Lilly Eli & Co - LLY STOCK NEWS

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.