Accessibility StatementSkip Navigation Updated results from the Phase 3 EMBER-3 trial for Inluriyoâ"¢ (imlunestrant) alone and in combination with Verzenio (abemaciclib) in ER+, HER2– metastatic breast cancer to be presented as a late-breaking oral presentation Updated safety and efficacy data to be presented from PIKALO-1, the Phase 1/2 trial of Lilly's pan-mutant- selective PI3K inhibitor, which will be advanced into the Phase 3 PIKALO-2 study New subgroup analysis from the Phase 3 monarchE trial that exp ...

Key Takeaways Roche's giredestrant showed significant invasive disease-free survival benefit in the phase III lidERA study.This is the first SERD study in the adjuvant setting to deliver a meaningful advantage over standard therapy.Positive interim data follow an earlier phase III win and support giredestrant's breast cancer programRoche (RHHBY) announced positive data from the late-stage lidERA Breast Cancer study on pipeline candidate giredestrant.Giredestrant is an investigational, oral, potent next-gene ...

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].

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]

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]

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].

Core Insights - Eli Lilly and Company announced the FDA approval of Inluriyo (imlunestrant), an oral estrogen receptor antagonist, for treating adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy [1][4][10] Group 1: Drug Efficacy and Clinical Trial Results - In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by 38% compared to endocrine therapy [1][4] - Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) with a median PFS of 5.5 months versus 3.8 months for fulvestrant or exemestane (HR=0.62, p-value=0.0008) [1][4] - The EMBER-3 trial enrolled 256 patients, with a majority receiving Inluriyo as first-line treatment after recurrence on adjuvant aromatase inhibitor therapy [4][9] Group 2: Treatment Mechanism and Administration - Inluriyo works by binding, blocking, and facilitating the degradation of overactive estrogen receptors, which can drive cancer growth [2][10] - It is administered as a once-daily oral treatment, providing a convenient option for patients [2][10] Group 3: Safety and Adverse Reactions - The majority of adverse events (AEs) associated with Inluriyo were low grade (Grade 1-2), with common reactions including decreased hemoglobin (30%), musculoskeletal pain (30%), and fatigue (23%) [5][13] - Serious adverse reactions occurred in 10% of patients, with fatal reactions reported in 1.8% of patients [12][13] Group 4: Market Impact and Future Studies - The approval of Inluriyo expands treatment options for patients with ESR1-mutated MBC, offering renewed hope and flexibility in disease management [6][5] - Inluriyo is also being studied in the ongoing Phase 3 EMBER-4 trial for early breast cancer at increased risk of recurrence, enrolling approximately 8,000 patients worldwide [6][10]