Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study for Kisunla (donanemab) in early symptomatic Alzheimer's disease. A modified titration dosing regimen, which shifted one vial from the first infusion to the third infusion, reduced ARIA-E incidence to 14% compared to 24% with standard dosing. The reduction was most significant in APOE4 homozygotes, dropping from 57% to 19%. The modified regimen maintained comparable amyloid plaque reduction (67% vs 69%) and P-tau217 levels. Lilly plans to submit this data to regulators for a potential label update.

Eli Lilly (NYSE: LLY) has announced its quarterly dividend payment for Q4 2024. The company's board of directors has declared a dividend of $1.30 per share on outstanding common stock. The dividend will be paid on December 10, 2024, to shareholders who are on record as of November 15, 2024.

Eli Lilly announced breakthrough results from two Phase 3 studies demonstrating the long-term effectiveness of mirikizumab in treating inflammatory bowel diseases. The drug showed remarkable success in maintaining remission for patients with ulcerative colitis and Crohn's disease.

After three years, over 80% of ulcerative colitis patients maintained remission and symptom relief. For Crohn's disease patients, more than 50% sustained endoscopic remission for up to five years. Mirikizumab, the first IL23p19 antagonist to report such long-term data, demonstrated a consistent safety profile across both conditions.

The drug is already FDA-approved for ulcerative colitis treatment and is under review for Crohn's disease. These findings were presented at the American College of Gastroenterology Annual Meeting 2024.

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.