Inluriyo (imlunestrant)
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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
Group 1 - Eli Lilly and Company is identified as one of the best growth stocks to buy in 2026, with a price target adjustment from Bank of America to $1,268 from $1,286 while maintaining a Buy rating [1] - The company's bullish outlook is attributed to successful obesity product launches and the expansion of its pipeline into new therapeutic areas, with projected earnings for 2027 expected to reflect long-term growth potential [1][3] - Updated results from the Phase 3 EMBER-3 study for Inluriyo (imlunestrant) demonstrate its efficacy as a standalone treatment and in combination with Verzenio (abemaciclib) for patients with ER+, HER2- advanced or metastatic breast cancer [2][3] Group 2 - In patients with ESR1-mutated disease, imlunestrant monotherapy showed a clinically meaningful 38% reduction in the risk of progression or death, while the combination with abemaciclib yielded even more robust results [3] - Safety profiles for imlunestrant remained consistent with previous reports, with no new safety signals identified during an additional year of follow-up [3] - Eli Lilly has submitted combination data for US regulatory review in ESR1-mutated metastatic breast cancer and is conducting the EMBER-4 trial with approximately 8,000 patients to explore its potential in the adjuvant setting for early breast cancer [4]
Eli Lilly and Company (LLY) Announces Updated Meaningful Data on Breast Cancer Treatment
Yahoo Finance· 2025-12-22 13:39
Core Insights - Eli Lilly and Company (NYSE: LLY) is recognized as a strong investment opportunity by hedge funds, with Goldman Sachs raising its price target from $951 to $1,145 while maintaining a Buy rating [1] Group 1: Breast Cancer Treatment Developments - Eli Lilly provided updated data on its oral estrogen receptor antagonist Inluriyo (imlunestrant), showing a 38% reduction in the risk of progression or death in patients with advanced or metastatic breast cancer [2] - The updated results indicate a median progression-free survival of 11 months and are consistent with previous efficacy results, demonstrating durable benefits across efficacy endpoints [2] Group 2: FDA Approval and Treatment Benefits - Following the FDA approval of Inluriyo as a monotherapy, the updated data reinforces its clinically meaningful benefits for both monotherapy and combination therapy with abemaciclib [3] Group 3: Pricing Strategy for Zepbound - Eli Lilly announced plans to offer single-dose vials of Zepbound (tirzepatide) at reduced prices, with discounts ranging from $50 to $100 based on dosage, in response to the need for lower prices for GLP-1 medications [4] Group 4: Company Overview - Eli Lilly is a major global pharmaceutical company focused on discovering, developing, manufacturing, and selling human medicines and animal health products, particularly in the diabetes sector [5]
Eli Lilly and Company (LLY) Releases Updated Results from Phase 3 EMBER-3 Study of Inluriyo (imlunestrant)
Yahoo Finance· 2025-12-21 15:44
Group 1 - Eli Lilly and Company (NYSE: LLY) is recognized as one of the best stocks to invest in for the next three years, particularly following the updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant) for advanced or metastatic breast cancer [1] - The updated data from the EMBER-3 study show continued clinically meaningful benefits for patients receiving Inluriyo as monotherapy and in combination with abemaciclib, reinforcing its role in treatment [2] - The results for the combination therapy were consistent with previous efficacy results and demonstrated durable benefits across efficacy endpoints, regardless of ESR1 mutation status [2] Group 2 - Eli Lilly announced plans to invest over $6 billion in a new manufacturing facility in Huntsville, Alabama, aimed at producing small molecule synthetic and peptide medicines [3] - The new facility will manufacture orforglipron, Eli Lilly's first oral small molecule GLP-1 receptor agonist, which is expected to be submitted to global regulatory agencies for obesity by the end of the year [4]
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]
RHHBY Reports Positive Phase III Data on Breast Cancer Drug
ZACKS· 2025-11-18 19:26
Core Insights - Roche (RHHBY) announced positive interim results from the late-stage lidERA Breast Cancer study for giredestrant, a next-generation selective estrogen receptor degrader (SERD) [1][4] - Giredestrant showed a statistically significant and clinically meaningful benefit over standard endocrine therapy in patients with ER-positive, HER2-negative breast cancer [5][8] Study Details - The lidERA study is a phase III, randomized, open-label trial involving approximately 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative breast cancer [2][3] - The primary endpoint is invasive disease-free survival (iDFS), with key secondary endpoints including overall survival and safety [3] Results and Implications - The study met its primary endpoint, demonstrating a significant improvement in iDFS with giredestrant compared to standard therapy, marking it as the first SERD trial to show such benefit in the adjuvant setting [4][8] - Although overall survival data were immature at the interim analysis, a positive trend was observed, indicating giredestrant's potential as a new treatment option for early-stage breast cancer patients [5] Roche's Breast Cancer Franchise - Roche's breast cancer portfolio includes Herceptin, Perjeta, and Kadcyla, with Kadcyla performing well due to increased demand from patients with residual disease [7] - The approval of the fixed-dose combination of Perjeta and Herceptin as Phesgo has further strengthened Roche's position in the market [7] - Roche's shares have increased by 27.8% year-to-date, outperforming the industry growth of 14.3% [7] Future Developments - Roche is conducting an extensive clinical development program for giredestrant across five phase III trials in various treatment settings [10] - The approval of inavolisib for breast cancer treatment has also bolstered Roche's franchise, indicating ongoing innovation in their product offerings [9]
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].
Guggenheim Reaffirms Its Buy Rating on Eli Lilly & Company (LLY) with Price Target of $875
Yahoo Finance· 2025-10-08 14:02
Core Insights - Eli Lilly & Company (NYSE: LLY) is recognized as one of the best non-tech stocks to buy, supported by hedge fund interest [1] - Guggenheim has reaffirmed its Buy rating on Eli Lilly with a price target of $875 [2] - Strong demand for tirzepatide in diabetes and obesity treatment, along with the upcoming launch of orforglipron, is expected to drive global growth [3] Financial Performance - Eli Lilly reported a gross profit margin of 82.64% and a revenue increase of 36.83% year-over-year [3] Regulatory Developments - The U.S. FDA authorized Guardant Health's Guardant360 CDx as a companion diagnostic for Eli Lilly's breast cancer medication Inluriyo, aiding in the identification of patients with advanced breast cancer and ESR1 mutations [4] Market Position - Eli Lilly's advancements in the metabolic and oncology sectors, combined with analyst confidence and regulatory approvals, reinforce its status as a leading global pharmaceutical company [5]
LLY Gets EU Approval for Alzheimer's Drug & FDA Nod to Cancer Therapy
ZACKS· 2025-09-26 15:35
Core Insights - Eli Lilly and Company (LLY) received marketing authorization from the European Commission for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease (AD) [1][7] - Kisunla is approved for adults with mild cognitive impairment (MCI) and mild dementia stage of AD with confirmed amyloid pathology [1][9] - The approval is supported by data from two late-stage studies, TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6, demonstrating significant slowing of cognitive and functional decline [2][9] Company Performance - Year to date, Eli Lilly's shares have declined by 7.4%, while the industry has seen a decrease of only 0.5% [4] Market Context - Kisunla is part of a competitive landscape in the AD treatment space, alongside Biogen/Eisai's Leqembi, which also targets early symptomatic AD [8][9] - Both drugs aim to reduce amyloid beta (Aβ) plaque accumulation, a key factor in cognitive decline associated with AD [9][10] - Kisunla has shown rapid uptake, recording sales of $70.1 million in the first half of 2025 [10]
Lilly opens newest Gateway Labs site in San Diego to boost local biotechnology ecosystem
Prnewswire· 2025-09-26 12:30
Core Insights - Eli Lilly and Company has officially opened its newest Lilly Gateway Labs (LGL) site in San Diego, California, aimed at supporting early-stage biotechnology companies by providing lab space and collaboration opportunities with Lilly scientists [1][2]. Group 1: Facility and Operations - The new facility spans 82,514 square feet and can accommodate up to 15 life sciences companies, employing over 250 individuals from LGL-based companies [2]. - The San Diego site is part of a broader network of innovation hubs, with existing locations in South San Francisco and Boston, and a newly opened site in Beijing [2][4]. Group 2: Strategic Goals and Collaboration - Lilly's commitment to the biotech ecosystem is highlighted by its approach to support companies at every stage of development, emphasizing collaboration with academia, biotech, and large pharmaceutical companies [2][3]. - The Gateway Labs model provides startups with access to wet lab facilities, tailored scientific engagement, and strategic guidance to navigate drug discovery complexities [2][3]. Group 3: Financial Impact and Growth - Since the inception of the first Gateway Labs site in 2019, companies within the program have raised over $2 billion in capital, facilitating the development of more than 50 therapeutics and platforms [2][5]. - The model has demonstrated sustained growth through a high-touch partnership approach, focusing on helping biotech companies avoid common pitfalls [3].