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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 presented promising results regarding donanemab at the Alzheimer's Association International Conference 2021. The Phase 2 TRAILBLAZER-ALZ study highlighted that greater amyloid plaque clearance was associated with reduced cognitive decline in Alzheimer's patients. Notably, significant biomarker changes were observed within 12 weeks. Donanemab, an investigational antibody, received FDA Breakthrough Therapy designation in June 2021 and aims to slow Alzheimer's progression. Lilly plans to submit a biologics license application later this year.
Eli Lilly and Company (NYSE: LLY) and Incyte announced the FDA has expanded the Emergency Use Authorization (EUA) for baricitinib to treat hospitalized COVID-19 patients. The treatment can now be used alone or with remdesivir for patients requiring supplemental oxygen, mechanical ventilation, or ECMO. The decision follows data from the Phase 3 COV-BARRIER study, demonstrating baricitinib reduced the risk of death by 39%. However, baricitinib has not been formally approved for COVID-19 treatment, and ongoing clinical evaluations continue to assess its efficacy and safety.
Eli Lilly (NYSE: LLY) and Kumquat Biosciences announced a multi-year collaboration to develop novel small molecules aimed at enhancing tumor-specific immune responses. Kumquat will leverage its immuno-oncology platform while retaining rights for product development in Greater China. The deal involves an upfront payment of $70 million, with potential milestone payments exceeding $2 billion. This collaboration aims to expedite the development of innovative cancer therapies, although Lilly's guidance for 2021 earnings per share remains unchanged.
Eli Lilly and Company (NYSE: LLY) is set to announce its second-quarter 2021 financial results on August 3, 2021. A conference call with investors and media will follow at 9 a.m. Eastern time to provide further insights on the company’s performance. Interested parties can access a live webcast via the company’s website, and a replay will be available afterward. Lilly continues to emphasize its commitment to improving healthcare through innovative medicines.
Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the FDA will miss the action date for the supplemental new drug application (sNDA) for baricitinib, intended for moderate to severe atopic dermatitis treatment. The delay is due to the ongoing evaluation of JAK inhibitors by the FDA. Despite this, Lilly expresses confidence in baricitinib’s efficacy and safety and remains committed to bringing it to market. The FDA's decision does not alter Lilly's financial guidance for 2021.
Eli Lilly and Company (NYSE: LLY) has announced a strategic partnership with Banner Alzheimer's Institute to conduct a Phase 3 clinical trial, TRAILBLAZER-ALZ 3, evaluating the investigational antibody donanemab's effectiveness in slowing Alzheimer's disease progression in at-risk participants. The collaboration aims to enhance trial enrollment through innovative methods, leveraging Banner's expertise. Donanemab targets modified beta amyloid and has shown promising results in previous studies. Enrollment for the trial is set to begin later this year, addressing a critical unmet need in Alzheimer's prevention.
Eli Lilly and Company (NYSE: LLY) has acquired Protomer Technologies for over $1 billion, contingent on future milestones. Protomer specializes in protein engineering for glucose-responsive insulin therapies. Previously, Lilly held a 14% stake in Protomer and aims to enhance its diabetes treatment pipeline. The acquisition is expected to bolster innovation in insulin therapy, potentially improving patient outcomes. The deal will not affect Lilly's 2021 non-GAAP earnings per share guidance. Financial and legal advisors include Aquilo Partners, L.P., Morrison & Foerster LLP, and Kirkland & Ellis LLP.
Eli Lilly and Company (NYSE: LLY) reported promising Phase 2 data for mirikizumab, a treatment for ulcerative colitis (UC), indicating gene expression changes sustained for up to one year post-treatment. Mirikizumab showcased unique transcript changes compared to placebo, correlating with mucosal healing. Additionally, a patient study highlighted bowel urgency improvements, crucial for quality of life. With Phase 3 trials underway for both UC and Crohn's disease, mirikizumab's ongoing development appears to target significant unmet needs in inflammatory bowel disease management.
The EMPEROR-Preserved phase III trial confirmed that Jardiance® (empagliflozin) is the first treatment to significantly reduce the risk of cardiovascular death or hospitalization for heart failure in adults with preserved ejection fraction (HFpEF). Announced on July 6, 2021, by Boehringer Ingelheim and Eli Lilly (NYSE: LLY), the trial's results will be presented at the ESC 2021 congress. Jardiance's efficacy in treating all forms of heart failure was reinforced by previous EMPEROR-Reduced trial results. Regulatory submissions are anticipated in 2021, aiming to address the unmet medical needs in heart failure management.
The board of directors of Eli Lilly and Company (NYSE: LLY) has announced a third-quarter 2021 dividend of $0.85 per share for common stockholders. This dividend will be paid on September 10, 2021, to shareholders recorded by the close of business on August 13, 2021. Lilly remains committed to delivering high-quality medicines and addressing real-world health needs as a leading global healthcare company.