Lilly Eli & Co - LLY STOCK NEWS

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.

Eli Lilly (NYSE: LLY) announced a $3 billion expansion of its Kenosha County, Wisconsin manufacturing facility. The expansion will enhance the company's injectable product manufacturing network to meet growing demand for diabetes, obesity, and future pipeline medicines. The project will add 750 highly skilled jobs to the current 100-plus workforce.

Construction is set to begin in 2025. Combined with the initial acquisition, land purchases, and warehouse additions, Lilly's total planned investment in Wisconsin reaches $4 billion. The facility will utilize advanced automation, including guided vehicles, robotics, and digital automation for medicine production. The project will also create over 2,000 construction jobs during the expansion phase.

Eli Lilly's Zepbound demonstrated superior weight loss results compared to Wegovy in the SURMOUNT-5 phase 3b clinical trial. Participants using Zepbound achieved an average weight loss of 20.2% (50.3 lbs) compared to 13.7% (33.1 lbs) with Wegovy, representing a 47% greater relative weight loss.

The trial met both its primary endpoint and all five key secondary endpoints. Notably, 31.6% of Zepbound users achieved at least 25% body weight loss versus 16.1% for Wegovy users. The safety profile was consistent with previous SURMOUNT trials, with mainly mild to moderate gastrointestinal-related adverse events reported for both medications.

Eli Lilly announced changes to its board of directors. Jon Moeller, chairman, president and CEO of Procter & Gamble, will join the board effective Dec. 1, 2024, serving on the Audit Committee and Directors and Corporate Governance Committee. Karen Walker will resign from the board effective Dec. 31, 2024, but will continue collaborating with Lilly on digital commercial activities in 2025. Walker has served since 2018 on the Audit and Talent and Compensation Committees, bringing expertise in brand-building and go-to-market strategy during a period of significant growth for Lilly.

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.