’s disease — a chronic, systemic autoimmune disorder.

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 therapy for patients with Sjogren’s disease, if approved.

Over the past year, NVS shares have rallied 48% compared with the industry’s 24.1% rise.

Ianalumab was added to Novartis’ pipeline following collaboration with MorphoSys AG, which was acquired by the company in 2024.

The FDA also granted the Fast Track designation to ianalumab in 2016.

Sjogren’s disease is a progressive, heterogeneous, rheumatic, autoimmune disorder that causes inflammation and tissue damage across multiple organs, along with symptoms like dryness, fatigue, and pain, and can significantly reduce quality of life. The disease carries an increased risk of lymphoma. Currently, there are no approved disease-modifying therapies for this condition.

More on Novartis’ Ianalumab

Besides Sjogren’s disease, ianalumab is being studied in several other B-cell-driven autoimmune diseases, including immune thrombocytopenia (ITP), systemic lupus erythematosus, lupus nephritis, warm autoimmune hemolytic anemia, and diffuse cutaneous systemic sclerosis. The candidate showed promising efficacy and a favorable safety profile in systemic lupus erythematosus and immune thrombocytopenia studies.

In December 2025, Novartis announced positive results from the phase III VAYHIT2 study evaluating ianalumab plus eltrombopag in patients with ITP previously treated with corticosteroids.

Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, based on the primary endpoint of time to treatment failure, which assesses how long patients maintain safe platelet levels during and after the treatment period.

Notably, 62% of patients treated with ianalumab in combination with eltrombopag achieved sustained platelet response in six months compared with 39% with placebo plus eltrombopag.

Novartis plans to submit the VAYHIT2 data from second-line ITP, with results from the ongoing first-line ITP trial, VAYHIT1, to health authorities in 2027.

Novartis’ Zacks Rank & Stocks to Consider

NVS currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are MannKind MNKD, Keros Therapeutics KROS and Amicus Therapeutics FOLD, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for MannKind’s 2026 earnings per share have increased from 7 cents to 9 cents. MNKD shares have declined 13.3% over the past year.

MannKind’s earnings beat estimates in two quarters, missed in one and were in line in the remaining quarter, the average surprise being 33.33%.

Over the past 60 days, 2026 loss per share estimates for Keros Therapeutics have narrowed from $3.56 to $3.36. KROS shares have surged 73.6% over the past year.

Keros Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, the average surprise being 9098.63%.

Over the past 60 days, estimates for Amicus Therapeutics’ 2026 earnings per share have declined from 67 cents to 65 cents. FOLD shares have soared 52.2% over the past year.

Amicus Therapeutics’ earnings beat estimates in one quarter and missed in the remaining three trailing quarters, the negative average earnings surprise being 20.21%.

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