Lilly Eli & Co Stock Price, News & Analysis

The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt) for the treatment of early symptomatic Alzheimer's disease (AD) in adults. This makes Japan the second major market to approve Kisunla, following its approval in the United States in July 2024. The treatment is designed for individuals with mild cognitive impairment and mild dementia stage of AD, with confirmed amyloid pathology.

Kisunla demonstrated significant results in the TRAILBLAZER-ALZ 2 Phase 3 study, showing a 35% slowing of decline in less advanced cases and 22% in the overall population. The drug reduced amyloid plaques by up to 84% after 18 months of treatment. Notably, 66% of patients achieved plaque clearance at one year, allowing them to complete treatment.

While Kisunla offers promising results, it can cause side effects such as amyloid-related imaging abnormalities (ARIA) and allergic reactions. The approval of Kisunla in Japan represents a critical step in providing treatment options for the growing number of AD patients in the country.

Eli Lilly's EBGLYSS™ (lebrikizumab-lbkz) has received FDA approval for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older. This IL-13 inhibitor offers a new first-line biologic treatment for patients not well controlled with topical therapies. Key highlights:

- Significant skin clearance as early as 4 weeks and itch relief as early as 2 weeks
- Long-lasting efficacy through one year with monthly maintenance dosing
- 38% achieved clear/almost-clear skin at 16 weeks vs 12% with placebo
- 43% experienced itch relief at 16 weeks vs 12% with placebo
- Common side effects include eye inflammation and injection site reactions

EBGLYSS will be available in the U.S. in the coming weeks, with patient support programs planned.

Eli Lilly and Company (NYSE: LLY) announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, dedicated to producing biologic active ingredients for Alzheimer's treatments. Additionally, Lilly unveiled a new $800 million facility in Kinsale, Ireland, operational since last year to meet the high demand for diabetes and obesity medications. This expansion is part of a larger $20 billion investment plan initiated since 2020.

The Limerick site will employ 450 highly skilled workers and utilize advanced technologies such as AI and machine learning. Production is expected to start in 2026, pending planning approval. The Kinsale facility integrates continuous manufacturing technology and recently won the 'Facility of the Year' Innovation award.

Lilly emphasizes sustainability, with the Limerick site designed to reduce energy, water, and waste, and the Kinsale site powered by the largest privately owned solar farm in Ireland.

Eli Lilly and Company (NYSE: LLY) announced detailed results from the QWINT-5 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 1 diabetes. The study met its primary endpoint of non-inferior A1C reduction at week 26, with efsitora reducing A1C by 0.53% compared to 0.59% for insulin degludec. Key secondary endpoints showed similar time in range and rates of nocturnal hypoglycemic events between the two treatments.

However, efsitora showed higher rates of severe hypoglycemic events (0.14 vs 0.04 per patient-year) compared to insulin degludec, with 64% of these events occurring in the first 12 weeks of treatment. The results highlight the potential of efsitora to offer a once-weekly basal insulin option for type 1 diabetes patients, while also emphasizing the need for careful management of hypoglycemia risk.

Eli Lilly and Company (NYSE: LLY) has announced promising results from the QWINT-2 phase 3 trial of once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes. The study, published in The New England Journal of Medicine and presented at EASD 2024, showed that efsitora met its primary endpoint of non-inferior A1C reduction. Key findings include:

- Efsitora reduced A1C by 1.34% vs. 1.26% for insulin degludec
- Participants achieved 45 minutes more time in range per day with efsitora
- No severe hypoglycemic events were reported with efsitora
- Efsitora demonstrated a safety profile similar to daily insulins

These results suggest efsitora could offer a convenient once-weekly option for type 2 diabetes patients, potentially improving treatment adherence while providing comparable outcomes to daily insulins.

Eli Lilly and Company (NYSE: LLY) has appointed Lucas Montarce as executive vice president and chief financial officer (CFO), effective immediately. Montarce, who joined Lilly in 2001, has held various finance leadership roles within the company, including group vice president, corporate controller, and CFO of Lilly Research Laboratories. He most recently served as Lilly president and general manager for the Spain, Portugal and Greece hub.

Montarce holds a bachelor's degree in business accounting from Catholic University (Argentina) and an MBA from the Center for Macroeconomic Studies of Argentina. CEO David A. Ricks expressed confidence in Montarce's abilities, citing his drive, curiosity, and integrity. Montarce stated his commitment to building on Lilly's strong financial foundation and driving continued success as the company expands its global footprint.

Eli Lilly has announced positive topline results from two phase 3 clinical trials, QWINT-1 and QWINT-3, evaluating once weekly insulin efsitora alfa in adults with type 2 diabetes. The trials showed that efsitora was non-inferior to daily basal insulins in reducing A1C levels.

QWINT-1 studied insulin-naïve patients, using a novel fixed-dose regimen with four doses administered via a single-use autoinjector. QWINT-3 focused on patients switching from daily basal insulin. Both trials met their primary endpoints, demonstrating similar A1C reductions to daily insulins glargine and degludec, respectively.

Efsitora showed a comparable safety profile to daily basal insulins, with QWINT-1 reporting approximately 40% lower rates of severe or clinically significant hypoglycemic events compared to insulin glargine.

Eli Lilly and Company (NYSE: LLY) has partnered with EVA Pharma to expand access to baricitinib in 49 low- to middle-income African countries. This collaboration aims to reach an estimated 20,000 people by 2030, aligning with Lilly's 30x30 initiative to improve healthcare access for 30 million people in resource- settings annually by 2030.

EVA Pharma will manufacture and supply baricitinib locally, with sales expected to begin by 2026. This agreement marks Lilly's first voluntary licensing agreement, providing manufacturing know-how to EVA Pharma. The collaboration builds on their existing partnership to expand access to affordable insulin in 56 countries, as announced in 2022.

Eli Lilly (NYSE: LLY) has announced the release of Zepbound® (tirzepatide) 2.5 mg and 5 mg single-dose vials for self-pay patients with obesity. This expansion aims to meet high demand and broaden access to the medication. The vials are priced at least 50% less than other incretin medicines for obesity. Available through LillyDirect®'s self-pay channel, the 2.5 mg four-week supply costs $399, while the 5 mg dose is $549.

Zepbound, which activates both GIP and GLP-1 hormone receptors, achieved an average of 15% weight loss over 72 weeks in clinical trials. The single-dose vials are intended for adults with obesity or overweight individuals with weight-related medical problems. Lilly emphasizes the importance of using Zepbound with a reduced-calorie diet and increased physical activity.