Verzenio (abemaciclib)
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BofA Maintains Buy on Eli Lilly (LLY), Expects 2027 Earnings to Fully Realize Value of Obesity Drug Launches
Yahoo Finance· 2025-12-22 13:42
Eli Lilly and Company (NYSE:LLY) is one of the best growth stocks to buy in 2026. On December 15, Bank of America analyst Jason Gerberry lowered the firm’s price target on Eli Lilly to $1,268 from $1,286 with a Buy rating on the shares. BofA remains bullish on Eli Lilly’s stock due to the company’s successful obesity product launches and the steady expansion of its pipeline into new therapeutic areas. 2027 projected earnings are expected to better capture the company’s long-term growth potential. In othe ...
Updated data for Lilly's Inluriyo™ (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio® (abemaciclib) in ER+, HER2- advanced breast cancer
Prnewswire· 2025-12-12 16:45
Core Insights - Imlunestrant (Inluriyo) shows significant clinical benefits in treating ER+ HER2- advanced or metastatic breast cancer, with an 11.4-month improvement in median overall survival (OS) compared to endocrine therapy in patients with ESR1 mutations [1][3] - The combination of imlunestrant and abemaciclib resulted in a median progression-free survival (PFS) of 10.9 months and extended time to chemotherapy by over a year [1][3] - The updated data from the Phase 3 EMBER-3 study reinforces the role of imlunestrant in this treatment setting, with ongoing regulatory review for the combination therapy [3][4] Study Results - As monotherapy, imlunestrant achieved a 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62) and an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60) in ESR1-mutated patients [1][3] - The combination therapy reduced the risk of progression or death by 41% compared to imlunestrant alone, with a median PFS of 10.9 months [1][3] - In patients with ESR1 mutations, median PFS was extended to 11.0 months with the combination therapy [3][4] Safety and Efficacy - Safety profiles for imlunestrant-based regimens were consistent with previous reports, with no new safety signals observed [4] - Most patients (65%) in the combination arm had previously received a CDK4/6 inhibitor, indicating a durable benefit across efficacy endpoints [3][4] - Follow-up for OS is ongoing, with additional analyses planned as data mature [4] Future Directions - Imlunestrant is also being investigated in the adjuvant setting for ER+ HER2- early breast cancer with increased recurrence risk, with the EMBER-4 trial enrolling approximately 8,000 patients [5][6] - The ongoing studies aim to further establish the efficacy and safety of imlunestrant in various treatment settings [5][6]
Lilly to highlight progress across key programs in early and advanced hormone receptor-positive breast cancer at the 2025 San Antonio Breast Cancer Symposium
Prnewswire· 2025-11-24 21:30
Core Insights - Eli Lilly and Company is set to present new data from its breast oncology portfolio at the San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025, highlighting advancements in treatments for ER+, HER2– metastatic breast cancer [1][2][5] Group 1: Inluriyo (imlunestrant) - Updated results from the Phase 3 EMBER-3 trial will be shared, focusing on Inluriyo alone and in combination with Verzenio in patients with ER+, HER2– advanced or metastatic breast cancer, including overall survival and progression-free survival analyses [2][5] - An exploratory analysis of early changes in circulating tumor DNA (ctDNA) and its correlation to clinical outcomes will also be presented [2] Group 2: Verzenio (abemaciclib) - A subgroup analysis from the Phase 3 monarchE trial will evaluate the efficacy of adjuvant abemaciclib plus endocrine therapy based on nodal status in high-risk early breast cancer patients [3][5] - Recent results indicated that this combination therapy prolonged overall survival and improved invasive disease-free survival and distant relapse-free survival [3] Group 3: LY4064809 (STX-478) - Findings from the ongoing Phase 1/2 PIKALO-1 study of LY4064809, a pan-mutant-selective PI3K inhibitor, will be presented, including safety and efficacy data across various patient subgroups [4][5] - LY4064809 is planned to advance into the Phase 3 PIKALO-2 study, with ongoing dose optimization [4] Group 4: Company Commitment - Eli Lilly emphasizes its commitment to addressing key biological targets in HR+ breast cancer, including CDK4/6, estrogen receptor, and PI3K, reflecting the momentum of its breast oncology portfolio [5]
Lilly's EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis
Prnewswire· 2025-10-24 10:45
Core Insights - Eli Lilly's EBGLYSS (lebrikizumab-lbkz) shows promising results in treating moderate-to-severe atopic dermatitis, with approximately 80% of patients achieving or maintaining meaningful skin improvement with less frequent dosing [1][5] - The company has submitted new data to the FDA for a potential label update, which could allow for a maintenance dosing schedule of once every eight weeks [1][3] Group 1: Clinical Data and Efficacy - In the Phase 3 ADjoin extension trial, patients receiving EBGLYSS every eight weeks achieved similar disease control rates as those receiving it every four weeks, with 79% and 86% achieving EASI 75, respectively [5][9] - The study also reported that 62% of patients on the eight-week regimen and 73% on the four-week regimen achieved IGA 0 or 1, indicating significant skin clearance [5][9] - There were no new safety findings or increased risk of immunogenicity associated with the less frequent dosing [5][9] Group 2: Treatment Flexibility and Patient Experience - The new dosing schedule could reduce the treatment burden for patients, allowing for as few as six maintenance doses per year, which may enhance patient adherence and quality of life [2][3] - The interleukin-13 (IL-13) inhibitor mechanism of EBGLYSS targets a key cytokine involved in atopic dermatitis, potentially offering a more effective treatment option for patients [2][20] Group 3: Regulatory and Market Position - Lilly is pursuing an FDA label update for the every-eight-week dosing option, while also exploring a twelve-week dosing regimen in ongoing studies [4][3] - EBGLYSS is positioned as a first-line biologic treatment for moderate-to-severe atopic dermatitis, with strong recommendations from the American Academy of Dermatology [4][8] Group 4: Commercial Strategy and Access - Lilly has secured coverage for EBGLYSS with all three major national pharmacy benefit managers, ensuring access for over 90% of individuals with commercial insurance [25] - The company is also working to expand Medicaid and Medicare coverage as part of its health access initiative [25]
Lilly confirms date and conference call for third-quarter 2025 financial results announcement
Prnewswire· 2025-10-16 14:00
Core Insights - Eli Lilly and Company will announce its third-quarter 2025 financial results on October 30, 2025, followed by a conference call for investors and media [1] - The company emphasizes its commitment to advancing healthcare through innovative treatments and clinical trials that reflect global diversity [1] Financial Results Announcement - The financial results will be disclosed on October 30, 2025, with a conference call starting at 10 a.m. Eastern time [1] - A live webcast of the conference call will be available on Lilly's website, with a replay accessible afterward [1] Company Overview - Eli Lilly has been a pioneer in medical discoveries for nearly 150 years, focusing on improving lives through biotechnology, chemistry, and genetic medicine [1] - The company addresses significant health challenges, including diabetes care, obesity treatment, Alzheimer's disease, immune system disorders, and difficult-to-treat cancers [1] - Lilly aims to ensure that its medicines are accessible and affordable while conducting innovative clinical trials [1]
Lilly to present new clinical data for Verzenio (abemaciclib) and multiple novel pipeline programs at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting
Prnewswire· 2025-10-13 10:45
Core Insights - Eli Lilly and Company is presenting new data from its oncology portfolio at the ESMO Annual Meeting, highlighting advancements in cancer care and the efficacy of its investigational therapies [1][7]. Group 1: Verzenio (abemaciclib) - The company will present results from the seven-year analysis of the Phase 3 monarchE study, focusing on overall survival and disease-free survival in high-risk early breast cancer patients [2][10]. - An in-depth analysis of the Ki-67 index's prognostic and predictive value will also be shared, examining its role before and after neoadjuvant chemotherapy [2]. Group 2: Investigational Therapies - Olomorasib, a KRAS G12C inhibitor, will have its intracranial efficacy results presented for patients with KRAS G12C-mutant non-small cell lung cancer [3]. - LY4064809, a pan-mutant-selective PI3Ka inhibitor, will showcase updated results from the Phase 1/2 PIKALO-1 trial in PIK3CA-mutant advanced breast cancer [4]. - Vepugratinib, an FGFR3 inhibitor, will present updated results from the FORAGER-1 study in FGFR3-altered urothelial cancer [5]. - LY4170156, an investigational antibody-drug conjugate targeting folate receptor alpha, will share updated safety and efficacy results in patients with platinum-resistant ovarian cancer [6]. Group 3: Company Commitment - The presentations reflect Lilly's commitment to advancing cancer care and improving patient outcomes, with a focus on strengthening its oncology portfolio [7].
Lilly announces details of presentations at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Prnewswire· 2025-05-22 21:05
Core Insights - Eli Lilly and Company is set to present data on several investigational drugs at the 2025 ASCO Annual Meeting, including imlunestrant, olomorasib, LY4170156, and Verzenio [1] Group 1: Imlunestrant (Investigational Oral SERD) - The company will present patient-reported outcomes from the Phase 3 EMBER-3 trial for patients with ER+, HER2- advanced breast cancer [2] - Expanded safety analyses from the EMBER-3 trial will also be featured in a poster presentation [2] Group 2: Olomorasib (Investigational KRAS G12C Inhibitor) - Updated results from a Phase 1/2 study of olomorasib will be reported, showing preliminary evidence of CNS activity in combination with pembrolizumab for KRAS G12C-mutant advanced NSCLC and with cetuximab for KRAS G12C-mutant colorectal cancer [3] - The presentations will utilize data cut-off dates of January 15, 2025, and November 13, 2024 [3] Group 3: LY4170156 (Investigational ADC Targeting FRα) - Initial results from a Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer will be presented [4] - The study involves a humanized monoclonal antibody linked to a topoisomerase I inhibitor [4] Group 4: Verzenio (Abemaciclib) - The impact of body mass index (BMI) on the efficacy and safety of Verzenio in breast cancer patients will be discussed [8] - Verzenio is an approved treatment for certain HR+, HER2- breast cancers and is available in multiple strengths [12][13]