Novartis' Fabhalta Significantly Improves Kidney Function in IgAN Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy NVS?
Novartis announced final two-year results from the Phase III APPLAUSE-IgAN study of Fabhalta in IgA nephropathy, IgAN. Fabhalta demonstrated a statistically significant, clinically meaningful improvement in estimated glomerular filtration rate slope, a key marker of kidney function, compared with placebo. Fabhalta consistently outperformed placebo across key kidney outcomes over two years, demonstrating a slowing of disease progression and the potential to preserve kidney function in IgAN1. The results were published in the New England Journal of Medicine and simultaneously presented as late-breaking data at the 2026 World Congress of Nephrology, WCN. "Persistent kidney inflammation is a hallmark of IgAN, and a key driver of disease progression, leading to ongoing kidney damage and loss of function over time," said Vlado Perkovic, MD, Professor of Medicine and Provost, University of New South Wales, and Steering Committee Co-Chair of the APPLAUSE-IgAN study. "These results are important because they show that Fabhalta can reduce the risk of disease progression, help preserve kidney health, and address outcomes associated with long-term disease burden."
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Analyst Views on NVS
Wall Street analysts forecast NVS stock price to fall
6 Analyst Rating
1 Buy
4 Hold
1 Sell
Hold
Current: 150.360
Low
112.00
Averages
127.75
High
143.00
Current: 150.360
Low
112.00
Averages
127.75
High
143.00
About NVS
Novartis AG is a Switzerland-based pharmaceutical company. The Company develops, manufactures, and markets branded and generic prescription drugs, active pharmaceutical ingredients (APIs), biosimilars and ophthalmic products. The Company uses science and digital technologies for treatments in the disease areas of immunology, dermatology, cancer, ophthalmology, neuroscience, respiratory, cardiovascular, renal and metabolism. The business activities of the Company are divided into two segments: Innovative Medicines, which includes innovative patent-protected prescription medicines for blood pressure, cancer and other ailments, and Sandoz, which includes generic pharmaceuticals and biosimilars.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Results: In the APPLAUSE-IgAN study, Fabhalta significantly reduced the risk of kidney failure, with patients experiencing a 49.3% slower decline in kidney function compared to placebo, indicating its critical role in delaying disease progression in IgAN patients.
- Proteinuria Improvement: Over two years, 40.7% of patients on Fabhalta achieved the target of less than 1g/g proteinuria in 24-hour urine collections, significantly outperforming the 23.7% in the placebo group, highlighting Fabhalta's potential in enhancing kidney health.
- FDA Priority Review: Fabhalta has received priority review from the FDA based on its novel mechanism of action and robust data, which is expected to provide more effective treatment options for IgAN patients and further solidify Novartis's leadership in the kidney disease sector.
- Safety Assessment: The safety profile of Fabhalta over two years was consistent with previous findings, with low rates of adverse events comparable to placebo, establishing a solid foundation for its long-term use and enhancing patient confidence in the treatment.
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- Clinical Trial Results: In the APPLAUSE-IgAN study, Fabhalta significantly reduced the risk of kidney failure, with patients experiencing a 49.3% slower decline in kidney function compared to placebo, indicating its critical role in delaying disease progression in IgAN patients.
- Proteinuria Improvement: Over two years, 40.7% of patients on Fabhalta achieved the target of less than 1g/g proteinuria in 24-hour urine collections, significantly outperforming the 23.7% in the placebo group, highlighting Fabhalta's potential in enhancing kidney health.
- FDA Priority Review: Fabhalta has received priority review from the FDA based on its novel mechanism of action and robust data, which is expected to provide more effective treatment options for IgAN patients and further solidify Novartis's leadership in the kidney disease sector.
- Safety Assessment: The safety profile of Fabhalta over two years was consistent with previous findings, with low rates of adverse events comparable to placebo, establishing a solid foundation for its long-term use and enhancing patient confidence in the treatment.
See More
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Industry Response: The healthcare sector is currently working to adopt AI technologies, highlighting a broader trend towards innovation in medical practices.
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- Acquisition Scale: Novartis has announced a proposed acquisition of Excellergy for up to $2 billion, including upfront and milestone payments, expected to close in the second half of 2026, demonstrating the company's strategic commitment to expanding its immunology pipeline.
- Therapeutic Potential: Exl-111, a next-generation anti-IgE antibody currently in phase I trials, could significantly broaden Novartis' market reach across high-value indications such as food allergies and chronic urticaria if clinical data validate early findings.
- Enhanced Allergy Portfolio: This acquisition complements Novartis' existing allergy product line, particularly the co-promoted Xolair with Roche, further solidifying its deep expertise in IgE biology and supporting long-term growth in the immunology sector.
- Market Performance and Outlook: Novartis shares have risen 33% over the past year, significantly outperforming the industry growth of 10.1%, and despite facing generic competition for key drugs, the company is banking on key growth drivers like Kisqali and Kesimpta to support revenue growth.
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- Acquisition Scale: Novartis has agreed to acquire Excellergy for up to $2 billion in upfront and milestone payments, with the transaction expected to close in the second half of 2026, marking a significant investment in its immunology strategy.
- New Therapy Development: Excellergy's Exl-111, a Phase 1 anti-IgE antibody, aims to surpass conventional therapies by dissociating receptor-bound IgE, potentially offering faster and deeper suppression of allergic pathways, which could improve symptom control for food allergies, chronic urticaria, and allergic asthma.
- Support from Preclinical Data: Fiona Marshall, President of Biomedical Research at Novartis, highlighted that Exl-111 has shown promising results in preclinical and early clinical data, supporting its potential for stronger disease control and more convenient dosing, thereby enhancing Novartis's treatment options in allergic diseases.
- Market Performance: Novartis's stock has traded between $97.72 and $170.46 over the past year, closing at $149.70 on Thursday with a 0.70% increase, although it dipped slightly to $149.38 in pre-market trading, reflecting a positive market reaction to the acquisition news.
See More
Novartis Acquires Excellergy for Up to $2B to Enhance Allergy Portfolio
- Acquisition Scale: Novartis announced its acquisition of U.S. biotech firm Excellergy for up to $2 billion in upfront and milestone payments, aiming to strengthen its allergy portfolio, with the deal expected to close in the second half of the year.
- New Drug Candidate: This acquisition will add Excellergy's drug candidate Exl-111 to Novartis' portfolio, which is currently in early-stage clinical trials and designed to treat specific allergic disorders.
- Mechanism Advantages: Exl-111 is a trifunctional Effector Cell Response Inhibitor, and if clinically confirmed, its mechanism could support earlier symptom relief, stronger disease control, more convenient dosing, and broader applications across food allergies, allergic asthma, and other IgE-driven diseases.
- Strategic Collaboration Outlook: Fiona Marshall, President of Biomedical Research at Novartis, stated that Excellergy's differentiated next-generation anti-IgE program complements Novartis' biological expertise, and together they will be ideally positioned to realize the full potential of Exl-111 and the broader ECRI pipeline for millions of patients suffering from severe allergic diseases.
See More
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- Acquisition Scale: Novartis has announced its acquisition of California-based biotech company Excellergy for up to $2 billion, marking its second significant acquisition in recent weeks and demonstrating its commitment to expansion in the biopharmaceutical sector.
- Market Impact: This acquisition will strengthen Novartis' position in the immunology market for food allergies, as Excellergy's drug candidate Exl-111 is expected to provide earlier relief from allergy symptoms, addressing the urgent demand for new therapies in this area.
- Future Outlook: The transaction is expected to close in the second half of 2026, subject to customary conditions including regulatory approvals, further solidifying Novartis' competitive advantage in the biopharmaceutical industry through strategic positioning.
- Ongoing Investment Plans: Last year, Novartis announced a $23 billion investment plan to build and expand its facilities in the U.S. over the next five years, with construction already underway in four states including California, reflecting its focus on the U.S. market and long-term growth strategy.
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