Novartis (NVS) Receives FDA Breakthrough Therapy Designation for Ianalumab, Global Submissions to Start in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 16 2026
0mins
Should l Buy NVS?
Source: seekingalpha
- FDA Breakthrough Designation: Novartis' ianalumab has received Breakthrough Therapy designation from the FDA, aimed at expediting the development of treatments for the serious autoimmune condition Sjögren’s disease, marking a significant advancement for the company in this area.
- Global Submission Plans: The company plans to initiate global regulatory submissions for ianalumab in early 2026, and if approved, it could become the first targeted treatment for this patient group, potentially transforming the treatment landscape for Sjögren’s disease.
- Clinical Trial Results: Ianalumab has demonstrated efficacy in the NEPTUNUS-1 and NEPTUNUS-2 Phase 3 trials, further supporting its potential as a treatment for Sjögren’s disease, which affects approximately 0.25% of the population and addresses an urgent medical need.
- Regulatory Support Benefits: The FDA's Breakthrough Therapy designation provides Novartis with extensive regulatory guidance and potential eligibility for priority review, thereby accelerating the approval process and enhancing the company's competitive position in the biopharmaceutical sector.
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Analyst Views on NVS
Wall Street analysts forecast NVS stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for NVS is 127.75 USD with a low forecast of 112.00 USD and a high forecast of 143.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
1 Buy
4 Hold
1 Sell
Hold
Current: 153.950
Low
112.00
Averages
127.75
High
143.00
Current: 153.950
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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- Alphabet's Strong Performance: Alphabet exceeded Wall Street expectations in its fourth-quarter earnings report released on Wednesday, although its stock fell about 1% in after-hours trading; the projected capital expenditures for 2026 are expected to reach between $175 billion and $185 billion, nearly double that of 2025, reflecting a strong commitment to future growth.
- Qualcomm's Disappointing Guidance: Qualcomm reported quarterly earnings that surpassed expectations, yet its stock fell 9% in after-hours trading due to disappointing forward guidance, highlighting investor concerns about future performance, with shares down nearly 13% year-to-date in 2026.
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- Sales Growth Challenges: Novartis reported a 1% year-over-year increase in net sales to $13.34 billion for Q4 2025, falling short of Wall Street's $13.78 billion estimate, indicating challenges in achieving sales growth amid fierce competition.
- Core Operating Income Slightly Up: Core operating income rose 1% to $4.93 billion, benefiting from increased government grant income and reduced SG&A expenses, although higher R&D costs partially offset these gains, resulting in a core operating income margin of 37.0%.
- Strong Performance from Blockbusters: Demand for blockbuster therapies like Kisqali and Kesimpta surged by 44% and 27% respectively, driving overall performance and demonstrating Novartis's competitive strength in oncology and multiple sclerosis markets.
- Cautiously Optimistic Outlook: Novartis expects low single-digit growth in net sales for 2026, while core operating income may decline slightly; however, the incoming CFO indicated that operating income is set to grow significantly in the second half of the year, suggesting strong potential for future growth.
See More
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- Earnings Highlights: Novartis reported a Q4 non-GAAP EPS of $2.03, beating expectations by $0.03, indicating stable profitability; however, total revenue of $13.34 billion grew only 1.4% year-over-year, missing market expectations, reflecting the impact of generic erosion in the U.S. market.
- Sales and Revenue: Net sales decreased by 1% year-over-year, with a 1% increase in USD terms when excluding currency effects, suggesting that while the company maintains some revenue levels amid market challenges, core operating income growth of only 1% indicates pressure on profitability.
- Cash Flow Situation: Free cash flow amounted to $1.7 billion, down 54% year-over-year, primarily driven by lower cash flows from operating activities, which may impact the company's reinvestment capabilities and shareholder return strategies.
- Future Outlook: Novartis expects low single-digit growth in net sales and a slight decline in core operating income for 2026; despite facing the largest patent expiry in its history, the company remains optimistic about its mid-term guidance, emphasizing the resilience and ongoing growth potential of its business.
See More
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- Shareholder Voting: The dividend proposal will be voted on at the Annual General Meeting scheduled for March 6, 2026, reflecting the importance of corporate governance transparency and shareholder engagement in decision-making processes.
- Market Reaction: Despite the dividend increase, Novartis faces a rating downgrade, leading to cautious market expectations regarding future growth, which may impact investor confidence and stock performance.
- Outlook Challenges: Novartis anticipates a transition year in 2026, with a soft outlook for FY26, highlighting the challenges the company faces in strategic adjustments and market adaptation.
See More
