Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly (NYSE:LLY) has received European Commission marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease. The approval covers adults with mild cognitive impairment and mild dementia stages with confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers.

Kisunla, administered monthly, is the only therapy that supports completing treatment once amyloid plaques reach minimal levels. The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated significant slowing of cognitive and functional decline. The drug helps remove excessive amyloid plaque buildup in the brain, potentially preserving cognitive function and independence longer.

The approval is particularly significant as Alzheimer's affects 6.9 million people in Europe, with numbers expected to double by 2050. The treatment showed effectiveness in reducing disease progression risk over 18 months, with earlier treatment yielding better responses.

Eli Lilly (NYSE:LLY) has received FDA approval for Inluriyo (imlunestrant), an oral estrogen receptor antagonist for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer who progressed after endocrine therapy.

In the Phase 3 EMBER-3 trial, Inluriyo demonstrated significant efficacy by reducing progression or death risk by 38% versus endocrine therapy. The median progression-free survival was 5.5 months compared to 3.8 months for standard treatment. The drug showed a manageable safety profile with mostly Grade 1-2 adverse events.

Inluriyo targets ESR1 mutations, which occur in approximately 50% of patients who have taken hormone therapies. The drug will be available in the U.S. within weeks and is currently being studied in the Phase 3 EMBER-4 trial for early breast cancer treatment.

Eli Lilly (NYSE:LLY) has announced plans to construct a $6.5 billion manufacturing facility in Houston, Texas, marking its eighth U.S. manufacturing site since 2020. The next-generation synthetic medicine facility will focus on producing small molecule medicines, including the company's oral GLP-1 receptor agonist, orforglipron.

The facility will create 615 high-wage jobs and generate 4,000 construction jobs. Expected to be operational within five years, it will be equipped with advanced technologies including AI, machine learning, and digital automation. The Houston site, selected from over 300 applications, represents one of four new U.S. manufacturing sites Lilly plans to announce this year.

Eli Lilly (NYSE:LLY) announced positive Phase 3 trial results for Mounjaro (tirzepatide) in children and adolescents with type 2 diabetes. The SURPASS-PEDS trial demonstrated that Mounjaro achieved superior A1C reduction of 2.2% from baseline compared to placebo at 30 weeks.

Key highlights include 86.1% of participants on 10mg dose achieving target A1C of ≤6.5%, and an average BMI reduction of 11.2%. The safety profile was consistent with adult studies, with mainly mild-to-moderate gastrointestinal side effects. These results have been submitted to global regulatory agencies for an expanded indication.

Eli Lilly (NYSE:LLY) announced positive topline results from ACHIEVE-3, a Phase 3 head-to-head trial comparing its oral GLP-1 drug orforglipron against oral semaglutide in 1,698 adults with type 2 diabetes. The 52-week trial demonstrated orforglipron's superiority, with the highest dose (36mg) achieving a 2.2% A1C reduction versus 1.4% with oral semaglutide's highest dose (14mg).

In key secondary endpoints, orforglipron 36mg showed 73.6% greater relative weight loss, with patients losing an average of 19.7 lbs (9.2%) compared to 11.0 lbs (5.3%) with oral semaglutide 14mg. Notably, 37.1% of participants on the highest orforglipron dose achieved near-normal blood sugar (A1C <5.7%) versus 12.5% for oral semaglutide. Lilly plans to submit orforglipron for regulatory approval in 2026.

Eli Lilly (NYSE:LLY) announced Phase 3 ATTAIN-1 trial results for orforglipron, an investigational oral GLP-1 receptor agonist for obesity treatment. The once-daily pill demonstrated significant weight loss, with participants taking the highest dose (36mg) achieving an average reduction of 27.3 lbs (12.4%) at 72 weeks.

Key findings include: 59.6% of participants on the highest dose lost ≥10% body weight, 39.6% lost ≥15%, and among participants with prediabetes, up to 91% achieved near-normal blood sugar levels compared to 42% on placebo. The drug showed meaningful improvements in cardiovascular risk factors, reducing hsCRP levels by 47.7%.

Safety profile aligned with the GLP-1 class, with primarily gastrointestinal-related adverse events. Lilly plans global regulatory submissions for obesity treatment, with potential approval as early as next year, followed by type 2 diabetes submission in 2026.

Eli Lilly (NYSE:LLY) has announced plans to construct a $5 billion manufacturing facility in Goochland County, Virginia, marking the first of four planned U.S. manufacturing sites to be announced this year. The facility will be the company's first dedicated, fully integrated site for producing active pharmaceutical ingredients (API) and drug products for bioconjugates and monoclonal antibodies.

The project will create 650 high-paying permanent jobs and 1,800 construction jobs, with completion expected within five years. The facility will focus on manufacturing antibody-drug conjugates (ADCs) and is part of Lilly's $50 billion U.S. capital expansion commitment since 2020. For every dollar invested, the company expects to generate up to four dollars in local economic activity.

Eli Lilly (NYSE:LLY) announced its participation in Bernstein's 2nd Annual Healthcare Forum on September 25, 2025. The company's CFO, Lucas Montarce, will participate in a fireside chat at 8:00 AM ET.

Investors can access a live audio webcast through Lilly's investor website, with a replay available for approximately 90 days following the event.

Eli Lilly (NYSE:LLY) has launched "Brain Health Matters," a global campaign aimed at promoting proactive brain health and early detection of Alzheimer's disease. The company has partnered with acclaimed actress Julianne Moore to raise awareness, particularly among women who represent nearly two-thirds of Alzheimer's diagnoses.

The multi-year campaign builds on 35 years of brain health research and comes as statistics show that 13.8 million people aged 65 and older are projected to have Alzheimer's dementia by 2060. The initiative emphasizes early intervention, noting that Alzheimer's can begin up to 20 years before symptoms appear. The campaign will run across U.S. television, digital, and audio platforms, with plans for global expansion.