Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Incyte announced that the European Medicines Agency's CHMP has issued a positive opinion for baricitinib (OLUMIANT®) to treat moderate to severe atopic dermatitis (AD) in adults. This marks a significant step towards regulatory approval in Europe, potentially making it the first JAK inhibitor approved for AD. The opinion is based on the Phase 3 BREEZE-AD clinical trials which demonstrated efficacy and safety. A final decision from the European Commission is expected within two months, highlighting the urgency for more treatment options for patients suffering from AD.

Eli Lilly and Incyte announced that their clinical trial ACTT-2 met its primary endpoint, demonstrating a reduction in recovery time for COVID-19 patients treated with baricitinib in combination with remdesivir. The median recovery time was reduced by approximately one day, showing statistical significance. Lilly plans to seek emergency use authorization from regulatory bodies for baricitinib. Ongoing analyses will explore further clinical outcomes, and Lilly is committed to maintaining supply for RA patients while evaluating additional studies on baricitinib's efficacy in COVID-19 treatment.

Eli Lilly announced promising results from the interim analysis of the BLAZE-1 clinical trial for LY-CoV555, a monoclonal antibody targeting COVID-19. The trial revealed a significant 72% decrease in hospitalization rates for patients treated with LY-CoV555 compared to placebo. The primary endpoint of viral load reduction was achieved at a dose of 2800 mg. Additionally, the treatment was well tolerated, with no serious adverse events reported. Ongoing studies will further assess its effectiveness in high-risk populations.

Eli Lilly announced interim results from the BLAZE-1 clinical trial, indicating that its neutralizing antibody, LY-CoV555, significantly reduced COVID-19 related hospitalizations. Patients receiving LY-CoV555 had a 72% lower risk of hospitalization compared to placebo. The primary endpoint of viral load reduction was met at the 2800 mg dosage. The treatment was well-tolerated with no serious adverse events. Ongoing studies will further evaluate LY-CoV555's efficacy and safety in higher-risk populations.

Eli Lilly has announced a new open innovation challenge aimed at enhancing care for individuals with atopic dermatitis. The challenge invites submissions for digital health solutions that improve quality of life for patients dealing with this chronic skin condition. Entries will be accepted until October 21, 2020, with five finalists selected by November 20, 2020. The winning submission will receive a $50,000 award and a potential collaboration opportunity with Lilly. This initiative aligns with Lilly's commitment to leveraging technology for better health outcomes.

The FDA has granted Fast Track designation to Jardiance (empagliflozin) for preventing hospitalization and mortality in patients post-heart attack. Approximately 1.5 million heart attacks annually contribute significantly to heart failure risks. The EMPACT-MI trial aims to evaluate Jardiance's effectiveness in improving survival rates. Jardiance is already approved for lowering blood sugar in type 2 diabetes patients and reducing cardiovascular death risk. Results from the EMPACT-MI trial are anticipated in 2023, marking a critical advance in patient care.

Eli Lilly and Incyte announced promising results from the Adaptive COVID-19 Treatment Trial (ACTT-2), which involved over 1,000 hospitalized patients. The trial assessed the efficacy of baricitinib combined with remdesivir, showing a significant reduction of approximately one day in median recovery time compared to remdesivir alone. This finding is statistically significant and meets the primary endpoint of the study. Lilly intends to seek emergency use authorization for the 4-mg dose of baricitinib for COVID-19 treatment, while also continuing trials to understand its full potential.

Innovent Biologics and Eli Lilly announced the presentation of six clinical studies on TYVYT® (sintilimab injection) at the ESMO Virtual Congress 2020 from September 19-21. The studies cover various cancers, including lung, gynecological, hepatocellular, and gastric cancers. Significant findings include the ORIENT-11 and ORIENT-12 studies demonstrating the efficacy of sintilimab in combination therapies for advanced lung cancer. These presentations aim to enhance understanding of the drug's efficacy and guide future treatments.

Innovent and Eli Lilly announce the presentation of six clinical studies for TYVYT® (sintilimab injection) at the upcoming ESMO Virtual Congress 2020 from September 19-21. Key studies include Phase 3 trials for lung cancer and hepatocellular carcinoma, showing positive preliminary efficacy. Innovations include the combination of sintilimab with various chemotherapy agents, providing insights into patient selection and treatment outcomes. The collaboration between Innovent and Lilly emphasizes a strong partnership in advancing oncology treatments.