Eli Lilly & Co. develops and commercializes medicines across cardiometabolic disease, oncology, immunology, neuroscience and genetic medicine. Company news commonly covers product and pipeline developments for medicines such as Mounjaro, Zepbound, Foundayo, Omvoh, Verzenio, Jaypirca and Taltz, including clinical data, regulatory approvals and treatment-indication updates.
Lilly updates also include operating results, financial guidance, dividends, business development agreements and manufacturing expansion. Recent company communications highlight investment in active pharmaceutical ingredient capacity and genetic medicine production, alongside recurring disclosures about demand for diabetes, obesity, immune-disease and cancer therapies.
Eli Lilly (LLY) launched a commitment to treat as many people with diabetes and obesity in resource-limited settings as in high-income countries before 2040. Currently, for every four people with access to Lilly's diabetes and obesity medicines in high-income countries, one person in low- and middle-income countries can access them. Lilly plans to consider the needs of resource-limited settings during medicine development, register treatments including GLP-1 medicines in more countries, and work with partners to strengthen primary healthcare systems.
The commitment follows completion of Lilly 30x30, which expanded access to quality healthcare for 40 million people in resource-limited settings in 2025. Its original goal was to reach 30 million people annually by 2030.
Eli Lilly (LLY) received U.S. FDA approval on September 25, 2026, for Olumiant to treat severe alopecia areata in patients aged 12 and older. The approval expands the drug’s U.S. label beyond its existing use for adults with severe alopecia areata.
In the 36-week adolescent cohort of the Phase 3 BRAVE-AA-PEDS study, 42% of patients taking Olumiant 4 mg and 27% taking 2 mg reached at least 80% scalp hair coverage, compared with 5% on placebo. At least 90% coverage was reached by 37%, 21% and 2% of those groups, respectively. The study’s first cohort randomized 257 adolescents aged 12 to under 18.
Olumiant is a once-daily pill. Its recommended dose is 2 mg daily, with an increase to 4 mg if the response is inadequate. The observed pediatric safety profile was consistent with that in adults with severe alopecia areata. The U.S. label carries a boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Eli Lilly (LLY) received U.S. FDA approval on September 24, 2026, for Onswik, a once-weekly basal insulin for adults with type 2 diabetes. It is approved for use alongside diet and exercise to control high blood sugar. The company says the weekly schedule is designed to reduce injections by over 300 per year versus once-daily basal insulin; that comparison does not address safety or effectiveness.
The approval follows four Phase 3 QWINT trials involving over 3,400 adults with type 2 diabetes. Each trial met its primary endpoint for non-inferior A1C reduction versus daily insulin glargine U-100 or insulin degludec U-100. A1C measures average blood sugar.
The Onswik KwikPen is expected to become available in the U.S. in the coming months at 500 units/mL and 1,000 units/mL. Onswik should not be used by people with type 1 diabetes because of an increased risk of severe low blood sugar. Common side effects include low blood sugar and weight gain.
Eli Lilly (LLY) has broken ground on a new $6.5 billion manufacturing site in Houston, Texas, announced on Sept. 21, 2026, to produce active pharmaceutical ingredients (API) for medicines including Foundayo (orforglipron).
The facility is part of Lilly’s $50 billion U.S. reshoring initiative and is one of ten U.S. manufacturing sites announced since 2020, including five API plants. The Houston site will focus on Foundayo, Lilly’s first synthetic oral GLP‑1 medicine for chronic weight management, as well as other small‑molecule medicines and advanced therapeutics such as oligonucleotides.
The site is expected to create more than 600 high‑wage permanent jobs and about 4,000 construction jobs. Lilly will provide $12.5 million to San Jacinto College for workforce training infrastructure and $2.5 million in scholarships, and plans to run the facility with digitally integrated, AI‑enabled manufacturing systems.
Eli Lilly (LLY) received full U.S. FDA approval for Inluriyo (imlunestrant) plus Verzenio (abemaciclib) to treat adults with ER+, HER2–, ESR1‑mutated locally advanced or metastatic breast cancer whose disease has progressed after at least one line of endocrine therapy, with ESR1 mutation detected by an FDA‑authorized test.
The approval is based on Phase 3 EMBER‑3, where Inluriyo+Verzenio after prior aromatase inhibitor±CDK4/6 inhibitor doubled median progression‑free survival versus Inluriyo alone (11.1 vs 5.5 months; HR=0.53; 95% CI 0.35–0.80) in 159 ESR1‑mutated patients. The all‑oral regimen targets estrogen receptor and CDK4/6 pathways and showed a safety profile consistent with the individual drugs, with most adverse events Grade 1–2 but 21% serious and 3.8% fatal reactions in the combination arm. The combination is now available in the United States.
Eli Lilly (LLY) will present extensive new data on Foundayo (orforglipron), retatrutide and eloraTZP at the EASD 2026 meeting in Milan from September 28 to October 2, 2026.
Pivotal Phase 3 TRIUMPH-2 results for investigational triple agonist retatrutide showed adults with obesity or overweight and type 2 diabetes lost up to an average of 49.6 lbs (22.5 kg; 20.8%) and reduced A1C by up to 1.6% at 80 weeks. Phase 3 ACHIEVE-4 data for Foundayo in type 2 diabetes demonstrated non-inferiority versus insulin glargine, with hazard ratios of 0.84 for MACE-4 and 0.77 for MACE-3 in adults at increased cardiovascular risk.
Lilly will also share a Phase 2 eloraTZP combination dataset, multiple oral and poster presentations on Foundayo, Zepbound and Mounjaro, and early data showing 17% weight loss over 16 weeks when adding eloralintide 3 mg to tirzepatide 5 mg versus 10% with tirzepatide alone.
Eli Lilly (LLY) has completed its acquisition of clinical-stage biopharma company AtaiBeckley, which develops rapid-acting neuroplastogens for mental health conditions, including lead investigational program BPL-003 for treatment-resistant depression.
The deal received approval from AtaiBeckley shareholders at a special meeting held prior to closing. Lilly highlights that treatment-resistant depression persists despite multiple treatment attempts and says AtaiBeckley’s neuroplastogens may enable a new treatment paradigm focused on rapid-acting therapeutics that move away from chronic dosing. Lilly states it is committed to advancing these programs to expand options for people living with severe mental health conditions.
Eli Lilly (NYSE: LLY) will participate in the Morgan Stanley 24th Annual Global Healthcare Conference on September 14, 2026. Ilya Yuffa, executive vice president and president, Lilly USA and Global Customer Capabilities, will join a fireside chat at 1:50 p.m. Eastern time.
A live audio webcast and a replay (available for about 90 days) will be accessible through the “Webcasts & Presentations” section of Lilly's investor website.
Eli Lilly (NYSE: LLY) reported 52-week Phase 3b results from the TOGETHER-PsO and TOGETHER-PsA trials, which evaluated concomitant Taltz (ixekizumab) plus Zepbound (tirzepatide) versus Taltz alone in adults with moderate-to-severe plaque psoriasis or active psoriatic arthritis and obesity or overweight with a weight-related comorbidity.
At Week 52, the primary composite outcomes (maximal disease control plus ≥10% weight loss) favored combination therapy: in TOGETHER-PsO, 30.6% on Taltz+Zepbound versus 4.4% on Taltz alone achieved PASI 100 plus ≥10% weight loss; in TOGETHER-PsA, ACR50 plus ≥10% weight loss was achieved by 39.2% versus 1.7%, respectively. Complete skin clearance (PASI 100) in psoriasis was 40.5% with combination vs 29.1% with monotherapy, and ACR50 responses in psoriatic arthritis increased to 43.7% vs 15.7%.
According to Lilly, improvements in systemic inflammation (hsCRP), BMI and multiple metabolic measures were sustained or further improved through one year, with no new safety concerns; adverse events were generally mild to moderate and consistent with known profiles of each medicine.
Lilly (NYSE: LLY) has signed a definitive agreement to acquire Merida Biosciences, a biotechnology company developing precision biologics for serious autoimmune and allergic diseases. Merida’s antibody-engineering platform is designed to selectively and durably remove disease-causing antibodies while preserving normal immune function.
Merida’s lead asset, MER511, is in Phase 1 for Graves’ disease and thyroid eye disease, with initial data showing robust reductions in pathogenic thyroid-stimulating antibodies and a favorable initial safety profile. The pipeline also includes MER769, a preclinical program for food allergy, asthma, chronic spontaneous urticaria and other IgE‑driven diseases, plus earlier programs in kidney and other immune-mediated conditions.
According to Lilly, the deal is valued at up to $2.875 billion in cash, including an upfront payment and contingent milestone payments. The transaction is subject to customary closing conditions and regulatory approvals and is expected to close in the fourth quarter of 2026, after which it will be reflected in Lilly’s GAAP financial results and guidance.