Lilly Eli & Co Stock Price, News & Analysis

Lilly (NYSE: LLY) reported 52-week Phase 3 BRAVE-AA-PEDS results showing once-daily oral baricitinib 4 mg produced substantial hair regrowth in adolescents (ages 12 to <18) with severe alopecia areata.

Key one-year outcomes: 54.1% achieved ≥80% scalp hair coverage (SALT ≤20) on 4 mg versus 31% on 2 mg; 41.2% on 4 mg achieved ≥90% scalp coverage (SALT ≤10). In the severe-disease subgroup (SALT 50–94), 71% on 4 mg achieved successful regrowth. Eyebrow and eyelash regrowth rates were also higher on 4 mg. Safety was consistent with prior trials; no deaths, opportunistic infections, MACEs, or VTEs were reported.

Lilly plans to submit these adolescent data to global regulators for a potential label update for Olumiant and to enroll younger children in BRAVE-AA-PEDS.

Eli Lilly (NYSE: LLY) reported Phase 3 ADjoin extension data on Oct. 24, 2025 showing EBGLYSS (lebrikizumab-lbkz) maintained high disease control when switched from monthly maintenance dosing to a single 250 mg injection every eight weeks (Q8W).

Key results: EASI-75 rates were 79% Q8W vs 86% Q4W; IGA 0,1 rates were 62% Q8W vs 73% Q4W. No new safety signals or increased immunogenicity were observed. Lilly submitted these data to the FDA seeking a potential label update to offer an every-eight-week maintenance option; an every-twelve-week study is underway.

Lilly (NYSE: LLY) announced primary overall survival results from the Phase 3 monarchE trial showing two years of adjuvant Verzenio (abemaciclib) plus endocrine therapy reduced the risk of death by 15.8% versus endocrine therapy alone (7-year OS: 86.8% vs 85.0%; HR 0.842; 95% CI 0.722–0.981; 2-sided p=0.027) with median follow-up of 6.3 years. The regimen also showed sustained benefits in invasive disease-free survival and distant relapse-free survival, and 32% fewer patients were living with metastatic disease (6.4% vs 9.4%). Safety was consistent with prior analyses; data were published in Annals of Oncology and presented at ESMO on Oct 17, 2025.

Eli Lilly (NYSE: LLY) will release its third-quarter 2025 financial results on October 30, 2025.

The company will host a conference call for investors and media on the same day beginning at 10:00 a.m. Eastern time, with a live webcast and a replay available via the investor website at https://investor.lilly.com/webcasts-and-presentations.

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.