NVO Receives FDA Approval for MASH Therapy: ETFs Expected to Benefit
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 19 2025
0mins
Should l Buy NVO?
Source: NASDAQ.COM
Wegovy Approval: Novo Nordisk's obesity drug, Wegovy, received accelerated FDA approval to treat metabolic dysfunction-associated steatohepatitis (MASH), marking it as the first GLP-1 class treatment for this liver condition.
Efficacy Results: The approval is based on the ESSENCE trial results, showing that 62.9% of participants on Wegovy achieved resolution of steatohepatitis without worsening fibrosis, compared to 34.3% on placebo.
Market Impact: Following the announcement, Novo Nordisk's shares rose nearly 4%, and Wegovy is expected to significantly contribute to the company's revenue from MASH treatments.
ETF Exposure: Several exchange-traded funds (ETFs) have substantial holdings in Novo Nordisk, including Roundhill GLP-1 & Weight Loss ETF, Amplify Weight Loss Drug & Treatment ETF, and VanEck Pharmaceutical ETF.
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Analyst Views on NVO
Wall Street analysts forecast NVO stock price to rise
8 Analyst Rating
4 Buy
3 Hold
1 Sell
Moderate Buy
Current: 48.740
Low
42.00
Averages
54.67
High
70.00
Current: 48.740
Low
42.00
Averages
54.67
High
70.00
About NVO
Novo Nordisk A/S is a global healthcare company engaged in diabetes care. The Company is also engaged in the discovery, development, manufacturing and marketing of pharmaceutical products. The Company operates through two business segments: diabetes and obesity care, and biopharmaceuticals. The Company's diabetes and obesity care segment covers insulin, GLP-1, other protein-related products, such as glucagon, protein-related delivery systems and needles, and oral anti-diabetic drugs. The Company's biopharmaceuticals segment covers the therapy areas of hemophilia care, growth hormone therapy and hormone replacement therapy. The Company also offers Saxenda product to treat obesity. It offers a range of products, including NovoLog/NovoRapid; NovoLog Mix/NovoMix; Prandin/NovoNorm; NovoSeven; Norditropin, and Vagifem. As of December 31, 2016, it marketed its products in over 180 countries. Its regional structure consists of two commercial units: North America and International Operations.
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.
Novo Nordisk to Increase Investment in Ireland for Wegovy Production
- Investment Expansion: Novo Nordisk plans to expand its manufacturing site in Athlone, Ireland, to produce its newly approved oral weight loss drug Wegovy, aiming to cater to markets outside the U.S., demonstrating the company's commitment to global market presence.
- Strong Market Performance: Since its U.S. launch in January, Wegovy has attracted over 45,000 patients, marking one of the most successful pharmaceutical rollouts in history, reflecting its significant potential in the weight loss market.
- Future Revenue Outlook: Despite projecting a 13% year-over-year decline in revenue for 2026 due to increased competition and patent expirations, the company's decision to invest in Ireland indicates confidence in future growth prospects.
- Regulatory Filing Progress: Novo Nordisk plans to submit regulatory filings for Wegovy in the EU and other regions in the second half of 2025, further expanding its market share and showcasing its proactive strategy in the face of competition.
See More
Novo Nordisk Launches Wegovy in Vials to Compete
- Intensifying Market Competition: Novo Nordisk plans to launch its Wegovy drug in vials to counteract pressure from rival Eli Lilly in the rapidly growing weight-loss market, especially after Lilly's introduction of vials for Zepbound in 2024 led to a surge in demand and shortages of its injector pens.
- Flexible Dosing Advantage: The new vial format will offer more flexible dosing compared to prefilled injector pens, although patients will need to manually draw the medication into a syringe, a change aimed at meeting the broader needs of obesity patients and aligning with Novo Nordisk's long-term strategic goals.
- Sales Outlook Downgrade: Novo Nordisk expects adjusted sales growth for 2026 to decline by 5% to 13%, primarily due to the impact of the U.S. “Most Favored Nations” agreement and the expiration of the semaglutide molecule patent in certain international markets, which will negatively affect the company's future revenue.
- Legal Action Update: Novo Nordisk recently filed a lawsuit against Hims & Hers, demonstrating the company's proactive stance in protecting its market share and intellectual property, even as its stock price fell by 0.82% to $48.34 at the time of publication, reflecting market concerns about its future performance.
See More
McDonald's CEO Faces Challenge from GLP-1 Weight-Loss Drugs
- Market Adaptation: McDonald's CEO Chris Kempczinski noted that while the adoption of GLP-1 drugs is increasing, it has not yet materially impacted the company's business, demonstrating resilience in the face of new competition.
- Product Strategy Adjustment: The company is testing new offerings like chicken sandwiches and tenders to adapt to changing consumer eating habits, particularly under the low-calorie diet trend, ensuring its protein products remain appealing.
- Strong Sales Performance: In its fourth-quarter report, McDonald's revealed a same-store sales increase of 5.7%, surpassing analysts' expectations of 3.9%, indicating the company's ability to maintain attractiveness in a competitive market.
- Future Monitoring: The company is closely monitoring changes in consumer snacking habits and preferences for lower-sugar beverages to timely adjust its product mix, ensuring competitiveness in the market influenced by GLP-1 drugs.
See More
Novo Nordisk Expands Manufacturing in Ireland for Wegovy
- Capacity Expansion: Novo Nordisk plans to expand its manufacturing facility in Ireland's midlands to meet international demand for its weight-loss drug Wegovy, signaling confidence in the product's global prospects.
- Growing Market Demand: As demand for Wegovy increases outside the U.S., Novo's expansion will enhance its competitiveness in the global weight-loss market, further solidifying its market position.
- Investment Amount Undisclosed: Although CEO Mike Doustdar did not disclose the specific investment amount, this move indicates the company's optimistic outlook on Wegovy's future sales potential, likely attracting more investor interest.
- Strategic Positioning: This expansion not only responds to current market demands but may also lay the groundwork for Novo Nordisk's long-term growth globally, strengthening its strategic positioning in the pharmaceutical industry.
See More
Eli Lilly and Novo Nordisk's Weight Loss Drug Competition
- Market Share Shift: Since June 2024, prescriptions for Novo Nordisk's GLP-1 drugs have declined in the U.S., while Eli Lilly's market share has risen to 60%, demonstrating its strong competitive position in the weight loss drug market.
- Clinical Trial Results: Eli Lilly's Zepbound outperformed Novo Nordisk's Wegovy in head-to-head trials, with participants losing an average of 50 pounds over 72 weeks compared to Wegovy's 33 pounds, further solidifying Lilly's leadership in the weight loss drug sector.
- Infrastructure Investment: Since 2020, Eli Lilly has committed over $50 billion to new manufacturing sites and expansions, announcing 10 U.S. facilities to meet growing market demand and ensure future supply capabilities.
- New Drug Approval Outlook: Eli Lilly's oral weight loss drug orforglipron is awaiting regulatory approval, with a decision expected by April 10, which, if approved, could provide a significant competitive advantage and further reinforce Lilly's market leadership.
See More
Eli Lilly and Novo Nordisk Compete in Weight Loss Drug Market
- Market Share Shift: Eli Lilly began surpassing Novo Nordisk in the U.S. market in June 2024, currently holding a 60% market share while Novo's prescriptions have declined, indicating Eli's strong growth momentum in the weight loss drug sector.
- Product Efficacy Comparison: Eli's Zepbound demonstrated an average weight loss of 50 pounds over 72 weeks, significantly outperforming Novo's Wegovy, which resulted in a 33-pound loss, providing robust support for Eli's market leadership.
- Infrastructure Investment: Since 2020, Eli has committed over $50 billion to new and expanded manufacturing facilities, announcing 10 new sites in the U.S. to meet the surging demand for weight loss drugs, further solidifying its market position.
- New Product Approval: Novo's oral Wegovy received FDA approval, and while Eli's oral weight loss candidate orforglipron is also under review, its potential approval could provide Eli with a significant competitive edge, potentially reshaping the market landscape.
See More
Novo Nordisk to Increase Investment in Ireland for Wegovy Production
- Investment Expansion: Novo Nordisk plans to expand its manufacturing site in Athlone, Ireland, to produce its newly approved oral weight loss drug Wegovy, aiming to cater to markets outside the U.S., demonstrating the company's commitment to global market presence.
- Strong Market Performance: Since its U.S. launch in January, Wegovy has attracted over 45,000 patients, marking one of the most successful pharmaceutical rollouts in history, reflecting its significant potential in the weight loss market.
- Future Revenue Outlook: Despite projecting a 13% year-over-year decline in revenue for 2026 due to increased competition and patent expirations, the company's decision to invest in Ireland indicates confidence in future growth prospects.
- Regulatory Filing Progress: Novo Nordisk plans to submit regulatory filings for Wegovy in the EU and other regions in the second half of 2025, further expanding its market share and showcasing its proactive strategy in the face of competition.
See More
Novo Nordisk Launches Wegovy in Vials to Compete
- Intensifying Market Competition: Novo Nordisk plans to launch its Wegovy drug in vials to counteract pressure from rival Eli Lilly in the rapidly growing weight-loss market, especially after Lilly's introduction of vials for Zepbound in 2024 led to a surge in demand and shortages of its injector pens.
- Flexible Dosing Advantage: The new vial format will offer more flexible dosing compared to prefilled injector pens, although patients will need to manually draw the medication into a syringe, a change aimed at meeting the broader needs of obesity patients and aligning with Novo Nordisk's long-term strategic goals.
- Sales Outlook Downgrade: Novo Nordisk expects adjusted sales growth for 2026 to decline by 5% to 13%, primarily due to the impact of the U.S. “Most Favored Nations” agreement and the expiration of the semaglutide molecule patent in certain international markets, which will negatively affect the company's future revenue.
- Legal Action Update: Novo Nordisk recently filed a lawsuit against Hims & Hers, demonstrating the company's proactive stance in protecting its market share and intellectual property, even as its stock price fell by 0.82% to $48.34 at the time of publication, reflecting market concerns about its future performance.
See More
McDonald's CEO Faces Challenge from GLP-1 Weight-Loss Drugs
- Market Adaptation: McDonald's CEO Chris Kempczinski noted that while the adoption of GLP-1 drugs is increasing, it has not yet materially impacted the company's business, demonstrating resilience in the face of new competition.
- Product Strategy Adjustment: The company is testing new offerings like chicken sandwiches and tenders to adapt to changing consumer eating habits, particularly under the low-calorie diet trend, ensuring its protein products remain appealing.
- Strong Sales Performance: In its fourth-quarter report, McDonald's revealed a same-store sales increase of 5.7%, surpassing analysts' expectations of 3.9%, indicating the company's ability to maintain attractiveness in a competitive market.
- Future Monitoring: The company is closely monitoring changes in consumer snacking habits and preferences for lower-sugar beverages to timely adjust its product mix, ensuring competitiveness in the market influenced by GLP-1 drugs.
See More
Novo Nordisk Expands Manufacturing in Ireland for Wegovy
- Capacity Expansion: Novo Nordisk plans to expand its manufacturing facility in Ireland's midlands to meet international demand for its weight-loss drug Wegovy, signaling confidence in the product's global prospects.
- Growing Market Demand: As demand for Wegovy increases outside the U.S., Novo's expansion will enhance its competitiveness in the global weight-loss market, further solidifying its market position.
- Investment Amount Undisclosed: Although CEO Mike Doustdar did not disclose the specific investment amount, this move indicates the company's optimistic outlook on Wegovy's future sales potential, likely attracting more investor interest.
- Strategic Positioning: This expansion not only responds to current market demands but may also lay the groundwork for Novo Nordisk's long-term growth globally, strengthening its strategic positioning in the pharmaceutical industry.
See More
Eli Lilly and Novo Nordisk's Weight Loss Drug Competition
- Market Share Shift: Since June 2024, prescriptions for Novo Nordisk's GLP-1 drugs have declined in the U.S., while Eli Lilly's market share has risen to 60%, demonstrating its strong competitive position in the weight loss drug market.
- Clinical Trial Results: Eli Lilly's Zepbound outperformed Novo Nordisk's Wegovy in head-to-head trials, with participants losing an average of 50 pounds over 72 weeks compared to Wegovy's 33 pounds, further solidifying Lilly's leadership in the weight loss drug sector.
- Infrastructure Investment: Since 2020, Eli Lilly has committed over $50 billion to new manufacturing sites and expansions, announcing 10 U.S. facilities to meet growing market demand and ensure future supply capabilities.
- New Drug Approval Outlook: Eli Lilly's oral weight loss drug orforglipron is awaiting regulatory approval, with a decision expected by April 10, which, if approved, could provide a significant competitive advantage and further reinforce Lilly's market leadership.
See More
Eli Lilly and Novo Nordisk Compete in Weight Loss Drug Market
- Market Share Shift: Eli Lilly began surpassing Novo Nordisk in the U.S. market in June 2024, currently holding a 60% market share while Novo's prescriptions have declined, indicating Eli's strong growth momentum in the weight loss drug sector.
- Product Efficacy Comparison: Eli's Zepbound demonstrated an average weight loss of 50 pounds over 72 weeks, significantly outperforming Novo's Wegovy, which resulted in a 33-pound loss, providing robust support for Eli's market leadership.
- Infrastructure Investment: Since 2020, Eli has committed over $50 billion to new and expanded manufacturing facilities, announcing 10 new sites in the U.S. to meet the surging demand for weight loss drugs, further solidifying its market position.
- New Product Approval: Novo's oral Wegovy received FDA approval, and while Eli's oral weight loss candidate orforglipron is also under review, its potential approval could provide Eli with a significant competitive edge, potentially reshaping the market landscape.
See More
