Lilly Eli & (LLY) Stock News

Eli Lilly (NYSE:LLY) has received FDA approval for an updated label with a new dosing schedule for Kisunla (donanemab-azbt), its monthly Alzheimer's treatment. The modified titration schedule demonstrated a 41% reduction in ARIA-E incidents at 24 weeks and 35% reduction at 52 weeks compared to the original dosing.

The new dosing maintains Kisunla's efficacy while improving safety, achieving similar amyloid plaque removal (67% reduction vs. 69% originally) and P-tau217 reduction. The treatment, initially approved in July 2024, has shown to slow cognitive decline by up to 35% in less advanced patients and 22% in the overall population.

Eli Lilly (NYSE: LLY) has announced its quarterly dividend payment for Q3 2025. The company's board of directors has declared a dividend of $1.50 per share on outstanding common stock. Shareholders who are on record as of August 15, 2025, will receive the dividend payment on September 10, 2025. This dividend declaration demonstrates Lilly's commitment to providing regular returns to its shareholders through dividend distributions.

Eli Lilly announced positive Phase 3 trial results for efsitora alfa, a novel once-weekly insulin treatment for type 2 diabetes. The QWINT-1, QWINT-3, and QWINT-4 trials demonstrated that efsitora met primary endpoints for A1C reduction compared to daily basal insulin. In QWINT-1, efsitora reduced A1C by 1.31% vs 1.27% for insulin glargine at 52 weeks. QWINT-3 showed 0.86% reduction vs 0.75% for insulin degludec, while QWINT-4 achieved 1.07% reduction matching insulin glargine. The drug's safety profile was comparable to common daily basal insulins, with QWINT-1 showing 40% fewer hypoglycemic events. Notably, efsitora's once-weekly dosing could eliminate over 300 injections annually. Lilly plans to submit efsitora for regulatory approval by year-end.

Eli Lilly announced positive Phase 3 ACHIEVE-1 trial results for orforglipron, their first-in-class oral GLP-1 receptor agonist for type 2 diabetes. The once-daily pill demonstrated significant A1C reductions of 1.3% to 1.6% from baseline across doses (3mg, 12mg, 36mg) at 40 weeks. The highest dose achieved notable weight loss of 16.0 lbs (7.9%). Up to 76.2% of participants reached target A1C levels <7%. The drug showed early efficacy within four weeks and maintained a safety profile consistent with injectable GLP-1s, with mainly gastrointestinal side effects. Importantly, orforglipron requires no food or water restrictions, potentially offering a convenient alternative to injectable treatments. Lilly plans regulatory submissions for weight management in 2025 and type 2 diabetes in 2026, with additional trial results expected later this year.

Eli Lilly (NYSE: LLY) has announced a definitive agreement to acquire Verve Therapeutics (Nasdaq: VERV), a clinical-stage biotech company specializing in genetic medicines for cardiovascular disease. The deal values Verve at $10.50 per share in cash ($1.0 billion), plus a CVR worth up to $3.00 per share, potentially reaching $13.50 per share ($1.3 billion total). Verve's lead program, VERVE-102, is a first-in-class in vivo gene editing treatment targeting PCSK9 for cardiovascular disease, designed as a one-time treatment for conditions like heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease. The FDA has granted Fast Track designation to VERVE-102, currently in Phase 1b trials. The acquisition price represents a 113% premium to Verve's 30-day volume-weighted average trading price, with the deal expected to close in Q3 2025.

Eli Lilly (NYSE: LLY) announced that Zepbound's highest approved doses (12.5 mg and 15 mg) will be available in single-dose vials for $499/month through LillyDirect's Self Pay Pharmacy Solutions starting July 7, 2025. All Zepbound doses will now be accessible at $499/month or less ($349 for starter dose), regardless of insurance status. In clinical trials, adults taking Zepbound 15 mg achieved remarkable results, with average weight loss of 48 lbs (~21%) and approximately one-third losing over 58 lbs (25%). The complete range includes 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses, with pricing through the Self Pay Journey Program ranging from $349-$1,049, but capped at $499 with program benefits. The medication is indicated for adults with obesity or overweight with weight-related conditions and has shown significant efficacy in both diabetic and non-diabetic populations.

Eli Lilly (NYSE:LLY) announced its participation in the Goldman Sachs 46th Annual Global Health Care Conference scheduled for June 10, 2025. The company's executive vice president and CFO, Lucas Montarce, will participate in a fireside chat at 8 a.m. Eastern time. Investors can access a live audio webcast of the presentation through Lilly's investor website, with a replay available for approximately 90 days following the event.

Eli Lilly (LLY) presented promising Phase 1 data for its folate receptor alpha (FRα) antibody-drug conjugate (LY4170156) in treating platinum-resistant ovarian cancer. The drug showed a 55% overall objective response rate (ORR) at the recommended Phase 2 dose of 4 mg/kg. The study included 95 patients with high-grade serous ovarian cancer, with efficacy demonstrated across all FRα expression levels, including patients previously treated with mirvetuximab soravtansine. The drug showed a favorable safety profile with common side effects including nausea (64%), anemia (40%), and fatigue (32%). Notably, no treatment-emergent neuropathy or ocular toxicity was observed. The overall disease control rate was 74% among the 58 efficacy-evaluable patients, suggesting potential significant expansion of treatment options for ovarian cancer patients.

Eli Lilly (NYSE: LLY) will present data from multiple studies at the American Diabetes Association's 85th Scientific Sessions (June 20-23, 2025) in Chicago. Key presentations will feature results from several investigational drugs: • Orforglipron: ACHIEVE-1 Phase 3 trial results for this small molecule GLP-1 receptor agonist • Insulin efsitora alfa: QWINT-1, QWINT-3, and QWINT-4 Phase 3 trial results for this once-weekly basal insulin • Bimagrumab: BELIEVE Phase 2b trial results evaluating this activin pathway inhibitor alone and with semaglutide • Tirzepatide (Zepbound/Mounjaro): Multiple presentations including SURMOUNT-1 176-week data and SURMOUNT-5 comparison vs semaglutide • Retatrutide and Eloralintide: Preclinical and early clinical data Lilly will host an investor event on June 22 to discuss key presentations and their cardiometabolic health portfolio.