Lilly Eli & Co Stock Price, News & Analysis

Eli Lilly announced positive results from the phase 2 SYNERGY-NASH study evaluating tirzepatide for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. The study enrolled 190 patients and showed that 51.8% to 73.3% of participants achieved MASH resolution without worsening fibrosis, compared to 13.2% on placebo at 52 weeks. Additionally, 53.3% to 59.1% saw a 1-stage improvement in fibrosis, compared to 32.8% on placebo. Secondary endpoints indicated improvements in body weight, liver injury markers, and liver fat biomarkers. The results were presented at the EASL Congress 2024 and published in The New England Journal of Medicine. Common adverse events were mild to moderate gastrointestinal issues. Lilly is in dialogue with regulatory authorities for the next steps in tirzepatide's development for MASH.

Eli Lilly and Company (NYSE: LLY) announced the resignation of Anat Ashkenazi, their Chief Financial Officer, effective July 2024. Ashkenazi is leaving to pursue a career opportunity outside the pharmaceutical industry. She has been with Lilly for 23 years, serving as CFO for the last three years, a period marked by significant growth for the company. Prior to her role as CFO, she held several key financial positions, including senior vice president, controller, and CFO of Lilly Research Laboratories. The company has initiated an internal and external search for her successor.

Eli Lilly and Co. (NYSE: LLY) announced that Melissa Seymour will join as executive vice president of Global Quality and Executive Committee member, effective July 22, 2024.

Seymour, currently the chief quality officer at Bristol Myers Squibb, succeeds Johna Norton, who is retiring after 34 years of service. Seymour brings over 25 years of experience in pharmaceutical quality leadership, having worked with companies like Biogen, Novo Nordisk, and Glaxo Smith Kline.

CEO David A. Ricks emphasized Seymour's expertise in quality initiatives and her role in maintaining Lilly's high standards. Seymour expressed enthusiasm about contributing to Lilly's commitment to patient health and safety.

Seymour holds degrees in biological sciences and biochemistry from North Carolina State University and an MBA from Duke University. She is also actively involved in industry organizations and holds several quality-related certifications.

Eli Lilly has released updated data from the Phase 1/2 clinical trial of olomorasib, an investigational second-generation KRAS G12C inhibitor. The data, presented at the 2024 ASCO Annual Meeting, showed promising efficacy and tolerability in patients with KRAS G12C-mutant advanced solid tumors, including NSCLC. Olomorasib demonstrated an objective response rate (ORR) of 35% across non-CRC solid tumors and 41% in NSCLC patients previously treated with a KRAS G12C inhibitor. In combination with pembrolizumab, the ORR for first-line metastatic NSCLC was 77%. Common treatment-related adverse events (TRAEs) were mostly mild, with diarrhea, nausea, and fatigue being the most frequent. The study also highlighted preliminary CNS activity in NSCLC patients with brain metastases. Eli Lilly aims to further investigate olomorasib in combination therapies for first-line NSCLC through the ongoing SUNRAY-01 trial.

Eli Lilly (NYSE: LLY) announced a new $6.5 million donation to UNICEF during the World Health Assembly, bringing their total commitment since 2022 to over $20 million. This funding aims to improve health outcomes for children and youth at risk of noncommunicable diseases (NCDs) in resource- areas in India. The initiative will target diseases like type 1 diabetes, respiratory illnesses, and heart diseases, emphasizing prevention, management, and strengthening health systems. This effort aligns with Lilly’s 30x30 initiative to enhance healthcare access for 30 million people in under-resourced settings by 2030.

Eli Lilly and Company (NYSE: LLY) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024.

Patrik Jonsson, executive vice president and president of Lilly Diabetes and Obesity, as well as president of Lilly USA, will join a fireside chat at 4 p.m. Eastern time.

A live audio webcast will be accessible on Lilly's Investor website, with a replay available for 90 days.

Eli Lilly announced an additional $5.3 billion investment in its Lebanon, Indiana manufacturing site, raising its total investment there to $9 billion. This expansion aims to boost the production of active pharmaceutical ingredients (API) for Zepbound (tirzepatide) and Mounjaro (tirzepatide), addressing high demand for these treatments in obesity and type 2 diabetes. Since 2020, Lilly has committed over $18 billion towards developing and upgrading facilities in the U.S. and Europe. The Lebanon site will create 200 new full-time jobs and over 5,000 construction jobs, with operations expected to start in 2026 and scale up by 2028.

Eli Lilly (NYSE: LLY) will present data on Verzenio, Retevmo, olomorasib, and imlunestrant at the 2024 ASCO Annual Meeting from May 31 to June 4 in Chicago.

Key highlights include:

1. Verzenio: Late-breaking outcomes from the Phase 3 postMONARCH study on HR+, HER2- breast cancer.

2. Retevmo: Safety and efficacy results from the Phase 1/2 LIBRETTO-121 study for pediatric patients with RET-altered tumors.

3. Olomorasib: Updated results for KRAS G12C-mutant cancer treatments.

4. Imlunestrant: Early-phase data on combinations with HER2 therapy.

An investor event will update Lilly's oncology strategy on June 2, 7:30 p.m. CDT, available via webcast.

Eli Lilly's Phase 3 VIVID-1 study indicates that more than half of patients with Crohn's disease treated with mirikizumab achieved clinical remission after one year, including those with prior biologic failures. Nearly half also achieved an endoscopic response. The study demonstrates significant improvements compared to placebo, with 54.1% achieving clinical remission and 48.4% achieving endoscopic response. Mirikizumab showed higher combined remission and endoscopic response rates compared to ustekinumab, especially among patients with previous biologic failures. Lilly has submitted a supplemental Biologics License Application for mirikizumab to the FDA and EMA, with further global submissions planned.