Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Company (NYSE: LLY) reported that patients with moderately to severely active ulcerative colitis achieved symptomatic remission for up to two years in a Phase 2 study of mirikizumab. Notably, 75.6% of patients maintained remission at 104 weeks. The study observed that 85.9% of participants achieved rectal bleeding remission, and 84.6% reached stool frequency remission. The safety profile of mirikizumab remained consistent with previously published data, and no new safety signals were noted. Results will be presented at UEG Week from October 3-5, 2021.

Eli Lilly and Incyte announced significant results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) for OLUMIANT (baricitinib) in treating severe alopecia areata. The once-daily 4-mg dose demonstrated superior scalp hair regrowth compared to placebo, with 35.2% of patients achieving over 80% scalp coverage at 36 weeks. The 2-mg dose also showed notable improvements. OLUMIANT has received Breakthrough Therapy designation from the FDA, and a supplemental New Drug Application is planned. The drug has an established safety profile with manageable side effects, underscoring its potential in addressing this unmet medical need.

Eli Lilly's tirzepatide showed superior efficacy in reducing liver fat and abdominal adipose tissue compared to insulin degludec in adults with type 2 diabetes, according to findings from the SURPASS-3 MRI sub-study presented at the EASD Annual Meeting. The study, involving 296 participants, demonstrated significant reductions in liver fat content (LFC) with tirzepatide doses (up to -8.09%) against insulin degludec (-3.38%). Additionally, a larger percentage of tirzepatide participants achieved at least a 30% reduction in LFC (up to 81.4%) versus insulin degludec (32.12%). Gastrointestinal side effects were common but diminished with continued use.

Eli Lilly's tirzepatide showed superior performance in glycemic control compared to insulin degludec in a sub-study of the SURPASS-3 clinical trial. The results presented at the EASD meeting indicate participants on tirzepatide 15 mg spent 91.2% of the time within a target glucose range (71-180 mg/dL) over 52 weeks. Additionally, they spent significantly less time in hypoglycemia and exhibited reduced glycemic variability. Overall, tirzepatide's efficacy aligns with its profile as a novel treatment for type 2 diabetes, pending regulatory approvals.

Eli Lilly and Company (NYSE: LLY) has partnered with Susan G. Komen to tackle breast cancer health disparities among Black women in the U.S. This multiyear initiative aims to expand resources and support, providing culturally competent patient navigators, psychosocial support, and educational resources. The program will initially focus on Chicago, St. Louis, and Indianapolis, addressing barriers to early diagnosis and treatment. Black women are 40% more likely to succumb to breast cancer than their white counterparts due to systemic inequities. The collaboration highlights a commitment to health equity in breast cancer care.

Eli Lilly announced FDA approval for ERBITUX (cetuximab) in combination with BRAFTOVI (encorafenib) for treating adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. This new indication is based on the BEACON CRC trial, showing improved overall survival (8.4 months vs. 5.4 months) and a notable objective response rate of 20%. ERBITUX, now with seven FDA approvals for CRC, represents a significant advancement for patients with worse prognoses. However, it does come with common adverse reactions, including fatigue and nausea.

Eli Lilly will reduce the list price of Insulin Lispro Injection by 40% starting January 1, 2022, bringing it to $82.41 for vials and $159.12 for a pack of five pens. This new pricing aligns with 2008 levels and aims to lower out-of-pocket costs for those uninsured or underinsured. The average monthly out-of-pocket cost for Lilly insulin has dropped to $28.05, a 27% decrease since 2017. Lilly encourages individuals to utilize its affordability programs to help manage costs as insulin accessibility becomes a growing health concern.

Eli Lilly and Company (NYSE: LLY) announced that new data from its monarchE study will be presented at the European Society for Medical Oncology (ESMO) Virtual Plenary on October 14, 2021. The study focuses on the investigational use of Verzenio (abemaciclib) combined with endocrine therapy for patients with HR+, HER2- high-risk early breast cancer. In total, 5,637 patients were randomized to receive either Verzenio with standard endocrine therapy or standard endocrine therapy alone, aiming to evaluate invasive disease-free survival and other key outcomes.

Eli Lilly (NYSE: LLY) is recalling lot D239382D of its Glucagon Emergency Kit due to a complaint that the vial contained liquid instead of the intended powder form. This issue may lead to decreased effectiveness in treating severe hypoglycemia, posing serious health risks including seizures. The recall was initiated after a patient experienced a lack of drug effect and subsequent seizures. Distribution of the affected lot has been ceased, and return and replacement measures are underway for consumers and wholesalers.