Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly and Company (NYSE: LLY) has partnered with the Bill & Melinda Gates Foundation to improve access to its COVID-19 therapeutic antibodies in low- and middle-income countries. The initiative, part of the COVID-19 Therapeutics Accelerator, aims to facilitate the distribution of these treatments around the world. Manufacturing is set to begin in April 2021, with some volumes available earlier, pending regulatory approval. Collaborators of Lilly have waived their royalties for these therapies in the targeted regions, reinforcing the commitment to equitable healthcare access.

Eli Lilly (NYSE: LLY) provided updates on its SARS-CoV-2 neutralizing antibody programs, sharing interim data from the BLAZE-1 trial. The combination therapy of LY-CoV555 and LY-CoV016 showed significant reductions in viral load and COVID-related hospitalizations. Lilly expects to have up to 1 million doses of LY-CoV555 available in Q4 2020. The company is engaging global regulators for potential Emergency Use Authorization (EUA) for the treatments, with a BLA submission expected as early as Q2 2021. The combination therapy demonstrated a relative risk reduction of 84.5% in hospitalizations.

On October 6, 2020, Eli Lilly announced results from the Phase 3 CENTURION study, indicating that adults taking REYVOW® (lasmiditan) for migraine experienced significantly higher odds of achieving pain freedom at 2 hours compared to placebo. The 200 mg dose showed 7.2 times greater odds, translating to a 20% therapeutic gain, while the 100 mg dose had 3.8 times greater odds with a 10% gain. The trial involved 1,471 participants and demonstrated consistent efficacy across multiple attacks, making REYVOW a promising option for migraine treatment.

On September 11, 2020, Health Canada approved Trulicity (dulaglutide) for reducing the risk of non-fatal stroke in adults with type 2 diabetes and cardiovascular risk factors. This makes Trulicity the first GLP-1 receptor agonist with such a cardiovascular indication. The approval is based on the REWIND trial, which demonstrated a significant risk reduction in major adverse cardiovascular events. Dr. Hertzel Gerstein highlighted the importance of this new indication in diabetes care, while Dr. Doron Sagman noted it as a milestone in diabetes and cardiovascular management.

Eli Lilly and Company (NYSE: LLY) announced that Verzenio® (abemaciclib) combined with standard adjuvant endocrine therapy reduced breast cancer recurrence risk by 25% in patients with high-risk HR+, HER2- early breast cancer. The study showed 92.2% invasive disease-free survival in the Verzenio arm compared to 88.7% in the control arm after two years. Additionally, it resulted in a 28% decrease in the risk of metastatic disease. The trial involved over 5,600 participants across 38 countries, with results set for regulatory submission by the end of 2020.

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.