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Can Eli Lilly's Clinical Momentum Keep the Stock at Record Highs?
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Key Takeaways
Eli Lilly reported phase III data highlighting advances across its diabetes and obesity portfolio.
LLY's Foundayo beat oral semaglutide and Farxiga on A1C reduction and weight-loss measures in studies.
Retatrutide showed up to 28.3% weight loss and improved obesity-related conditions in studies.
Eli Lilly (LLY - Free Report) stock continues to hit new all-time highs as the drugmaker keeps delivering a steady stream of positive clinical updates across its diabetes and obesity portfolio.
LLY shares reached a record high of $1,149.15 on Monday following encouraging clinical results from late-stage studies of Foundayo (orforglipron), its oral GLP-1 therapy, and retatrutide, its investigational triple-hormone receptor agonist that targets the GIP, GLP-1 and glucagon pathways. The latest data presented at the American Diabetes Association Scientific Sessions further reinforced confidence in the company’s cardiometabolic franchise.
Per data from the phase III ACHIEVE-3 head-to-head study, Foundayo outperformed Novo Nordisk’s (NVO - Free Report) oral semaglutide across both blood sugar control and weight-loss measures in adults with type II diabetes (T2D). Patients receiving the highest Foundayo dose achieved greater A1C reductions and significantly higher weight loss than those taking oral semaglutide, while a larger proportion reached normal blood sugar levels.
Foundayo also produced strong results in two additional late-stage studies. In ACHIEVE-2, the drug delivered superior A1C reduction and weight loss compared with AstraZeneca’s Farxiga (dapagliflozin). In ACHIEVE-5, Foundayo significantly improved glycemic control and body weight when added to insulin therapy. Collectively, the data strengthen Lilly’s case for expanding Foundayo into the T2D market, with a regulatory filing planned by the end of the second quarter.
Lilly is also investing heavily in next-generation candidates to maintain continued future profitability. The company recently reported additional phase III results for retatrutide. In the TRIUMPH-1 study, patients receiving the highest dose lost an average of 28.3% of their body weight over 80 weeks, with nearly two-thirds no longer meeting the clinical definition of obesity. Beyond weight reduction, retatrutide demonstrated meaningful improvements in obesity-related conditions, including knee osteoarthritis pain and moderate-to-severe obstructive sleep apnea. In the TRANSCEND-T2D-1 study, the candidate reduced A1C by up to 2% and delivered weight loss of up to 16.8%, with nearly half of the participants achieving normal blood sugar levels.
The latest findings build on positive top-line data Lilly had already reported from both the TRIUMPH-1 and TRANSCEND-T2D-1 studies earlier this year. Those earlier results established retatrutide’s ability to drive substantial weight loss and glycemic control. At the same time, the newly released detailed analyses further highlighted benefits across multiple obesity-related complications and cardiovascular risk factors. Together, the data continue to strengthen expectations that retatrutide could become one of Lilly’s most important future growth drivers.
Investors remain encouraged by Lilly’s ability to expand its leadership beyond blockbuster products like Mounjaro (T2D) and Zepbound (obesity), while simultaneously advancing next-generation therapies that could support long-term growth.
Lilly's Clinical Edge Continues to Pressure Novo Nordisk
Novo Nordisk remains Lilly’s fiercest rival in the obesity and diabetes markets. Novo Nordisk is also expanding its portfolio through higher-dose semaglutide products, label expansions and pipeline candidates such as CagriSema and amycretin.
However, Lilly’s recent string of clinical wins appears to be shifting competitive momentum in its favor. Foundayo’s superiority over Rybelsus in a direct phase III comparison and retatrutide’s impressive efficacy profile suggest Lilly could continue capturing market share across both diabetes and obesity. LLY now possesses a broad portfolio spanning injectable and oral therapies while also advancing next-generation treatments that may offer greater efficacy than currently available options.
LLY Faces Rising Pressure From Next-Generation GLP-1 Rivals
The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity.
Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.
Structure Therapeutics’ phase II ACCESS study on its orally administered GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026.
LLY’s Stock Price, Valuation and Estimates
Shares of Eli Lilly have gained 6.9% year to date compared with the industry’s 4.4% growth. During the same time frame, the company has also outperformed the sector but underperformed the S&P 500, as seen in the chart below.
LLY Stock Price Movement
Image Source: Zacks Investment Research
From a valuation standpoint, LLY stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 29.05 forward earnings, higher than 17.68 for the industry. However, the stock is trading below its five-year mean of 34.56.
LLY Stock Valuation
Image Source: Zacks Investment Research
Estimates for Eli Lilly’s 2026 earnings have improved from $35.47 to $35.67 per share in the past 30 days, and estimates for 2027 earnings have improved from $44.50 to $44.56 per share over the same time frame.
Image: Bigstock
Can Eli Lilly's Clinical Momentum Keep the Stock at Record Highs?
Key Takeaways
Eli Lilly (LLY - Free Report) stock continues to hit new all-time highs as the drugmaker keeps delivering a steady stream of positive clinical updates across its diabetes and obesity portfolio.
LLY shares reached a record high of $1,149.15 on Monday following encouraging clinical results from late-stage studies of Foundayo (orforglipron), its oral GLP-1 therapy, and retatrutide, its investigational triple-hormone receptor agonist that targets the GIP, GLP-1 and glucagon pathways. The latest data presented at the American Diabetes Association Scientific Sessions further reinforced confidence in the company’s cardiometabolic franchise.
Per data from the phase III ACHIEVE-3 head-to-head study, Foundayo outperformed Novo Nordisk’s (NVO - Free Report) oral semaglutide across both blood sugar control and weight-loss measures in adults with type II diabetes (T2D). Patients receiving the highest Foundayo dose achieved greater A1C reductions and significantly higher weight loss than those taking oral semaglutide, while a larger proportion reached normal blood sugar levels.
Foundayo also produced strong results in two additional late-stage studies. In ACHIEVE-2, the drug delivered superior A1C reduction and weight loss compared with AstraZeneca’s Farxiga (dapagliflozin). In ACHIEVE-5, Foundayo significantly improved glycemic control and body weight when added to insulin therapy. Collectively, the data strengthen Lilly’s case for expanding Foundayo into the T2D market, with a regulatory filing planned by the end of the second quarter.
Lilly is also investing heavily in next-generation candidates to maintain continued future profitability. The company recently reported additional phase III results for retatrutide. In the TRIUMPH-1 study, patients receiving the highest dose lost an average of 28.3% of their body weight over 80 weeks, with nearly two-thirds no longer meeting the clinical definition of obesity. Beyond weight reduction, retatrutide demonstrated meaningful improvements in obesity-related conditions, including knee osteoarthritis pain and moderate-to-severe obstructive sleep apnea. In the TRANSCEND-T2D-1 study, the candidate reduced A1C by up to 2% and delivered weight loss of up to 16.8%, with nearly half of the participants achieving normal blood sugar levels.
The latest findings build on positive top-line data Lilly had already reported from both the TRIUMPH-1 and TRANSCEND-T2D-1 studies earlier this year. Those earlier results established retatrutide’s ability to drive substantial weight loss and glycemic control. At the same time, the newly released detailed analyses further highlighted benefits across multiple obesity-related complications and cardiovascular risk factors. Together, the data continue to strengthen expectations that retatrutide could become one of Lilly’s most important future growth drivers.
Investors remain encouraged by Lilly’s ability to expand its leadership beyond blockbuster products like Mounjaro (T2D) and Zepbound (obesity), while simultaneously advancing next-generation therapies that could support long-term growth.
Lilly's Clinical Edge Continues to Pressure Novo Nordisk
Novo Nordisk remains Lilly’s fiercest rival in the obesity and diabetes markets. Novo Nordisk is also expanding its portfolio through higher-dose semaglutide products, label expansions and pipeline candidates such as CagriSema and amycretin.
However, Lilly’s recent string of clinical wins appears to be shifting competitive momentum in its favor. Foundayo’s superiority over Rybelsus in a direct phase III comparison and retatrutide’s impressive efficacy profile suggest Lilly could continue capturing market share across both diabetes and obesity. LLY now possesses a broad portfolio spanning injectable and oral therapies while also advancing next-generation treatments that may offer greater efficacy than currently available options.
LLY Faces Rising Pressure From Next-Generation GLP-1 Rivals
The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity.
Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.
Structure Therapeutics’ phase II ACCESS study on its orally administered GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026.
LLY’s Stock Price, Valuation and Estimates
Shares of Eli Lilly have gained 6.9% year to date compared with the industry’s 4.4% growth. During the same time frame, the company has also outperformed the sector but underperformed the S&P 500, as seen in the chart below.
LLY Stock Price Movement
From a valuation standpoint, LLY stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 29.05 forward earnings, higher than 17.68 for the industry. However, the stock is trading below its five-year mean of 34.56.
LLY Stock Valuation
Estimates for Eli Lilly’s 2026 earnings have improved from $35.47 to $35.67 per share in the past 30 days, and estimates for 2027 earnings have improved from $44.50 to $44.56 per share over the same time frame.
LLY Estimate Movement
Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.