Welcome to our dedicated page for Lilly Eli & Co news (Ticker: LLY), a resource for investors and traders seeking the latest updates and insights on Lilly Eli & Co stock.
Lilly Eli & Co (LLY) delivers innovative healthcare solutions through cutting-edge pharmaceutical research and global therapeutic development. This news hub provides investors and industry professionals with timely updates on corporate milestones, regulatory developments, and scientific advancements.
Access official press releases, earnings reports, and analysis of key initiatives across diabetes, oncology, and immunology research. Our curated collection ensures you stay informed about FDA decisions, partnership announcements, and manufacturing expansions without promotional bias.
Discover updates on clinical trial progress, sustainability efforts, and market leadership in biotechnology. Bookmark this page for streamlined access to verified information that supports informed decision-making in the evolving pharmaceutical landscape.
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the biologic license application for mirikizumab, a treatment for ulcerative colitis (UC). The FDA's letter highlighted manufacturing issues but did not raise concerns about clinical data or safety. Lilly expressed confidence in mirikizumab's Phase 3 clinical data and aims for a swift resolution with the FDA. Recently, mirikizumab was approved in Japan as a first-in-class treatment for adults with UC, and the European Medicines Agency's Committee has given a positive opinion for its use in Europe. Regulatory decisions are anticipated globally in 2023.
Eli Lilly and Company (NYSE: LLY) will announce its first-quarter 2023 financial results on April 27, 2023, followed by a conference call at 10 a.m. Eastern time. The event will provide insights into the company’s financial performance.
Investors and the public can access a live webcast of the call through Lilly's investor relations website. A replay will also be available post-event. With nearly 150 years in the industry, Lilly is committed to delivering innovative medicines and clinical trials, focusing on significant health challenges including diabetes, obesity, Alzheimer’s disease, and various cancers.
Eli Lilly and Company (NYSE: LLY) announced that its oncology portfolio data will be presented at the AACR Annual Meeting in Orlando from April 14-19, 2023. Key presentations include Phase 1 results for LY3537982, a KRAS G12C inhibitor, and LY3410738, an IDH inhibitor, alongside a Phase 2 study of Verzenio for treating metastatic castration-resistant prostate cancer. Preclinical data for Jaypirca's unique binding mechanism will also be shared. The sessions will discuss significant new findings that could impact future treatments.
Eli Lilly's solanezumab has failed to show efficacy in slowing cognitive decline in preclinical Alzheimer's disease, as reported in the A4 Study. The trial, involving over 1,100 participants aged 65 to 85, demonstrated that solanezumab did not meet primary or secondary endpoints, nor did it clear amyloid plaques in the brain. Results indicated a cognitive decline of -1.69 for solanezumab compared to -1.4 for the placebo (p-value 0.26). Lilly continues its commitment to Alzheimer’s research, focusing on new treatments like donanemab and remternetug, which are currently in Phase 3 trials.
The U.S. FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin), which aims to lower blood sugar in children aged 10-17 with type 2 diabetes. This application is supported by phase III results from the DINAMO trial, showing a significant A1c reduction of 0.84% compared to placebo over 26 weeks. If approved, Jardiance would be the first SGLT2 inhibitor for this age group. Currently, type 2 diabetes is increasingly affecting youth, impacting approximately 39,000 people under 20 in the U.S. Safety data aligns with existing profiles, with no new risks identified.
Eli Lilly has received FDA approval for an expanded indication of Verzenio (abemaciclib) for adult patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence. This expansion allows the identification of eligible patients based solely on nodal status, tumor size, and tumor grade, removing the previous requirement of a Ki-67 score. Supported by four-year data from the monarchE trial, Verzenio in combination with endocrine therapy reduced recurrence risk by 35%, resulting in an 85.5% invasive disease-free survival rate after four years. The approval could significantly impact treatment options for a large patient population.
Eli Lilly and Company (NYSE: LLY) has announced significant price reductions for its insulins, cutting prices by 70% for its most commonly prescribed insulin products. Effective May 1, 2023, the list price of Insulin Lispro Injection will drop to $25 per vial, making it the lowest-priced mealtime insulin available. Additionally, Lilly will cap out-of-pocket costs at $35 per month for patients using its insulin products. This initiative aims to improve access to affordable insulin amid ongoing challenges in the U.S. healthcare system, with a public awareness campaign set to launch soon.
Eli Lilly and Company (NYSE: LLY) will attend Cowen's 43rd Annual Health Care Conference on March 6, 2023. Mike Mason, executive vice president and president of Lilly Diabetes and Obesity, will engage in a fireside chat at 1:30 p.m. Eastern time. Interested investors and stakeholders can access the live audio webcast on Lilly's Investor website, with a replay available for 90 days thereafter. Lilly has been at the forefront of medical innovation for nearly 150 years, helping over 47 million people worldwide by advancing diabetes care, combating obesity, and tackling severe health challenges like Alzheimer's disease and difficult cancers.
Eli Lilly (NYSE: LLY) has partnered with International Agencies (Bangladesh) Ltd. (IABL) to supply human insulin active pharmaceutical ingredient (API) at a reduced price to increase accessibility for nearly one million diabetes patients in Bangladesh by 2030. IABL plans to produce insulin vials and cartridges by 2025 exclusively for the local market. This collaboration is part of Lilly's 30x30 initiative aimed at providing quality healthcare to 30 million people in low-resource settings. The IDF Diabetes Atlas indicates that diabetes cases in Bangladesh are projected to rise from 13.1 million to 22.3 million by 2045.