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.
Eli Lilly and Company (NYSE: LLY) generates frequent news across cardiometabolic health, oncology, immunology, obesity and manufacturing expansion. This page aggregates recent press releases and third-party coverage so readers can follow how Lilly’s medicines, clinical programs and corporate actions are evolving over time.
Recent updates show Lilly reporting Phase 3 results for multiple late-stage assets. In obesity and cardiometabolic health, the company has shared topline data from ATTAIN-MAINTAIN, a Phase 3 trial of orforglipron, an investigational once-daily oral GLP-1 receptor agonist, for weight maintenance after prior treatment with injectable incretin therapies. Lilly has also reported results from TRIUMPH-4, a Phase 3 trial of retatrutide, an investigational triple agonist targeting GIP, GLP-1 and glucagon receptors, in adults with obesity or overweight and knee osteoarthritis, with co-primary endpoints in weight loss and pain reduction.
In immunology, Lilly has announced positive topline results from the TOGETHER-PsA Phase 3b trial, which evaluated concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) versus Taltz alone in adults with active psoriatic arthritis and obesity or overweight with at least one weight-related condition. The company reports that the combination met the primary endpoint and all key secondary endpoints, supporting an integrated approach to treating psoriatic arthritis and obesity.
Oncology news includes updated EMBER-3 data for Inluriyo (imlunestrant) as monotherapy and in combination with Verzenio (abemaciclib) in ER-positive, HER2-negative advanced breast cancer, and Phase 3 BRUIN CLL-313 results showing that Jaypirca (pirtobrutinib) significantly reduced the risk of progression or death versus chemoimmunotherapy in treatment-naïve CLL/SLL without 17p deletions.
Corporate and strategic news items cover Lilly’s planned acquisition of Ventyx Biosciences, completion of the Adverum Biotechnologies tender offer, a strategic collaboration with Aktis Oncology, and a major manufacturing investment in a new active pharmaceutical ingredient facility in Huntsville, Alabama. Investors and observers can use this news feed to monitor clinical milestones, regulatory submissions, acquisitions, collaborations, financing activities and manufacturing expansions related to LLY.
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Eli Lilly reported Q1 2023 revenue of $6.96 billion, down 11% year-over-year, primarily due to a significant decline in COVID-19 antibody sales. Excluding these revenues, the company saw a 10% increase, driven by strong performances from its growth products like Mounjaro, Trulicity, Verzenio, and Jardiance. Q1 2023 EPS decreased 29% to $1.49 on a reported basis and 38% to $1.62 on a non-GAAP basis. The company raised its 2023 EPS guidance, now forecasting reported EPS between $8.18 to $8.38, reflecting positive core business growth and successful pipeline advancements, including FDA approvals. Eli Lilly's new products contributed $573.6 million to revenue, with growth products revenue rising 18% to $4.56 billion.
Eli Lilly (NYSE: LLY) announced remarkable results from its SURMOUNT-2 trial, demonstrating that tirzepatide led to weight reductions of up to 15.7% (34.4 lb or 15.6 kg) in participants with obesity or overweight and type 2 diabetes over 72 weeks. The study met all co-primary and key secondary objectives, indicating tirzepatide's superiority over placebo. Notably, 81.6% (10 mg) and 86.4% (15 mg) of participants achieved at least 5% weight reduction, significantly higher than the 30.5% in the placebo group. The safety profile was consistent with previous trials, with gastrointestinal issues being the most common adverse events. Lilly plans to complete the FDA submission for tirzepatide in the coming weeks, expecting regulatory action by late 2023.
Eli Lilly (NYSE: LLY) has announced a definitive agreement to sell its glucagon product BAQSIMI to Amphastar Pharmaceuticals (NASDAQ: AMPH) for $500 million at closing and an additional $125 million after one year. This divestiture aims to enhance the accessibility of BAQSIMI, the first nasal glucagon treatment for severe hypoglycemia in diabetes patients. BAQSIMI generated worldwide sales of $139.3 million in 2022, and the deal is expected to close in Q2 or Q3 2023. Both companies' boards have approved the agreement, which includes potential sales-based milestone payments of up to $450 million. Amphastar plans to invest in BAQSIMI to improve treatment access for those on insulin, aligning with its strategic focus on expanding its diabetes portfolio.
Eli Lilly (NYSE: LLY) announced an unprecedented $3.7 billion investment in manufacturing facilities in Boone County, Indiana. This commitment includes an additional $1.6 billion and the creation of 200 new jobs, totaling up to 700 jobs at the site. The investment marks the largest manufacturing expansion in the company’s history and aims to utilize advanced technology for producing innovative medicines.
Additionally, Lilly will allocate $15 million to the Ivy Tech Foundation over five years, funding 1,000 scholarships for students pursuing careers in pharmaceutical manufacturing. The initiative promotes education and employment for individuals from diverse backgrounds and supports the state's talent pipeline.
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.