Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly's EBGLYSS (lebrikizumab-lbkz) demonstrated significant efficacy in treating moderate-to-severe atopic dermatitis patients who previously discontinued dupilumab. In the Phase 3b ADapt study, 57% of patients achieved EASI-75 at Week 16, and 60% at Week 24. The treatment showed particular effectiveness in difficult-to-treat areas, with 52% of patients achieving clear or almost clear face dermatitis at Week 24. The drug's safety profile remained consistent with previous studies, with less than 6% of patients discontinuing due to adverse events. EBGLYSS, recently approved by the FDA, is administered as a monthly maintenance injection following an initial treatment phase.

Eli Lilly's Kisunla™ (donanemab) has received marketing authorization in Great Britain for treating mild cognitive impairment and mild dementia due to Alzheimer's disease in specific adult patients. The approval is to apolipoprotein E ε4 heterozygotes or non-carriers. This marks Great Britain as the third major market to approve donanemab, following approvals in the United States (July 2024) and Japan (September 2024). The drug, administered via intravenous infusion every four weeks, is unique as the only amyloid plaque-targeting therapy with evidence supporting treatment discontinuation after plaque removal. In the UK, where an estimated 982,000 people live with dementia, the total cost of dementia care is projected at £42 billion in 2024.

Eli Lilly and Company (NYSE: LLY) has announced that it will release its third-quarter 2024 financial results on October 30, 2024. The company will also host a conference call at 10 a.m. Eastern time on the same day to discuss the financial performance with investors, media, and the general public.

A live webcast of the conference call will be accessible through a link on Lilly's investor relations website. For those unable to attend the live event, a replay will be available on the same website following the conference call.

Eli Lilly and Company released results from their national 'Urgent Conversations' survey, highlighting the challenges faced by people with ulcerative colitis (UC) in finding public restrooms. The survey of 1,800 U.S. adults, including 200 with moderately to severely active UC, found that 84% of UC patients struggle to find public restrooms, compared to 60% of the general population.

Key findings include:

• 63% of UC respondents need to use restrooms frequently when leaving home
• 81% of UC respondents take over 5 minutes to find a clean restroom
• 42% of UC respondents are more likely to have restroom emergencies
• 61% of UC respondents limit social outings due to restroom concerns

The Crohn's & Colitis Foundation has launched the 'We Can't Wait' mobile app to help locate public restrooms. Lilly's Omvoh® (mirikizumab-mrkz), approved in October 2023, showed promising results in treating UC symptoms and improving bowel urgency in clinical trials.

Eli Lilly and Company (NYSE: LLY) announced new data from the VIVID-1 Phase 3 study of mirikizumab for Crohn's disease. The study showed that more patients treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. This is the first Phase 3 study to report histologic and combined histologic-endoscopic outcomes in Crohn's disease using a systematic assessment of five bowel segments.

Key findings include:

• 58.2% of mirikizumab patients achieved histologic response at Week 52 vs 48.8% for ustekinumab (p=0.0075)
• In patients with prior biologic failure, 56.5% on mirikizumab achieved histologic response at Week 52 vs 41.3% for ustekinumab (p=0.0064)
• Mirikizumab's safety profile was consistent with its known profile in ulcerative colitis

Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease globally and is conducting additional studies in pediatric and adult patients.

Eli Lilly and Company (NYSE: LLY) has announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Indiana's LEAP Research and Innovation District. This unique facility, set to open in late 2027, will combine research and manufacturing in a single location, allowing Lilly to innovate new production methods and scale up manufacturing of medicines for clinical trials.

The Medicine Foundry will focus on developing innovative solutions to optimize manufacturing processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact. It will be capable of producing various molecular therapies, including small molecules, biologics, and nucleic acid therapies. The facility is expected to add 400 full-time jobs for highly skilled workers and will expand Lilly's total capital commitment in the United States to more than $23 billion since 2020.

Eli Lilly and Company (NYSE: LLY) announced new long-term results for EBGLYSS™ (lebrikizumab-lbkz) in treating moderate-to-severe atopic dermatitis. The data, from the ADjoin long-term extension study, will be presented at the European Academy of Dermatology and Venereology Congress.

Key findings include:

• Over 80% of adults and adolescents who responded to EBGLYSS at Week 16 maintained clear or almost-clear skin for up to three years with monthly maintenance dosing.
• 84% of patients on monthly dosing and 83% on bi-weekly dosing maintained clear or almost-clear skin (IGA 0,1) at three years.
• 87% of monthly dosing patients and 79% of bi-weekly dosing patients achieved or maintained at least 90% improvement in disease extent and severity (EASI-90) at three years.
• The safety profile remained consistent with previous studies, with no new safety signals observed.

EBGLYSS, an IL-13 inhibitor, was recently approved by the FDA and is also approved in the EU and Japan.

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.