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.
Eli Lilly, Vir Biotechnology, and GlaxoSmithKline announced promising topline results from the Phase 2 BLAZE-4 trial, showing that the combination of bamlanivimab and VIR-7831 significantly reduced high viral loads in low-risk COVID-19 patients by 70% at day 7 compared to placebo. No related hospitalizations or deaths occurred by day 29. Preclinical data suggest the combination can combat resistant SARS-CoV-2 variants. An Emergency Use Authorization application for VIR-7831 has been submitted to the FDA, aiming to expedite its availability for COVID-19 treatment.
Eli Lilly announced positive patient-reported outcomes for Verzenio (abemaciclib) combined with standard endocrine therapy for high-risk early breast cancer. In the analysis presented at the 17th St. Gallen Conference, about 70-75% of patients reported minimal side effects. The previous monarchE trial showed a significant 28.7% reduction in breast cancer recurrence with Verzenio. Most patients reported similar quality of life and side effects between treatment arms, except increased diarrhea in those receiving Verzenio. The ongoing trial will continue to assess safety and other outcomes.
Eli Lilly and Company (LLY) announced that mirikizumab achieved primary and all key secondary endpoints in the Phase 3 LUCENT-1 trial for moderate to severe ulcerative colitis, demonstrating significant clinical remission and symptom improvement by Week 12. The study reported statistically significant results (p0.0001) and rapid symptom relief within four weeks. Patient safety profile remained consistent with prior studies. Ongoing maintenance study LUCENT-2 aims to further evaluate mirikizumab's long-term effects. Full results will be disclosed in future publications.
Eli Lilly (NYSE: LLY) presented Phase 2 TRAILBLAZER-ALZ results, confirming that donanemab significantly slows cognitive decline in early Alzheimer's patients. The study demonstrated a 32% decline in the Integrated Alzheimer's Disease Rating Scale compared to placebo at 76 weeks, with notable amyloid plaque clearance. Secondary endpoints showed a 20-40% decline across various cognitive measures. Despite a 26.7% incidence of amyloid-related imaging abnormalities, ongoing discussions with regulators are promising, enhancing donanemab's potential for disease modification.
Eli Lilly and Company (NYSE: LLY) announced participation in the 2021 AACR Annual Meeting with presentations from its oncology portfolio. Highlights include data on Retevmo® (selpercatinib) for RET fusion-positive cancers beyond lung and thyroid cancers. The company will also showcase preclinical data for a selective estrogen receptor degrader, a BCL2 inhibitor, and next-generation KRAS-G12C and RET inhibitors. Retevmo received FDA’s Accelerated Approval last May, and further studies are aimed at expanding its application in various cancer types.
Eli Lilly reports promising results from the BLAZE-1 Phase 3 study, showing that bamlanivimab and etesevimab significantly lower COVID-19 hospitalizations and deaths in high-risk patients. Among 769 participants, the combination treatment led to an 87% reduction in events compared to placebo. No deaths occurred in the treatment group, while 15 occurred in the placebo group. The FDA and EMA support the emergency use of these treatments, emphasizing their potential as a life-saving option against COVID-19, especially with emerging variants.
Eli Lilly (NYSE: LLY) will present new data from ten studies at the virtual AD/PD 2021 conference from March 9-14, 2021. The TRAILBLAZER-ALZ phase 2 study demonstrated that donanemab significantly slowed cognitive decline in early symptomatic Alzheimer's patients compared to placebo. The conference will highlight Lilly's commitment to developing disease-modifying therapies and diagnostics for Alzheimer's disease, which currently affects over 50 million globally. The company aims to enhance early diagnosis and treatment options for this complex illness.
Eli Lilly and Company (NYSE: LLY) announced the retirement of two executive committee members: Myles O'Neill, senior VP of manufacturing operations, effective May 2, 2021, and Melissa Barnes, chief ethics and compliance officer, effective June 27, 2021. Edgardo Hernandez will succeed O'Neill, bringing extensive manufacturing experience, while Alonzo Weems will take over for Barnes, enhancing compliance and risk management. CEO David Ricks highlighted the executives' legacies and the potential growth under the new leadership.
Eli Lilly and Company (NYSE: LLY) has entered a research collaboration with Biolojic Design Ltd. to explore a novel antibody-based therapy for diabetes. The agreement includes research fees and the potential for Biolojic to earn up to $121 million in development milestones. Lilly's approach involves leveraging Biolojic's AI-driven multibody platform, designed to enhance therapeutic precision. Both companies aim to innovate diabetes treatment, with no changes to Lilly's 2021 financial guidance anticipated from this partnership.
Eli Lilly and Company (NYSE: LLY) will participate in the Barclays Global Healthcare Conference on March 9, 2021. Patrik Jonsson, senior vice president and chief customer officer, will engage in a virtual fireside chat at 9:45 a.m. ET. A live audio webcast will be available on Lilly's Investor website, and a replay will be accessible for about 90 days. Lilly is dedicated to creating high-quality medicines and improving disease management globally. For more information, visit www.lilly.com.