Eli Lilly & Co. - LLY STOCK NEWS

Full results from the EMPEROR-Reduced phase III trial revealed that Jardiance (empagliflozin) significantly reduced cardiovascular death or hospitalization due to heart failure by 25%. The trial, presented at ESC Congress 2020, included adults with heart failure and was compared to a placebo. Key findings showed a 30% reduction in heart failure hospitalizations and a slower decline in kidney function among those taking Jardiance. The FDA has granted Fast Track designation for Jardiance concerning heart failure and chronic kidney disease, emphasizing the urgency for new treatment options.

Eli Lilly announced that the New England Journal of Medicine published Phase 1/2 study results for Retevmo™ (selpercatinib), the first therapy specifically indicated for metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced RET-altered thyroid cancers. The study showed high overall response rates (ORR) of 85% in treatment-naïve and 64% in previously treated NSCLC patients. In RET-mutant medullary thyroid cancer, the ORR was 73%. The data supports Retevmo as a significant treatment option for these patient populations, contingent on further confirmatory trials.

Eli Lilly and Innovent Biologics have expanded their global alliance for TYVYT® (sintilimab injection), an anti-PD-1 monoclonal antibody, to include markets outside of China. Innovent will receive a $200 million upfront payment and potential milestones totaling $825 million. TYVYT is already approved for relapse or refractory classic Hodgkin's lymphoma in China and is undergoing trials for non-small cell lung cancer (NSCLC). Recent data shows TYVYT alongside Alimta and chemotherapy significantly improves progression-free survival in advanced NSCLC. The deal is pending regulatory clearance.

Eli Lilly and Company (NYSE: LLY) has announced the initiation of BLAZE-2, a Phase 3 trial of LY-CoV555 aimed at preventing SARS-CoV-2 infection in long-term care facilities in the U.S. This study will enroll up to 2,400 participants and assess the antibody's efficacy and safety over eight weeks. LY-CoV555 is a neutralizing antibody developed in collaboration with AbCellera, designed to block viral entry. The trial addresses the urgent need for effective therapies in these vulnerable populations significantly affected by COVID-19.

Eli Lilly and Company (LLY) reported its Q2 2020 financial results with $5.499 billion in revenue, a 2% decline from Q2 2019. However, net income rose 6% to $1.412 billion, translating to an EPS of $1.55. Non-GAAP net income saw a significant increase of 24%, reaching $1.721 billion with an EPS of $1.89, up 26%. Key FDA approvals were achieved for multiple products, including Retevmo and Lyumjev. COVID-19 impacted new patient starts and revenue trends, estimated at a $250 million decline. The company anticipates growth in new prescriptions for key products in H2 2020.

On July 30, 2020, Boehringer Ingelheim and Eli Lilly announced positive top-line results from the EMPEROR-Reduced phase III trial, which evaluated Jardiance® (empagliflozin) in adults with heart failure with reduced ejection fraction. The trial demonstrated superiority over placebo in reducing the risk of cardiovascular death or hospitalization due to heart failure. Safety profiles were consistent with prior data. These findings position Jardiance as a potential new standard of care, with full results scheduled for presentation at the ESC Congress on August 29, 2020, and regulatory submissions planned for 2020.

Eli Lilly's study on P-tau217, a blood test for Alzheimer's disease, published in JAMA, demonstrates its superior ability to distinguish Alzheimer's from other neurodegenerative diseases when compared to current biomarkers and imaging methods. The test showed elevated levels in Colombian mutation carriers' blood, indicating Alzheimer's potential onset up to 20 years before symptoms. The findings support earlier diagnosis and better treatment strategies. However, the test is not yet approved and requires further validation. Lilly remains committed to advancing Alzheimer's research and diagnostics.

Eli Lilly and Company (NYSE: LLY) announced new findings from 17 studies to be presented at the virtual Alzheimer's Association International Conference (AAIC) 2020, from July 27-31. The research focuses on developing disease-modifying therapies for Alzheimer's and improving diagnostic methods. The company has emphasized its commitment to Alzheimer's research for over 30 years, highlighting the urgency of addressing this growing health crisis. Specific studies will cover topics such as blood biomarkers and Flortaucipir PET imaging, aiming to enhance diagnosis and treatment in Alzheimer's patients.

Eli Lilly and Company (NYSE: LLY) will announce its second-quarter 2020 financial results on July 30, 2020. A conference call for investors and media will take place at 9 a.m. Eastern time on the same day. Participants can access the live webcast through a link on Lilly's website, with a replay available afterwards. Eli Lilly aims to enhance its global healthcare leadership by creating life-changing medicines and improving disease management.