Eli Lilly & Co. - LLY STOCK NEWS

Gan & Lee Pharmaceuticals announced FDA clearance of their IND application for GZR18 Injection, a bi-weekly GLP-1 receptor agonist, to conduct a Phase 2 clinical trial. The trial will be a head-to-head comparison with Eli Lilly's Tirzepatide for chronic weight management in obese or overweight patients, with or without T2DM.

According to the World Obesity Federation's 2024 report, approximately 2.2 billion adults worldwide were overweight in 2020, with projections reaching 3.3 billion by 2035. GZR18, as the first bi-weekly GLP-1 mono-agonist formulation, works by delaying gastric emptying and suppressing appetite. Current clinical data suggests weight loss effects comparable to or better than multi-target once-weekly GLP-1 formulations.

Eli Lilly's Kisunla™ (donanemab-azbt) has received approval from China's National Medical Products Administration for treating early symptomatic Alzheimer's disease. This marks China as the fourth major market to approve Kisunla, following approvals in the US, Japan, and Great Britain in 2024. The treatment targets adults with mild cognitive impairment and mild dementia stage of Alzheimer's with confirmed amyloid pathology.

In clinical trials, Kisunla demonstrated significant results, showing a 35% slowing of decline in less advanced patients and 22% in the overall population. The drug reduced amyloid plaques by 61% at 6 months, 80% at 12 months, and 84% at 18 months. Notably, 66% of patients achieved plaque clearance at one year, allowing them to complete treatment.

Eli Lilly (NYSE: LLY) and EVA Pharma announced the Egyptian Drug Authority's approval of locally manufactured insulin glargine injection. This achievement stems from their 2022 collaboration aimed at providing affordable insulin to one million people with diabetes in low- to middle-income countries annually by 2030.

EVA Pharma has completed a new biologics facility and obtained regulatory approval in less than two years. Lilly supplies the active pharmaceutical ingredient at reduced prices and provides technology transfer support. EVA Pharma has also submitted human insulin injection for local regulatory approval and is working with WHO for pre-qualification.

The companies recently expanded their partnership to include baricitinib manufacturing for immunological diseases across 56 low- to middle-income countries in Africa.

Innovent Biologics and Eli Lilly have announced a Distribution and Promotion Agreement for Jaypirca® (pirtobrutinib) in Mainland China. Under the agreement, Innovent will handle importation, marketing, distribution, and promotion, while Lilly maintains responsibility for R&D and post-market medical affairs.

Jaypirca® is the first and only approved non-covalent BTK inhibitor, receiving FDA approval in January 2023 and NMPA approval in October 2024. It's indicated for adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor.

The collaboration aims to leverage Innovent's established hematology oncology commercial team and Lilly's expertise in drug development to improve cancer patient outcomes in Mainland China.

Eli Lilly's Omvoh® (mirikizumab) received a positive recommendation from EMA's CHMP for treating adults with moderately to severely active Crohn's disease. The recommendation is based on the Phase 3 VIVID-1 trial, which demonstrated significant improvements in endoscopic response, clinical remission, and bowel urgency symptoms. Omvoh would be the first Crohn's disease treatment showing improvements in histologic measures of inflammation in its label.

Already approved in 44 countries for ulcerative colitis, Omvoh awaits European Commission's final decision in the next 1-2 months. The drug is also under review in the U.S., with a decision expected in first half of 2025.

Eli Lilly (LLY) announced significant results from the Phase 3 EMBER-3 study of imlunestrant, an oral selective estrogen receptor degrader (SERD), in patients with ER+, HER2- advanced breast cancer. As monotherapy, imlunestrant reduced the risk of progression or death by 38% compared to standard endocrine therapy in patients with ESR1 mutations. When combined with Verzenio, it reduced this risk by 43% versus imlunestrant alone.

The median progression-free survival was 5.5 months with imlunestrant versus 3.8 months with standard therapy in ESR1 mutation patients. The combination therapy showed 9.4 months median progression-free survival compared to 5.5 months for imlunestrant alone. The safety profile was consistent with known data, showing mostly low-grade adverse events and a low discontinuation rate of 6.3%.

Eli Lilly announced positive Phase 3 results for Jaypirca (pirtobrutinib) in treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The BRUIN CLL-321 trial showed that pirtobrutinib reduced disease progression or death risk by 46% compared to alternative treatments.

Key findings include:

• Median progression-free survival of 14.0 months vs 8.7 months in control group
• Time to next treatment extended by 23.9 months vs 10.9 months
• Improved safety profile with fewer grade 3 adverse events

The study involved 238 patients who had received at least one prior BTK inhibitor treatment, marking the first randomized Phase 3 study in CLL conducted exclusively in BTK inhibitor pre-treated patients.

Eli Lilly has announced a new $15 billion share repurchase program, following the completion of its previous $5 billion program in Q4 2024. The company's board of directors has also approved a 15% increase in quarterly dividend to $1.50 per share, marking the seventh consecutive year of such increases.

The dividend will be payable on March 10, 2025, to shareholders of record as of February 14, 2025. The company plans to execute the share repurchase program over three years through various methods, including open market purchases and accelerated share repurchases, while maintaining focus on supporting new launches, expanding manufacturing capacity, and advancing pipeline development.

CORE Kidney, Boehringer Ingelheim, and Eli Lilly (NYSE: LLY) announced their collaboration at the 2025 Tournament of Roses® Parade to raise awareness about kidney disease testing. The initiative features Pro Football Hall of Famer Brian Dawkins and emphasizes the importance of complete testing - both blood and urine tests - for kidney disease detection.

The campaign highlights alarming statistics: over 35 million U.S. adults have kidney disease, yet about 90% are unaware of their condition. Less than 20% of at-risk individuals receive both required tests. The parade float, titled 'It's In Your Hands: It Takes 2,' will feature a remixed version of Rob Base's 'It Takes Two' to promote the message of complete kidney disease screening.