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NVS Reports Positive Late-Stage Data on Kidney Disease Drug Vanrafia
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Key Takeaways
Novartis reported positive phase III ALIGN results for Vanrafia in IgA nephropathy.
Vanrafia slowed eGFR decline vs placebo, with benefits seen through week 136.
Novartis plans to seek traditional approval in 2026 after U.S. and China accelerated nods.
Novartis (NVS - Free Report) announced positive results from the late-stage III ALIGN study on kidney disease drug Vanrafia (atrasentan).
The ALIGN study is a global, randomized, multicenter, double-blind, placebo-controlled trial evaluating the efficacy and safety of Vanrafia versus placebo in patients with IgA nephropathy at risk of progressive kidney function decline.
The results favored Vanrafia across multiple timepoints, key kidney function measures, and in patients receiving background SGLT2 inhibitor therapy.
More on NVS’ ALIGN Study Results
Vanrafia is a potent, highly selective endothelin A (ETA) receptor antagonist targeting the endothelin system, a key driver in the progression of IgAN.
Results from the ALIGN study showed a slowing of kidney function decline in adults with IgAN treated with Vanrafia. At week 136, four weeks after treatment ended, Vanrafia demonstrated a 2.39 ml/min/1.73m² difference in estimated glomerular filtration rate (eGFR) change from baseline versus placebo.
Clinically meaningful benefits were also seen with Vanrafia compared to placebo in eGFR change from baseline at the end of treatment at week 132, with a 2.59 ml/min/1.73m² difference in eGFR change from baseline compared with placebo.
Similar results were observed in a prespecified exploratory subgroup of patients receiving SGLT2 inhibitors.
ALIGN offers the longest follow-up period among pivotal phase III IgAN studies. The safety profile was consistent with previous findings.
We note that Vanrafia received accelerated approval in the United States and China in 2025 for reducing proteinuria in adults with IgA nephropathy, and Novartis plans to seek traditional approval in 2026.
Apart from Vanrafia, NVS’ renal portfolio includes Fabhalta (iptacopan) and pipeline candidate zigakibart.
Fabhalta is an oral, Factor B inhibitor of the alternative complement pathway.
Fabhalta is approved in the United States and the EU for treating adults with paroxysmal nocturnal hemoglobinuria. The therapy also received accelerated approval in the United States (August 2024) and China (September 2025) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. In 2025, Fabhalta further gained approvals in the United States, European Union, China and Japan for the treatment of adults with C3 glomerulopathy, becoming the first approved therapy for this condition.
Fabhalta clocked in sales of $155 million in the fourth quarter and $505 million in 2025.
NVS Navigates Generic Competition for Entresto
2026 is a pivotal year for Novartis as it navigates the largest patent expiry (for cardiovascular drug Entresto) in its history.
Shares of Novartis have gained 52.9% over the past year compared with the industry’s growth of 20.6%.
Image Source: Zacks Investment Research
Last week, NVS reported mixed results for the fourth quarter of 2025, with earnings beating estimates but revenues missing the same.
Sales are being adversely impacted by generic competition for key drugs Entresto (United States) and Promacta.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto and Scemblix — to support top-line growth.
Pipeline progress remains a major upside, with multiple potential multi-blockbusters advancing through FDA approvals and positive phase III data across Rhapsido, Pluvicto, Itvisma and ianalumab.
NVS’ Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #4 (Sell).
Over the past 60 days, estimates for Exelixis’ 2026 earnings per share (EPS) have risen from $3.18 to $3.45. EXEL shares have surged 11% over the past six months.
Exelixis’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 24.95%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 17.8% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 4.58%.
Shares of Bayer have skyrocketed 138.9% in the past year. Estimates for BAYRY’s 2026 earnings per share have increased from $1.43 to $1.51 over the past 60 days.
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NVS Reports Positive Late-Stage Data on Kidney Disease Drug Vanrafia
Key Takeaways
Novartis (NVS - Free Report) announced positive results from the late-stage III ALIGN study on kidney disease drug Vanrafia (atrasentan).
The ALIGN study is a global, randomized, multicenter, double-blind, placebo-controlled trial evaluating the efficacy and safety of Vanrafia versus placebo in patients with IgA nephropathy at risk of progressive kidney function decline.
The results favored Vanrafia across multiple timepoints, key kidney function measures, and in patients receiving background SGLT2 inhibitor therapy.
More on NVS’ ALIGN Study Results
Vanrafia is a potent, highly selective endothelin A (ETA) receptor antagonist targeting the endothelin system, a key driver in the progression of IgAN.
Results from the ALIGN study showed a slowing of kidney function decline in adults with IgAN treated with Vanrafia. At week 136, four weeks after treatment ended, Vanrafia demonstrated a 2.39 ml/min/1.73m² difference in estimated glomerular filtration rate (eGFR) change from baseline versus placebo.
Clinically meaningful benefits were also seen with Vanrafia compared to placebo in eGFR change from baseline at the end of treatment at week 132, with a 2.59 ml/min/1.73m² difference in eGFR change from baseline compared with placebo.
Similar results were observed in a prespecified exploratory subgroup of patients receiving SGLT2 inhibitors.
ALIGN offers the longest follow-up period among pivotal phase III IgAN studies. The safety profile was consistent with previous findings.
We note that Vanrafia received accelerated approval in the United States and China in 2025 for reducing proteinuria in adults with IgA nephropathy, and Novartis plans to seek traditional approval in 2026.
Apart from Vanrafia, NVS’ renal portfolio includes Fabhalta (iptacopan) and pipeline candidate zigakibart.
Fabhalta is an oral, Factor B inhibitor of the alternative complement pathway.
Fabhalta is approved in the United States and the EU for treating adults with paroxysmal nocturnal hemoglobinuria. The therapy also received accelerated approval in the United States (August 2024) and China (September 2025) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. In 2025, Fabhalta further gained approvals in the United States, European Union, China and Japan for the treatment of adults with C3 glomerulopathy, becoming the first approved therapy for this condition.
Fabhalta clocked in sales of $155 million in the fourth quarter and $505 million in 2025.
NVS Navigates Generic Competition for Entresto
2026 is a pivotal year for Novartis as it navigates the largest patent expiry (for cardiovascular drug Entresto) in its history.
Shares of Novartis have gained 52.9% over the past year compared with the industry’s growth of 20.6%.
Image Source: Zacks Investment Research
Last week, NVS reported mixed results for the fourth quarter of 2025, with earnings beating estimates but revenues missing the same.
Sales are being adversely impacted by generic competition for key drugs Entresto (United States) and Promacta.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto and Scemblix — to support top-line growth.
Pipeline progress remains a major upside, with multiple potential multi-blockbusters advancing through FDA approvals and positive phase III data across Rhapsido, Pluvicto, Itvisma and ianalumab.
NVS’ Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the pharma/biotech sector are Exelixis (EXEL - Free Report) , Alkermes (ALKS - Free Report) and Bayer (BAYRY - Free Report) . While EXEL and ALKS sport a Zacks Rank #1 (Strong Buy) each, BAYRY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Exelixis’ 2026 earnings per share (EPS) have risen from $3.18 to $3.45. EXEL shares have surged 11% over the past six months.
Exelixis’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 24.95%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 17.8% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 4.58%.
Shares of Bayer have skyrocketed 138.9% in the past year. Estimates for BAYRY’s 2026 earnings per share have increased from $1.43 to $1.51 over the past 60 days.