NVS Reports Positive Late-Stage Data on Kidney Disease Drug

Novartis NVS recently announced positive final results from the late-stage, APPLAUSE-IgAN, study on Fabhalta (iptacopan) in adults living with IgA nephropathy (IgAN), a progressive autoimmune kidney disease.

Fabhalta, an oral, Factor B inhibitor of the alternative complement pathway, received accelerated approval in the United States in August 2024 for the reduction of proteinuria in adults with IgAN at risk of rapid disease progression.

APPLAUSE-IgAN is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral Fabhalta in 477 primary IgAN patients (main study population).

In the final analysis of APPLAUSE-IgAN, Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate decline over two years.  

The positive data from this study will support the company’s regulatory submission for traditional FDA approval of the drug in 2026.

More on NVS’ Fabhalta

Fabhalta obtained FDA and European Commission (EC) approval in December 2023 and May 2024, respectively, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

The drug is also approved in China for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression.

Earlier in 2025, Fabhalta received FDA and EC approval for the treatment of adults with C3 glomerulopathy (C3G). The drug is also approved in China and Japan for C3G.

Fabhalta is also being evaluated in a variety of rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN).

Novartis’ IgAN portfolio also includes Vanrafia (atrasentan) and investigational candidtae zigakibart.

We note that Travere Therapeutics’ TVTX Filspari (sparsentan) is also approved to slow kidney function decline in adults with primary IgAN who are at risk of disease progression.

The drug was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. In September 2024, TVTX received full approval of Filspari for the above-mentioned indication based on positive long-term confirmatory results from the PROTECT study demonstrating that Filspari significantly slowed kidney function decline over two years compared to irbesartan.

NVS Looks to Broaden Portfolio

Novartis’ performance has been strong in the past few quarters, driven by the solid performance of its key brands.

Approval of new drugs and label expansion of existing drugs should enable the company to offset the adverse impacts of generic competition for Tasigna and Promacta.

NVS recently obtained FDA approval for Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Shares of Novartis have gained 36.7% year to date compared with the industry’s growth of 7.5%.

While organic growth continues to drive business, NVS is focused on strategic acquisitions and deals to strengthen its pipeline.

NVS is all set to acquire Tourmaline Bio, Inc. TRML, a New York-based, publicly traded clinical-stage biopharmaceutical company, for $1.4 billion.

The acquisition will add phase III ready candidate pacibekitug to NVS’ cardiovascular pipeline.

TRML is developing pacibekitug, an anti-IL-6 monoclonal antibody, as a treatment option for atherosclerotic cardiovascular disease.

In June 2025, Novartis acquired Regulus Therapeutics Inc., a clinical-stage biopharmaceutical company.

NVS’ Zacks Rank and Stock to Consider

Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked large-cap pharma stock is Bayer BAYRY, which has a Zacks Rank #1 (Strong Buy) at present.  You can see the complete list of today’s Zacks #1 Rank stocks here.

BAYRY’s earnings per share estimate has increased from $1.32 to $1.37 for 2025 over the past 90 days and the same for 2026 has risen from $1.36 to $1.44. Year to date, shares of Bayer have surged 62.2%.

 

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