Welcome to our dedicated page for Lilly Eli & Co news (Ticker: LLY), a resource for investors and traders seeking the latest updates and insights on Lilly Eli & Co stock.
Eli Lilly and Company (NYSE: LLY) generates frequent news across cardiometabolic health, oncology, immunology, obesity and manufacturing expansion. This page aggregates recent press releases and third-party coverage so readers can follow how Lilly’s medicines, clinical programs and corporate actions are evolving over time.
Recent updates show Lilly reporting Phase 3 results for multiple late-stage assets. In obesity and cardiometabolic health, the company has shared topline data from ATTAIN-MAINTAIN, a Phase 3 trial of orforglipron, an investigational once-daily oral GLP-1 receptor agonist, for weight maintenance after prior treatment with injectable incretin therapies. Lilly has also reported results from TRIUMPH-4, a Phase 3 trial of retatrutide, an investigational triple agonist targeting GIP, GLP-1 and glucagon receptors, in adults with obesity or overweight and knee osteoarthritis, with co-primary endpoints in weight loss and pain reduction.
In immunology, Lilly has announced positive topline results from the TOGETHER-PsA Phase 3b trial, which evaluated concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) versus Taltz alone in adults with active psoriatic arthritis and obesity or overweight with at least one weight-related condition. The company reports that the combination met the primary endpoint and all key secondary endpoints, supporting an integrated approach to treating psoriatic arthritis and obesity.
Oncology news includes updated EMBER-3 data for Inluriyo (imlunestrant) as monotherapy and in combination with Verzenio (abemaciclib) in ER-positive, HER2-negative advanced breast cancer, and Phase 3 BRUIN CLL-313 results showing that Jaypirca (pirtobrutinib) significantly reduced the risk of progression or death versus chemoimmunotherapy in treatment-naïve CLL/SLL without 17p deletions.
Corporate and strategic news items cover Lilly’s planned acquisition of Ventyx Biosciences, completion of the Adverum Biotechnologies tender offer, a strategic collaboration with Aktis Oncology, and a major manufacturing investment in a new active pharmaceutical ingredient facility in Huntsville, Alabama. Investors and observers can use this news feed to monitor clinical milestones, regulatory submissions, acquisitions, collaborations, financing activities and manufacturing expansions related to LLY.
Eli Lilly and Incyte announced that in a sub-study of the COV-BARRIER trial, the use of baricitinib in critically ill COVID-19 patients on mechanical ventilation showed a 46% reduction in 28-day mortality compared to placebo. Specifically, the mortality rate was 39.2% for baricitinib versus 58% for placebo. No new safety issues were reported, and adverse event rates were comparable between groups. The FDA has broadened the Emergency Use Authorization for baricitinib for treating COVID-19 in hospitalized adults and pediatric patients requiring respiratory support.
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.