Novartis' Oral Remibrutinib Shows Positive Phase 3 Trial Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Source: Benzinga
- Trial Success: Novartis' pivotal Phase 3 RemIND trial for oral remibrutinib in chronic inducible urticaria (CIndU) met its primary endpoint, achieving significantly higher complete response rates compared to placebo, indicating the drug's potential in treatment.
- First Targeted Therapy: The data signifies remibrutinib's potential as the first targeted therapy for CIndU, with Global Head of Immunology Development Angelika Jahreis highlighting its positive trial results as a foundation for recent FDA approval in chronic spontaneous urticaria.
- Regulatory Progress: Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for remibrutinib's approval in symptomatic dermographism, enhancing its market position in urticaria treatment.
- Strong Stock Performance: Novartis shares rose 0.98% to $167.80 in premarket trading on Wednesday, reaching a new 52-week high, reflecting strong buying pressure, although the RSI of 83.54 suggests potential for a pullback.
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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: 165.380
Low
112.00
Averages
127.75
High
143.00
Current: 165.380
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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- Trial Success: Novartis' pivotal Phase 3 RemIND trial for oral remibrutinib in chronic inducible urticaria (CIndU) met its primary endpoint, achieving significantly higher complete response rates compared to placebo, indicating the drug's potential in treatment.
- First Targeted Therapy: The data signifies remibrutinib's potential as the first targeted therapy for CIndU, with Global Head of Immunology Development Angelika Jahreis highlighting its positive trial results as a foundation for recent FDA approval in chronic spontaneous urticaria.
- Regulatory Progress: Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for remibrutinib's approval in symptomatic dermographism, enhancing its market position in urticaria treatment.
- Strong Stock Performance: Novartis shares rose 0.98% to $167.80 in premarket trading on Wednesday, reaching a new 52-week high, reflecting strong buying pressure, although the RSI of 83.54 suggests potential for a pullback.
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- Complementary Expertise: This partnership leverages Unnatural Products' AI-enhanced macrocycle platform alongside Novartis' global expertise in drug development and commercialization, which is expected to accelerate the development of new therapies.
- Clinical Development Responsibility: Novartis will lead the clinical trials, production, and commercialization of the products, while Unnatural Products will receive up to $100 million in upfront and pre-IND milestone payments, ensuring liquidity during the project's early stages.
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- Trial Success: Novartis' pivotal Phase 3 RemIND trial for oral remibrutinib in chronic inducible urticaria (CIndU) met its primary endpoint, achieving significantly higher complete response rates compared to placebo, indicating the drug's potential in treatment.
- First Targeted Therapy: The data signifies remibrutinib's potential as the first targeted therapy for CIndU, with Global Head of Immunology Development Angelika Jahreis highlighting its positive trial results as a foundation for recent FDA approval in chronic spontaneous urticaria.
- Regulatory Progress: Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for remibrutinib's approval in symptomatic dermographism, enhancing its market position in urticaria treatment.
- Strong Stock Performance: Novartis shares rose 0.98% to $167.80 in premarket trading on Wednesday, reaching a new 52-week high, reflecting strong buying pressure, although the RSI of 83.54 suggests potential for a pullback.
See More
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- Poor Market Performance: As of February 13, 2026, Sprouts Farmers Market shares traded at $68.96, reflecting a 60.9% drop over the past year, significantly underperforming the S&P 500 by 73 percentage points, highlighting a decline in the company's competitive position.
- Portfolio Adjustment: The Sprouts Farmers Market position represented 1.02% of Promethos Capital's AUM, and following the liquidation, the fund's top five holdings shifted to include Taiwan Semiconductor and Novartis, indicating a strategic pivot towards other sectors.
- Future Growth Potential: Despite Promethos Capital's exit, Sprouts Farmers Market is actively expanding, aiming for 1,400 locations in the long term, with 70% of its products being attribute-driven, showcasing its differentiated competitive advantage in the health food market.
See More
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- Emerging Market Potential: Emerging market stocks are expected to return 12.8% annually, primarily supported by robust earnings growth in China and India, highlighting the significance and appeal of these markets in the global economy.
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- US vs. European Stocks: While US stocks outperformed European stocks over the past decade, Goldman believes that due to high valuations in the US market, European stocks may surpass them in the next decade, prompting investors to reassess their asset allocation strategies.
See More
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- Increased Investor Attention: With ongoing innovations and policy support in the health care industry, investor attention towards health care stocks has significantly increased, potentially attracting more capital into the sector and driving stock prices higher.
- Optimistic Industry Outlook: The growth potential and stability of the health care sector make it attractive amid economic uncertainties, leading investors to view it as a safe haven, further propelling the upward trend in health care stocks.
See More
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- Study Overview: Novartis's ALIGN study indicates that Vanrafia (atrasentan) slows the decline of kidney function in IgA nephropathy patients, with a clinically meaningful eGFR change of 2.39 ml/min/1.73m² compared to placebo, highlighting its potential in chronic kidney disease management.
- Accelerated Approval Context: Vanrafia received accelerated approval in April 2025 in the U.S. and China for reducing proteinuria in IgAN patients, with Novartis planning to submit for traditional approval in 2026 to further validate its clinical benefits.
- Long-Term Follow-Up Advantage: The ALIGN study provides the longest follow-up period in pivotal Phase 3 studies for IgAN, ensuring a thorough assessment of Vanrafia's long-term effects, with safety consistent with previous findings, bolstering confidence in its market prospects.
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See More
