Eli Lilly's next-generation weight loss drug application extension to 2027, stock price fell slightly before opening
On Thursday local time, the American pharmaceutical giant Eli Lilly announced that the company plans to submit a marketing application for the next-generation weight loss drug Retatrutide to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027. At the same time, the drug completed two phase III clinical trials and achieved positive results. Before the U.S. stock market opened, Eli Lilly's stock price fell about 0.35%. Eli Lilly has previously said it would submit a marketing application for the once-weekly injection of a weight-loss drug as soon as this year.
On Thursday local time, the American pharmaceutical giant Eli Lilly announced that the company plans to submit a marketing application for the next-generation weight loss drug Retatrutide to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027. At the same time, the drug completed two phase III clinical trials and achieved positive results. Before the U.S. stock market opened, Eli Lilly's stock price fell about 0.35%. Eli Lilly has previously said it would submit a marketing application for the once-weekly injection of a weight-loss drug as soon as this year. However, Eli Lilly's latest statement stated that the company needs more time to collect and verify the production and quality control data required by regulatory agencies, so the listing application time will be delayed. This is also the reason why the stock price fell slightly. It is reported that Retatrutide is a drug that acts on three metabolic hormones: GLP-1, GIP and glucagon, which gives it more weight loss advantages than Eli Lilly's Zepbound and Novo Nordisk's Wegovy. In addition, in two independently conducted phase III clinical trials, Retatrutide achieved the primary research endpoint: it not only achieved significant weight loss, but also improved a key blood sugar indicator in patients with obesity and severe complications. The trial population included obese adults with type 2 diabetes and established cardiovascular disease. Kenneth Custer, president of Lilly's cardiometabolic health business, said that based on the data currently obtained, the company believes it has the clinical evidence required to submit a marketing application for Retatrutide to global regulatory agencies. The proposed indications include obesity, knee osteoarthritis pain and obstructive sleep apnea. Custer emphasized: "Retatrutide has achieved positive results in five phase III clinical trials and demonstrated strong efficacy. We believe that it has the potential to become an important therapeutic tool in the management of cardiometabolic diseases in the future." Among them, one trial showed that patients with obesity and type 2 diabetes experienced an average weight loss of up to 20.8%, or approximately 50 pounds (approximately 22.7 kilograms), after 80 weeks of treatment with Retatrutide. Eli Lilly noted that such patients often have a more difficult time losing weight. Another trial showed that patients with severe obesity and established cardiovascular disease experienced an average weight loss of up to 22.6%, or about 55.8 pounds (about 25.3 kilograms), after 80 weeks of treatment. In addition, Retatrutide can significantly improve multiple cardiovascular risk indicators in patients. Eli Lilly said that the adverse reactions observed in the two trials were consistent with the results of previous studies, mainly including diarrhea, nausea and constipation, which are also the most common adverse reactions of the entire GLP-1 class of drugs. So far, Retatrutide has achieved positive results in five phase III clinical trials. Eli Lilly is building it as the next core product in the company's obesity pipeline, following the injectable weight-loss drug Zepbound and the newly launched oral weight-loss drug Foundayo. A report released by TD Cowen analysts in January this year estimated that sales of Retatrutide are expected to reach $3.8 billion by 2030. Retatrutide is also an important product for Eli Lilly to solidify its leading position in the fast-growing weight loss and diabetes treatment markets. Currently, Eli Lilly and Novo Nordisk compete fiercely in this market, and many analysts predict that the market size is expected to reach approximately US$100 billion by the 2030s.