Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly and Company (NYSE: LLY) announced leadership changes effective October 1, 2020. Patrik Jonsson has been appointed as senior vice president, president of Lilly USA, and Chief Customer Officer. He succeeds Ilya Yuffa, who is promoted to senior vice president and president of Lilly Bio-Medicines. Both leaders will report to CEO David A. Ricks. Jonsson's extensive experience in managing complex markets and Yuffa's leadership in U.S. Diabetes are expected to benefit the company as it prepares for new medicine launches.

The FDA has approved two new doses of Trulicity (dulaglutide) by Eli Lilly (NYSE: LLY), expanding its offerings to 3.0 mg and 4.5 mg. This decision follows positive results from the phase 3 AWARD-11 trial, which indicated significant reductions in A1C and body weight for patients with type 2 diabetes. The 4.5 mg dose achieved A1C reduction of -1.9% and weight loss of -10.4 pounds, while the 3.0 mg dose showed reductions of -1.7% in A1C and -8.8 pounds in weight. These new doses are expected in U.S. pharmacies by late September.

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.