Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Company (NYSE: LLY) announced positive results from its SURPASS-1 trial, showcasing tirzepatide's efficacy in reducing A1C and body weight in adults with type 2 diabetes. After 40 weeks, tirzepatide resulted in A1C reductions of up to 2.07% and weight loss of up to 9.5 kg across three doses, compared to placebo. Most participants achieved A1C levels below 7%, with minimal adverse effects similar to existing GLP-1 treatments. Lilly intends to complete the registration process for tirzepatide by the end of 2021, which marks a significant step in diabetes management.

Eli Lilly's tirzepatide demonstrated superior efficacy in reducing A1C levels and body weight compared to semaglutide in the 40-week SURPASS-2 clinical trial. The study enrolled 1,879 adults with type 2 diabetes, showing A1C reductions of up to -2.46% and weight reductions of up to -12.4 kg across three tirzepatide doses. Notably, 60% of participants on the highest dose achieved significant endpoints without hypoglycemia. The safety profile was consistent with GLP-1 receptor agonists, with gastrointestinal issues being the most common side effects. Lilly aims for regulatory submission by the end of 2021.

The FDA has granted Breakthrough Therapy designation to Eli Lilly's investigational antibody, donanemab, for treating Alzheimer's disease. This designation accelerates development for drugs showing significant improvement over existing therapies. Preliminary clinical evidence from the Phase 2 TRAILBLAZER-ALZ trial supports this designation. Lilly plans to submit a biologics license application based on these findings later this year. Donanemab targets modified beta amyloid and is currently undergoing further evaluation in a Phase 3 trial, TRAILBLAZER-ALZ 2.

Eli Lilly has launched the Think Talk Treat Migraine™ initiative aimed at improving migraine care and diagnosis. The initiative addresses the gap in recognizing migraine symptoms and facilitates better communication between patients and primary care providers.
Currently in pilot in four metropolitan areas, it includes tools like a checklist and digital migraine management platform, VEGA™. Despite high prevalence, only a small percentage of migraine sufferers receive adequate treatment. Lilly aims to increase awareness and support effective management of migraine.

Eli Lilly and Company (NYSE: LLY) announced a head-to-head clinical trial comparing Emgality (galcanezumab-gnlm), a monthly injectable, with Nurtec ODT (rimegepant), an oral medication, to assess their effectiveness in preventing migraines. This Phase 4 study will evaluate patients diagnosed with episodic migraine, focusing on the reduction of monthly migraine headache days. The trial aims to provide insights for better treatment decisions. Emgality is recognized for its efficacy in achieving substantial reductions in migraine frequency and has supported over 700,000 patients.

Eli Lilly and Company (NYSE: LLY) will participate in the Guggenheim Biopharma Strategy Series on June 18, 2021. The event features a virtual fireside chat with Daniel Skovronsky, M.D., Ph.D., Lilly's Chief Scientific and Medical Officer, at 11:00 a.m. Eastern Time. Investors can access a live audio webcast on Lilly's Investor website, with a replay available for 90 days post-event. Lilly is committed to discovering life-changing medicines and has been a healthcare leader for over a century, enhancing global health and philanthropy.

Eli Lilly and Company (NYSE: LLY) will host a webcast on July 1, 2021, at 10:00 a.m. Eastern Time, to discuss its diabetes portfolio and findings from the tirzepatide SURPASS clinical trial at the American Diabetes Association's Virtual 81st Scientific Sessions. The conference will address next steps for tirzepatide and insights on Lilly's once-weekly basal insulin and early-phase incretins. The event will be accessible via Lilly's investor website, with a replay available afterward.

Eli Lilly announced promising data for Verzenio (abemaciclib) in high-risk early breast cancer and the oral selective estrogen receptor degrader LY3484356 at ASCO 2021. In the Phase 3 monarchE trial, Verzenio combined with endocrine therapy decreased recurrence risk by 38.6% in patients post-neoadjuvant chemotherapy. The trial included 2,056 patients, with a two-year invasive disease-free survival rate of 87.2%. LY3484356's Phase 1a trial showed encouraging safety and efficacy in advanced breast cancer, with a planned Phase 3 study (EMBER-3) to start later this year.