Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly announced positive Phase 2 results for muvalaplin, an oral once-daily treatment that significantly reduced lipoprotein(a) [Lp(a)] levels in adults at high risk for cardiovascular events. The study met its primary endpoint, showing placebo-adjusted reductions up to 85.8% using an intact Lp(a) assay and up to 70.0% using an apo(a) assay at week 12. The drug was tested at three doses (10mg, 60mg, 240mg), with all doses achieving statistical significance for Lp(a) thresholds. Adverse events were similar between muvalaplin and placebo groups, with treatment-related events occurring in 5.9-14.7% of treatment groups.

Eli Lilly announced significant results from the SUMMIT Phase 3 trial of tirzepatide for heart failure with preserved ejection fraction (HFpEF) and obesity. The drug demonstrated a 38% reduction in heart failure events risk and 56% reduction in hospitalization risk compared to placebo. Patients showed improved heart failure symptoms, with a 25-point improvement in the KCCQ-CSS score versus 15 points for placebo. Key secondary endpoints revealed patients achieved 15.7% average weight loss and walked approximately 30 meters farther in six minutes than the placebo group. The drug also reduced systemic inflammation marker hsCRP by 43.4%. Lilly has initiated regulatory submissions globally.

Eli Lilly's three-year Phase 3 SURMOUNT-1 study shows that tirzepatide significantly reduced type 2 diabetes risk in adults with pre-diabetes and obesity. The study demonstrated a 94% reduction in diabetes progression risk compared to placebo, with nearly 99% of treated participants remaining diabetes-free at 176 weeks. Participants achieved sustained weight loss averaging 22.9% with the 15 mg dose. The results suggest that one new case of diabetes could be prevented for every nine patients treated. The treatment also showed improvements in glycemic control, cardiometabolic risk factors, and health-related quality of life. Common side effects were primarily gastrointestinal and mild to moderate.

Asha Therapeutics has received a grant from the ALS Association's Barnett Drug Development Program to advance ASHA-624, a novel brain-penetrant intra-molecular glue inhibitor of SARM1, towards clinical trials for ALS treatment. The drug, designed using Asha's PRISM™ technology, has shown promising results in preclinical trials, demonstrating neuroprotection and restored motor function. The company also announced the appointment of SARM1 experts Dr. Jeffrey Milbrandt and Dr. Aaron DiAntonio, founders of Disarm Therapeutics (acquired by Eli Lilly), along with Dr. Jeffrey Rothstein to its Scientific Advisory Board.

Eli Lilly (NYSE: LLY) announced upcoming presentations at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, December 7-10. The key highlight is the Phase 3 BRUIN CLL-321 study results of Jaypirca® (pirtobrutinib), evaluating its effectiveness versus idelalisib plus rituximab or bendamustine plus rituximab in BTK inhibitor pretreated patients with CLL/SLL. This is the first randomized Phase 3 study focusing on BTK inhibitor pretreated CLL population. Additional presentations include real-world data analyses on overall survival in CLL/SLL patients and pre-clinical data for a novel BAFF-RxCD3 bispecific antibody.

Eli Lilly will present data from its Phase 3 EMBER-3 trial for imlunestrant, an oral selective estrogen receptor degrader (SERD), at the San Antonio Breast Cancer Symposium in December 2024. The study evaluates imlunestrant alone and combined with Verzenio in ER+, HER2- advanced breast cancer patients previously treated with endocrine therapy. The company will also share real-world analysis of recurrence risk in HR+, HER2- early breast cancer and present data on its PI3Ka inhibitor programs, including preclinical data for LY4045004 and Phase 1a/b results for LOXO-783.

Eli Lilly (LLY) reported strong Q3 2024 financial results with revenue increasing 20% to $11.44 billion. Excluding olanzapine portfolio revenue, total revenue grew 42%, driven by volume growth from Mounjaro and Zepbound. Q3 2024 EPS increased to $1.07 (reported) and $1.18 (non-GAAP). The company updated its 2024 guidance, projecting revenue of $45.4-$46.0 billion and EPS of $12.05-$12.55 (reported) and $13.02-$13.52 (non-GAAP). Key achievements included FDA approval of Ebglyss for atopic dermatitis and positive Phase 3 data showing 94% reduction in type 2 diabetes risk with tirzepatide.

Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study for Kisunla (donanemab) in early symptomatic Alzheimer's disease. A modified titration dosing regimen, which shifted one vial from the first infusion to the third infusion, reduced ARIA-E incidence to 14% compared to 24% with standard dosing. The reduction was most significant in APOE4 homozygotes, dropping from 57% to 19%. The modified regimen maintained comparable amyloid plaque reduction (67% vs 69%) and P-tau217 levels. Lilly plans to submit this data to regulators for a potential label update.

Eli Lilly (NYSE: LLY) has announced its quarterly dividend payment for Q4 2024. The company's board of directors has declared a dividend of $1.30 per share on outstanding common stock. The dividend will be paid on December 10, 2024, to shareholders who are on record as of November 15, 2024.