Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly (NYSE: LLY) reported positive topline Phase 3 results for oral GLP-1 orforglipron from ACHIEVE-2 and ACHIEVE-5 on Oct 15, 2025. At week 40, orforglipron doses (3 mg, 12 mg, 36 mg) met primary and all key secondary endpoints for both efficacy and treatment-regimen estimands, delivering meaningful A1C reductions and weight loss versus comparators.

Key numeric results: ACHIEVE-2 A1C change vs dapagliflozin (efficacy estimand) was -1.3%/ -1.7%/ -1.7% (3/12/36 mg) vs -0.8%; ACHIEVE-5 with insulin glargine showed -1.5%/ -2.1%/ -1.9% vs -0.8% for placebo. Safety was consistent with prior studies; common adverse events were GI-related and generally mild-to-moderate.

Lilly expects ACHIEVE-4 readout in Q1 2026 and plans regulatory submissions for type 2 diabetes in 2026; obesity submission remains on track for year-end.

Eli Lilly (NYSE: LLY) will present new clinical data at the ESMO Annual Meeting, Oct 17–21, 2025 in Berlin. Highlights include a late-breaking oral seven-year analysis from the Phase 3 monarchE study with the primary overall survival analysis and updated invasive disease-free and distant relapse-free survival for Verzenio (abemaciclib) in HR+, HER2-, node-positive, high-risk early breast cancer.

Additional presentations cover intracranial efficacy of olomorasib (KRAS G12C), updated PIKALO-1 results for LY4064809 (PI3Kα), FORAGER-1 vepugratinib (FGFR3), and Phase 1a/1b LY4170156 (FRα ADC). Lilly said several programs are poised to advance to late-stage studies over the next several months.

Lilly (NYSE: LLY) reported final four‑year LUCENT‑3 results showing Omvoh (mirikizumab‑mrkz) produced sustained, corticosteroid‑free outcomes in moderately to severely active ulcerative colitis through Oct. 7, 2025. Key long‑term results among patients in clinical remission at one year: 78% corticosteroid‑free clinical remission, 78% sustained clinical remission, 81% endoscopic remission (subscore 0–1), 66% histologic‑endoscopic mucosal improvement, 90% IBDQ remission, and 93% achieved ≥3‑point UNRS improvement with 74% UNRS = 0. Safety over four years was consistent with known profile; 12% reported serious adverse events and 7% discontinued for adverse events. Data include patients with prior biologic/advanced therapy failure (27%) and were presented at UEG Week Oct. 4–7, 2025.

Eli Lilly (NYSE:LLY) has officially opened its newest Lilly Gateway Labs (LGL) site in San Diego, California. The 82,514 square foot facility, located at One Alexandria Square Megacampus in Torrey Pines, will accommodate up to 15 biotech companies and over 250 employees.

The facility represents Lilly's fourth U.S. Gateway Labs location, joining existing sites in South San Francisco and Boston. Since 2019, LGL-based companies have raised over $2 billion in capital and developed 50+ therapeutics and platforms. The initiative is part of Lilly Catalyze360, which includes Lilly Ventures, ExploR&D, and TuneLab, providing strategic capital, lab space, and R&D capabilities to support biotech innovation.

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.