Lilly Eli & Co - LLY STOCK NEWS

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.

Eli Lilly announced breakthrough results from two Phase 3 studies demonstrating the long-term effectiveness of mirikizumab in treating inflammatory bowel diseases. The drug showed remarkable success in maintaining remission for patients with ulcerative colitis and Crohn's disease.

After three years, over 80% of ulcerative colitis patients maintained remission and symptom relief. For Crohn's disease patients, more than 50% sustained endoscopic remission for up to five years. Mirikizumab, the first IL23p19 antagonist to report such long-term data, demonstrated a consistent safety profile across both conditions.

The drug is already FDA-approved for ulcerative colitis treatment and is under review for Crohn's disease. These findings were presented at the American College of Gastroenterology Annual Meeting 2024.

Eli Lilly's EBGLYSS (lebrikizumab-lbkz) demonstrated significant efficacy in treating moderate-to-severe atopic dermatitis patients who previously discontinued dupilumab. In the Phase 3b ADapt study, 57% of patients achieved EASI-75 at Week 16, and 60% at Week 24. The treatment showed particular effectiveness in difficult-to-treat areas, with 52% of patients achieving clear or almost clear face dermatitis at Week 24. The drug's safety profile remained consistent with previous studies, with less than 6% of patients discontinuing due to adverse events. EBGLYSS, recently approved by the FDA, is administered as a monthly maintenance injection following an initial treatment phase.

Eli Lilly's Kisunla™ (donanemab) has received marketing authorization in Great Britain for treating mild cognitive impairment and mild dementia due to Alzheimer's disease in specific adult patients. The approval is to apolipoprotein E ε4 heterozygotes or non-carriers. This marks Great Britain as the third major market to approve donanemab, following approvals in the United States (July 2024) and Japan (September 2024). The drug, administered via intravenous infusion every four weeks, is unique as the only amyloid plaque-targeting therapy with evidence supporting treatment discontinuation after plaque removal. In the UK, where an estimated 982,000 people live with dementia, the total cost of dementia care is projected at £42 billion in 2024.