Eli Lilly & Co. develops and commercializes medicines across cardiometabolic disease, oncology, immunology, neuroscience and genetic medicine. Company news commonly covers product and pipeline developments for medicines such as Mounjaro, Zepbound, Foundayo, Omvoh, Verzenio, Jaypirca and Taltz, including clinical data, regulatory approvals and treatment-indication updates.
Lilly updates also include operating results, financial guidance, dividends, business development agreements and manufacturing expansion. Recent company communications highlight investment in active pharmaceutical ingredient capacity and genetic medicine production, alongside recurring disclosures about demand for diabetes, obesity, immune-disease and cancer therapies.
On December 5, 2020, Loxo Oncology at Lilly presented promising results from the LOXO-305 Phase 1/2 BRUIN trial for mantle cell lymphoma (MCL) and other B-cell malignancies at the ASH Annual Meeting. LOXO-305, a non-covalent BTK inhibitor, showed a 52% overall response rate (ORR) among 56 efficacy-evaluable MCL patients, including 14 complete responses. The company plans to initiate a Phase 3 trial in early 2021 to compare LOXO-305 to existing BTK inhibitors. Safety data indicates manageable side effects, positioning LOXO-305 as a potential new treatment option for patients with limited alternatives.
The U.S. government has acquired 650,000 doses of Eli Lilly's bamlanivimab (LY-CoV555) for $812.5 million. This brings total government purchases to 950,000 doses, aimed at treating high-risk COVID-19 patients. Deliveries are expected by January 31, 2021, with at least 350,000 doses in December 2020. The updated agreement is anticipated to contribute approximately $500 million in revenue and 25 cents to earnings per share. Despite its emergency use authorization, safety and efficacy of bamlanivimab remain unproven, inviting scrutiny.
Eli Lilly (NYSE: LLY) will attend the Evercore ISI 3rd Annual HealthCONx Conference on December 1, 2020. Michael Mason, the senior vice president, will engage in a virtual fireside chat at 2:40 p.m. ET. Investors can access the live audio webcast through the 'Webcasts & Presentations' section of Lilly's Investor website, with a replay available for 90 days following the event. Founded over a century ago, Lilly is committed to creating high-quality medicines and improving disease management worldwide.
Health Canada has authorized bamlanivimab (LY-CoV555) for treating adults and pediatric patients (12+) with mild to moderate COVID-19 at high risk of severe illness. This authorization is based on BLAZE-1 trial data, showing reduced viral load and symptom rates. Lilly plans to manufacture up to one million doses by year-end 2020 and is pursuing additional global authorizations. While the FDA granted Emergency Use Authorization for bamlanivimab in the U.S., it remains unapproved for any use, emphasizing the need for careful monitoring of its safety and efficacy.
Eli Lilly and Incyte announced that the FDA granted an Emergency Use Authorization (EUA) for baricitinib in combination with remdesivir for hospitalized patients with COVID-19 requiring supplemental oxygen. This is the second Lilly therapy to receive EUA for COVID-19 treatments. In clinical trials, the combination showed a 12.5% reduction in recovery time and a 35% decrease in mortality compared to remdesivir alone. Despite this progress, the use remains temporary, pending further evaluation of baricitinib's efficacy and safety.
Eli Lilly and Ypsomed have entered a global agreement to develop an automated insulin delivery system. Lilly will commercialize a version of Ypsomed's mylife™ YpsoPump®, already marketed in Europe since 2016. This system will also incorporate continuous glucose monitoring and utilize pre-filled cartridges for Lilly's rapid-acting insulins. Ypsomed aims for FDA clearance in 2022. With diabetes affecting over 34 million Americans, this partnership seeks to enhance diabetes management options.
The EMPA-REG OUTCOME trial results reveal that Jardiance (empagliflozin) significantly reduces the risk of total cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Compared to placebo, Jardiance decreased the relative risk of 3P-MACE by 22%, heart failure hospitalizations by 42%, and all-cause hospitalizations by 17%. These findings underscore the long-term cardiovascular benefits of Jardiance and the ongoing commitment of Boehringer Ingelheim and Eli Lilly to enhance health outcomes in this patient population.
Eli Lilly and Company (NYSE: LLY) is set to participate in the Wolfe Research Virtual Healthcare Conference on November 18, 2020. Joshua Smiley, the company's CFO, will engage in a virtual fireside chat at 1:30 p.m. ET. Investors and interested parties can access a live audio webcast through the Webcasts & Presentations section of Lilly's Investor website, with a replay available for 90 days following the event.
Lilly aims to enhance global healthcare through innovative medicines and community engagement.
Eli Lilly and Company (NYSE: LLY) will join the Bernstein Operational Decisions Conference on November 16, 2020. Key executives, including Andrew Adams and Jeff Emmick, will engage in a virtual fireside chat at 11:00 a.m. ET. A live audio webcast can be accessed via Lilly's Investor website, with a replay available for 90 days. Lilly is committed to advancing healthcare by developing innovative medicines and enhancing disease management. For more details, visit www.lilly.com.
Eli Lilly and Company (NYSE: LLY) will host a webcast on November 20, 2020, at 11:00 a.m. EST, to discuss the Phase 3 clinical trial program for tirzepatide, aimed at treating type 2 diabetes. The session will cover trial designs and the expected schedule for multiple top-line data disclosures. Investors, media, and the public can access the webcast via Lilly's investor website, with a replay available afterwards. The announcement emphasizes Lilly's ongoing commitment to developing effective treatments, while recognizing the uncertainties involved in pharmaceutical research.