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.
The FDA has granted Emergency Use Authorization (EUA) to Eli Lilly's investigational neutralizing antibody, bamlanivimab (LY-CoV555) 700 mg, for treating mild to moderate COVID-19 in patients aged 12 and older who are at high risk of severe illness. Administered via a single intravenous infusion, bamlanivimab is designed to be given within 10 days of symptom onset. This authorization is based on data from the BLAZE-1 clinical trial, which showed significant reduction in viral load and related hospitalizations. The U.S. government has purchased 300,000 doses to ensure accessibility.
Loxo Oncology at Lilly announced the presentation of data on LOXO-305, an investigational BTK inhibitor, at the ASH Annual Meeting from December 5-8, 2020. Updated clinical data from the Phase 1/2 BRUIN trial will be shared, focusing on previously treated chronic lymphocytic leukemia and other non-Hodgkin lymphomas. Presentations will include a Phase 1/2 study's results and pre-clinical evaluations combining LOXO-305 with other therapies. The trial aims to assess LOXO-305's safety, efficacy, and recommended dosages.
Eli Lilly and Company (NYSE: LLY) announced the retirement of Aarti Shah, Ph.D., senior vice president and chief information and digital officer, in the first half of 2021 after 27 years of service. A search for her successor is underway. CEO David A. Ricks praised Shah's contributions, highlighting her leadership in connecting IT with drug development, manufacturing, and commercial capabilities. Shah's tenure included roles in biometrics and brand development. The company acknowledges potential risks related to leadership changes and the challenge of finding her successor.
On November 2, 2020, Eli Lilly and Incyte announced positive long-term data for Olumiant (baricitinib) to be presented at ACR Convergence 2020. Key findings show that 27.5% of csDMARD-IR and 18.4% of bDMARD-IR patients achieved Low Disease Activity after 2.3 years. In a 5-year study, low rates of radiographic progression were maintained across various RA patient populations. No new safety concerns were identified, reinforcing Olumiant's long-term efficacy and safety for moderate to severe rheumatoid arthritis treatments.
Eli Lilly and Incyte announced new data for baricitinib presented at the 29th annual EADV Congress, showcasing its long-term efficacy in treating moderate to severe atopic dermatitis. In the BREEZE-AD3 Phase 3 study, over 40% of patients maintained clear skin after 68 weeks of treatment. Baricitinib received EU approval for adult patients who qualify for systemic therapy. The safety profile aligns with previous studies, reinforcing its potential role in managing this chronic condition ultimately impacting approximately 1-3% of adults worldwide.
Eli Lilly and Incyte presented data for baricitinib at the virtual Fall Clinical Dermatology meeting from Oct 29 to Nov 1, 2020. The Phase 2 study (BRAVE-AA1) evaluated its efficacy in adult patients with alopecia areata (AA). Results showed significant improvement in patients achieving a SALT score ≤20 at 36 weeks, with the 4-mg dose showing 51.9% improvement versus 3.6% for placebo (p=0.001). Following positive Phase 2 results, Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) have been initiated. The FDA has granted Breakthrough Therapy designation for baricitinib for AA due to unmet medical needs.
Eli Lilly and Company (NYSE: LLY) announced new data on Taltz (ixekizumab) at the European Academy of Dermatology and Venereology Congress. The findings from the long-term UNCOVER-3 study show five-year sustained efficacy of Taltz for psoriasis, with 83%, 73%, and 89% of patients achieving complete clearance in challenging areas like the scalp, nails, and palms. No new safety concerns were reported. Additional results highlighted Taltz's effectiveness in treating psoriatic arthritis, showcasing a significant patient response rate compared to adalimumab.
Eli Lilly announced the publication of Phase 2 BLAZE-1 study data for bamlanivimab (LY-CoV555) in the New England Journal of Medicine. The study assessed the efficacy of bamlanivimab in outpatient COVID-19 patients with mild to moderate symptoms. Results indicated that bamlanivimab may effectively reduce viral load and hospitalization risks. The company is pursuing emergency use authorization from the FDA for this treatment. The trial enrolled over 800 participants and reported no serious drug-related adverse events, supporting its potential role in early-stage COVID-19 treatment.
Eli Lilly announced an agreement with the U.S. government to supply 300,000 vials of bamlanivimab, an investigational antibody, for $375 million, pending Emergency Use Authorization (EUA) from the FDA. The initial agreement includes provisions for an additional 650,000 vials. Lilly aims to manufacture up to one million doses by the end of 2020, with significant production capacity expected in Q1 2021. The company has completed Phase 1 studies showing potential benefits of bamlanivimab in treating COVID-19. The government program ensures no out-of-pocket cost for patients receiving the treatment.
Eli Lilly announced Q3 2020 results, reporting revenue of $5.741 billion, a 5% increase from Q3 2019. Net income was $1.208 billion (-4%), with EPS of $1.33 (-3%). Non-GAAP net income grew by 3% to $1.407 billion, with EPS at $1.54 (+4%). Key growth products contributed significantly, with notable increases in Trulicity (+9%) and Taltz (+34%). Total operating expenses rose 9% to $3.035 billion, impacted by COVID-19 expenses of $125 million. Lilly also made strides in COVID-19 treatment development, submitting a request for Emergency Use Authorization for bamlanivimab.