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Can Novo Nordisk Hold Its Edge as the GLP-1 Battle With LLY Heats Up?
ZACKS· 2025-09-19 15:55
Core Insights - The global GLP-1 market is experiencing significant attention due to its multi-billion-dollar potential, primarily led by Novo Nordisk and Eli Lilly with their respective products targeting type II diabetes and obesity [1] Competitive Landscape - Eli Lilly and Novo Nordisk have intensified competition, with Eli Lilly's orforglipron showing superior results in A1C and body weight reduction compared to Novo Nordisk's Rybelsus, although orforglipron had higher discontinuation rates due to gastrointestinal side effects [2] - Novo Nordisk's Ozempic demonstrated a 23% reduction in the risk of major adverse cardiovascular events (MACE) compared to Eli Lilly's Trulicity, along with a 25% reduction in a broader composite endpoint [4][10] - Novo Nordisk received EU approval to add cardiovascular benefits to the Rybelsus label, with a 14% reduction in MACE, while FDA review for a similar label expansion is pending [5] Financial Performance - Eli Lilly's Mounjaro and Zepbound generated combined sales of $14.7 billion in the first half of 2025, accounting for 52% of the company's total revenues, indicating a significant market share impact on Novo Nordisk [6] - Novo Nordisk's stock has underperformed, losing 28.1% year-to-date compared to the industry's 0.5% growth [8] Stock Valuation and Estimates - Novo Nordisk's shares are trading at a forward price/earnings ratio of 15.43, higher than the industry average of 14.83, but significantly below its five-year mean of 29.25 [12] - Earnings estimates for 2025 have decreased from $3.98 to $3.85 per share, and for 2026 from $4.56 to $4.07 over the past 60 days, indicating a downward trend in expectations [15]
Eli Lilly's Oral GLP-1 Breakthrough Could Change Everything
MarketBeat· 2025-09-18 19:25
Core Viewpoint - Eli Lilly and Company is a leading player in the GLP-1 market, which is significantly impacting the management of type 2 diabetes and obesity, and has shown strong stock performance over the past year [1][8]. Stock Performance - LLY stock has increased by 10% in the last month due to potential FDA fast-tracking of its oral GLP-1 candidate, which could redefine market access and cost dynamics [2][4]. - The current stock price is $761.52, with a 12-month price forecast of $939.61, indicating a potential upside of 23.73% [3]. Market Dynamics - The oral GLP-1 solution is seen as a game-changer for patients who prefer not to use injections, potentially expanding the GLP-1 market significantly [2][4]. - Eli Lilly is ahead in the development of oral GLP-1 solutions compared to competitors, with the FDA considering a fast-track review process [4][8]. Strategic Investments - Eli Lilly has made a strategic $27 billion investment in U.S. manufacturing, including a $5 billion commitment to build a manufacturing plant in Virginia, which aims to enhance domestic production and address supply chain vulnerabilities [6][7]. - This investment is expected to lower costs and improve insurance coverage for weight loss treatments, which are currently not widely covered [5][6]. Competitive Landscape - Eli Lilly faces increasing competition in the GLP-1 market, particularly from Novo Nordisk, but maintains an edge in drug development speed and manufacturing scale [8]. - Despite competition, the long-term growth story for Eli Lilly remains intact, supported by its diverse pipeline beyond GLP-1 drugs, including oncology and antibody-drug conjugates [11]. Financial Metrics - The company has a dividend yield of 0.79% with an annual dividend of $6.00, and has increased its dividend for 11 consecutive years, maintaining a sustainable payout ratio of 39.22% [10][13]. - LLY stock trades at 32 times forward earnings, which is considered expensive compared to other large-cap pharmaceutical companies but offers good value relative to its historical average [12].
Entera Bio Unveils Promising PK Data for First Oral GLP-2 Therapy
ZACKS· 2025-09-18 13:45
Core Insights - Entera Bio Ltd. (ENTX) has reported promising pharmacokinetic data for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS) [1][4] - The therapy is being developed in collaboration with OPKO Health and could provide a significant alternative to the current treatment, Gattex, which requires daily injections [2][11] Group 1: Therapy Development - OPK-8801003 combines OPKO Health's long-acting GLP-2 analog with Entera's N-Tab oral peptide platform, potentially transforming treatment for approximately 30,000 SBS patients in the U.S. and Europe [2][12] - The therapy demonstrated a plasma half-life of about 15 hours, which is 18 times longer than the 0.85-hour half-life of the current injection option [9][10] - Entera's oral therapy achieved peak plasma concentrations of nearly 200 ng/ml, significantly higher than the 36.8 ng/ml for subcutaneous teduglutide [10] Group 2: Market Potential - The SBS market is valued at nearly $800 million annually, and Entera's oral GLP-2 candidate could capture a share of this market by addressing the limitations of existing treatments [5][13] - The positive pharmacokinetic results not only advance the SBS program but also validate Entera's broader N-Tab oral peptide platform, indicating strong commercial potential [4][13] Group 3: Stock Performance and Investor Sentiment - Year-to-date, Entera Bio's stock has decreased by 15.5%, contrasting with a 3.1% gain in the industry and a 13.4% increase in the S&P 500 [3] - The encouraging pharmacokinetic data is expected to improve investor sentiment, as it serves as a de-risking milestone for the company's pipeline [4][5]
Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, reduced A1C by an average of 2.2% in a Phase 3 trial of children and adolescents with type 2 diabetes
Prnewswire· 2025-09-17 22:01
Core Insights - Eli Lilly's Mounjaro (tirzepatide) demonstrated significant efficacy in treating type 2 diabetes in children and adolescents, meeting primary and secondary endpoints in the SURPASS-PEDS trial [1][2][5] - The trial results indicate a promising opportunity for improving long-term health outcomes for young patients with type 2 diabetes [2][5] Summary by Sections Trial Results - Mounjaro achieved a 2.2% reduction in A1C from a baseline of 8.05% at 30 weeks, significantly outperforming placebo [2][3] - 86.1% of participants on the 10 mg dose reached the target A1C of 6.5% [2][3] - The 10 mg dose also resulted in an average BMI reduction of 11.2% at 30 weeks, with improvements sustained through 52 weeks [2][3] Safety Profile - The safety and tolerability of Mounjaro were consistent with previous adult studies, with common adverse events including diarrhea (25%), nausea (22%), and vomiting (16%) [5] - No severe hypoglycemia episodes were reported, and the rate of Level 2 hypoglycemia was 15.4% in Mounjaro groups compared to 5.9% in placebo [5] Regulatory and Market Implications - Eli Lilly has submitted the SURPASS-PEDS results to global regulatory agencies for an expanded indication for Mounjaro [6] - The increasing prevalence of type 2 diabetes in children highlights the need for effective treatment options, positioning Mounjaro as a potential solution in an underserved market [5] Background on Mounjaro - Mounjaro is a GIP/GLP-1 dual receptor agonist that aids in glycemic control and weight management by decreasing calorie intake and improving insulin sensitivity [7][8] - It is already approved for adults with type 2 diabetes and obesity, with ongoing studies for chronic kidney disease and obesity-related morbidity/mortality [7][8]
Lilly's oral GLP-1, orforglipron, superior to oral semaglutide in head-to-head trial
Prnewswire· 2025-09-17 13:00
Core Insights - The primary endpoint indicates that orforglipron significantly reduced A1C levels by 2.2% compared to a 1.4% reduction with oral semaglutide at the highest doses [1] - Participants receiving the highest dose of orforglipron experienced an average weight loss of 19.7 lbs, which is approximately 9.2% of their body weight [1]
Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting
Prnewswire· 2025-09-16 23:30
Core Insights - Ascletis Pharma Inc. presented promising results for its oral small molecule GLP-1 receptor agonist ASC30, demonstrating significant body weight reduction in participants with obesity during a 28-day multiple ascending dose study [3][4][9] Group 1: Study Results - ASC30 achieved a 6.5% placebo-adjusted mean body weight reduction from baseline in MAD cohort 2 after 28 days of treatment [4] - In MAD cohort 1, ASC30 showed a 4.5% placebo-adjusted mean body weight reduction from baseline after the same treatment duration [4] - The study indicated no signs of a plateau effect at Day 29, suggesting continued efficacy [4] Group 2: Safety and Tolerability - ASC30 was found to be safe and well tolerated, with only mild to moderate gastrointestinal adverse events reported [2][6] - No serious adverse events were recorded, and there were no Grade 3 or higher adverse events observed [7] - The titration strategy from 2 mg to 5 mg in MAD cohort 1 resulted in zero incidence of vomiting, indicating an appropriate escalation pace [6] Group 3: Pharmacokinetics - Higher doses of ASC30 (20 mg and 40 mg) demonstrated a superior pharmacokinetic profile, with a positive correlation between the area under the curve (AUC) and body weight reduction [5] - The pharmacokinetic data showed that the maximum concentration (Cmax) for MAD cohort 2 was 397 ng/mL, compared to 272 ng/mL for MAD cohort 1 [5] Group 4: Future Outlook - The company anticipates reporting topline results from the 13-week Phase IIa study of ASC30 in the fourth quarter of this year [9] - ASC30 is positioned as a differentiated treatment option for obesity, with both oral and subcutaneous administration routes [10][11]
Lilly's oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine
Prnewswire· 2025-09-16 22:01
Core Insights - Eli Lilly's investigational drug orforglipron shows significant weight loss and cardiometabolic improvements in adults with obesity or overweight, as demonstrated in the Phase 3 ATTAIN-1 trial [1][5][8] Group 1: Study Results - Orforglipron led to an average weight loss of 27.3 lbs (12.4%) at the highest dose after 72 weeks, with all doses meeting the primary endpoint of superior body weight reduction compared to placebo [1][2] - Key secondary endpoints showed that 59.6% of participants on the highest dose lost at least 10% of their body weight, and 39.6% lost at least 15% [1][3] - Among participants with prediabetes, 91% taking orforglipron achieved near-normal blood sugar levels compared to 42% in the placebo group [1][4] Group 2: Cardiovascular Risk Factors - Orforglipron demonstrated clinically meaningful improvements in non-HDL cholesterol, systolic blood pressure, and triglycerides, indicating its potential to reduce cardiovascular risk associated with obesity [1][4] - The highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels by 47.7%, a marker of inflammation [1] Group 3: Safety Profile - The safety profile of orforglipron was consistent with the GLP-1 receptor agonist class, with common adverse events being gastrointestinal-related and generally mild to moderate [4] - The most frequently reported adverse events included nausea (28.9% to 35.9%), constipation (21.7% to 29.8%), diarrhea (21.0% to 23.1%), and vomiting (13.0% to 24.0%) across different doses compared to placebo [4] Group 4: Regulatory and Market Potential - Eli Lilly is advancing orforglipron toward global regulatory submissions for obesity treatment, with action expected as early as next year, and for type 2 diabetes anticipated in 2026 [5][8] - Orforglipron is positioned as a convenient, once-daily oral medication that could be integrated into primary care settings, addressing various health markers for patients with obesity [4][8]
I Own The Gas Pump With Up To 10% Yields
Seeking Alpha· 2025-09-13 14:30
Group 1 - The article promotes a portfolio strategy that generates income without the need for selling assets, aiming to simplify retirement investing [1] - It emphasizes a community-oriented approach to investing, encouraging collaboration and education among investors [2] - The service offers features such as model portfolios, buy/sell alerts, and regular market updates to assist investors [2] Group 2 - The article mentions that the contributors to the service closely monitor their positions and provide exclusive buy and sell alerts to members [4] - It highlights the importance of community and support in the investment process, suggesting that no one should invest alone [2]
The GLP-1 Oral Frontier: Novo Nordisk And Eli Lilly's 100-Year Duel Enters Its Next Chapter
Seeking Alpha· 2025-09-13 10:30
Core Insights - The article emphasizes the importance of identifying deeply undervalued equities with long-term potential that are often overlooked by the market [1]. Investment Strategy - The investment approach is based on managing investments since 1999, which provides a perspective across multiple market cycles [1]. - The analyst has a background in Economics and is pursuing CFA certification, indicating a strong foundation in financial analysis [1]. Market Perspective - The focus is on uncovering investment opportunities that may not be immediately apparent to the broader market, suggesting a contrarian investment strategy [1].
NOVO ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Novo Nordisk A/S and Encourages Investors to Contact the Firm
Globenewswire· 2025-09-11 12:14
Core Viewpoint - A class action lawsuit has been filed against Novo Nordisk A/S for allegedly providing misleading statements about its growth potential and market capabilities, leading to significant investor losses during the specified class period [2][4]. Group 1: Lawsuit Details - The class action lawsuit is on behalf of all individuals and entities who purchased Novo securities between May 7, 2025, and July 28, 2025 [2]. - Investors have until September 30, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [2]. Group 2: Allegations Against Novo - The complaint alleges that Novo made overwhelmingly positive statements while concealing material adverse facts about its growth potential, particularly regarding the compounded GLP-1 market and the likelihood of patients switching to Novo's branded alternatives [4]. - The lawsuit claims that Novo overstated its capability to penetrate the GLP-1 market and achieve continued growth [4]. Group 3: Stock Price Impact - Following Novo's announcement on July 29, 2025, regarding lowered sales and profit outlook due to reduced growth expectations, the company's stock price fell from $69.00 per share on July 28, 2025, to $53.94 per share on July 29, 2025, marking a decline of approximately 21.83% in one day [5].