Eli Lilly (LLY) and partner Incyte (INCY) announced that a late-stage study evaluating oral baricitinib in adolescent patients (aged 12-18) with severe alopecia areata (AA) showed clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36.The phase III BRAVE-AA-PEDS study enrolled 257 patients who were randomized to receive either a dose of baricitinib (4 mg or 2 mg) or placebo. AA is an immune system disorder that leads to patchy hair loss on the scalp, face, and oc ...

Core Insights - Eli Lilly and Incyte presented late-breaking results showing that 42.4% of adolescents treated with baricitinib 4 mg achieved 80% or more scalp hair coverage at Week 36, indicating significant hair regrowth potential for severe alopecia areata [1][2][3] - The Phase 3 BRAVE-AA-PEDS study demonstrated that baricitinib can provide clinically meaningful improvements in hair regrowth for adolescents, with results comparable to those seen in adults after a longer treatment duration [2][3] - Baricitinib is positioned as a leading treatment option for severe alopecia areata, with ongoing studies expected to provide further data and regulatory discussions in the near future [2][5] Study Results - In the BRAVE-AA-PEDS study, 257 patients were randomized to receive either baricitinib 4 mg, 2 mg, or placebo, with the primary endpoint being a SALT score of ≤20 at Week 36 [1][7] - At Week 36, 60.0% of patients on baricitinib 4 mg and 36.9% on 2 mg saw at least a 50% improvement in their disease, compared to only 5.7% on placebo [3] - Significant eyebrow and eyelash regrowth was also observed, with 50.0% and 42.9% of patients on baricitinib 4 mg achieving notable improvements, respectively [3] Safety Profile - The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections, with a higher frequency of serious adverse events in the placebo group [4] - The safety profile of baricitinib in adolescents aligns with previous findings in trials for juvenile idiopathic arthritis and atopic dermatitis, indicating a consistent safety record [4][5] Regulatory and Market Position - Baricitinib, marketed as Olumiant, is already approved for adult patients with severe alopecia areata and has received regulatory approval for other conditions, including rheumatoid arthritis and atopic dermatitis [5][6] - The company plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings and submit results for peer-reviewed publication, reinforcing its commitment to advancing treatment options for alopecia areata [5][6]

Among EBGLYSS Week 16 responders from the monotherapy trials, 50% achieved highest bar of complete skin clearance (EASI 100 or IGA 0) and 87% achieved almost-clear skin (EASI 90) at three years with single monthly maintenance injection Additional studies demonstrated EBGLYSS significantly improved itch, skin pain, and sleep loss due to itch for a range of patients with atopic dermatitis EBGLYSS was approved in the U.S. in September 2024 as a first-line monotherapy biologic treatment option following topical ...

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Core Viewpoint - Companies are increasingly investing in the United States to mitigate the negative impacts of tariffs, with Eli Lilly and Company announcing a $27 billion investment to enhance its manufacturing capabilities [1][4]. Company Investment Strategy - Eli Lilly plans to invest an additional $27 billion in the U.S. over the next five years, bringing its total U.S. manufacturing investment to $50 billion since 2020 [4]. - The investment will include the construction of four new manufacturing facilities aimed at increasing production across various therapeutic areas, including active ingredients and injectable pens for specific medications [4][5]. Market Reaction - Following the announcement, Eli Lilly's shares rose approximately 2%, indicating moderate market support for the investment decision [6]. - The investment is seen as a strategic response to tariff uncertainties, particularly in light of potential 25% tariffs on imported pharmaceuticals [5]. Economic Context - The S&P 500 Index has declined over 3% since the onset of tariff discussions, reflecting market concerns about inflation and economic growth [2][3]. - The University of Michigan Consumer Sentiment Index has dropped to its lowest level since November 2023, indicating weakening consumer confidence [2]. Supply Chain and Demand Management - Eli Lilly's investment aims to prevent future shortages of its popular drugs, such as Mounjaro and Zepbound, by increasing manufacturing capacity [7]. - The company has recently resolved a shortage of tirzepatide, the main ingredient in these medications, which is crucial for maintaining sales growth [7]. Valuation and Analyst Sentiment - Despite a high valuation, Eli Lilly's investment strategy and market positioning enhance its appeal, with analysts projecting a 32.54% earnings growth [7]. - Analysts at TD Cowen have raised the price target for Eli Lilly to $1,050, suggesting a 15% upside from the recent closing price [12].

Core Insights - Eli Lilly is focusing on key upcoming pipeline catalysts, particularly in the oncology sector and broader R&D initiatives [4]. Group 1: Pipeline Developments - The orforglipron program is highlighted as a significant upcoming catalyst, which is an oral small molecule GLP-1 nonpeptide agonist [5]. - The first study of the orforglipron program will focus on type 2 diabetes, while the second will target obesity [5]. - The ability to manufacture this oral small molecule at scale is emphasized as a critical advantage for the company [6].

Core Viewpoint - Eli Lilly's BTK inhibitor, Jaypirca, has received a positive opinion from the European Medicines Agency's CHMP for treating relapsed or refractory chronic lymphocytic leukemia (CLL) in previously treated patients, with the decision expected from the European Commission in a couple of months [1][2]. Group 1: Regulatory Approvals - Jaypirca is already conditionally approved in the EU for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a BTK inhibitor [2]. - The approval for CLL is based on data from the phase III BRUIN CLL-321 study [1]. Group 2: Sales Performance - Jaypirca recorded $337.0 million in sales in 2024, contributing to Eli Lilly's top-line growth [5]. - The drug is also being studied for earlier lines of therapy to expand its use for CLL and MCL indications [5]. Group 3: Market Competition - Current BTK inhibitors for CLL include AbbVie/J&J's Imbruvica, AstraZeneca's Calquence, and BeiGene's Brukinsa, with Imbruvica experiencing declining sales due to rising competition [6]. - None of the existing BTK inhibitors are approved for relapsed or refractory CLL in the post-BTK inhibitor setting [6]. Group 4: Stock Performance - Eli Lilly's shares have increased by 16.2% over the past year, contrasting with a 0.9% decline in the industry [3].

Core Points - Eli Lilly and Company will participate in the Leerink Partners Global Healthcare Conference on March 10, 2025, with CFO Lucas Montarce scheduled for a fireside chat at 9:20 a.m. Eastern time [1] - A live audio webcast of the presentation will be available on Lilly's investor website, with a replay accessible for approximately 90 days [2] - Lilly has been a pioneer in medical discoveries for nearly 150 years, focusing on various health challenges including diabetes care, obesity treatment, Alzheimer's disease, immune system disorders, and difficult-to-treat cancers [3] Company Overview - Eli Lilly is dedicated to turning scientific advancements into healing solutions, aiming to improve the lives of millions globally [3] - The company emphasizes the importance of innovative clinical trials that reflect global diversity and strives to ensure the accessibility and affordability of its medicines [3]

Core Opinion - The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Jaypirca (pirtobrutinib) for treating adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated with a BTK inhibitor [1][2][5] Clinical Trial Results - The BRUIN CLL-321 trial is the first randomized Phase 3 study in CLL conducted exclusively in patients previously treated with a BTK inhibitor [1][3] - The primary endpoint of progression-free survival (PFS) was met, showing pirtobrutinib was superior to the standard care options, reducing the risk of disease progression or death by 46% (median PFS: 14.0 months vs. 8.7 months) [3][7] - The median time to next treatment or death (TTNT) was 24 months for pirtobrutinib compared to 11 months for the control arm, indicating a 63% improvement [3][7] Safety Profile - The overall safety profile of pirtobrutinib was consistent with previous studies, with common adverse reactions including neutropenia, fatigue, diarrhea, anemia, rash, and contusion [3][18] - Serious adverse reactions occurred in 56% of patients with CLL, with pneumonia (18%) and COVID-19 (9%) being the most common [24][26] Regulatory Status - Following the positive opinion, the application for Jaypirca is now referred to the European Commission for final action, with a decision expected in one to two months [2][5] - Jaypirca has also received conditional marketing authorization in the EU for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) previously treated with a BTK inhibitor [2][5] Market Context - There are currently no treatment options specifically studied in a randomized Phase 3 trial for patients with relapsed or refractory CLL in the post-BTK inhibitor setting, highlighting the unmet need in this area [2][5] - Jaypirca was approved in the U.S. in 2023 under the FDA's Accelerated Approval pathway for similar indications, indicating a growing market for targeted therapies in hematologic malignancies [5][6]

Group 1: Investment and Manufacturing Expansion - Eli Lilly is investing an additional $27 billion to enhance domestic drug production, bringing its total U.S. manufacturing investment to over $50 billion since 2020 [1][2] - The company plans to build four new pharmaceutical manufacturing sites, with three focusing on active pharmaceutical ingredients to strengthen its supply chain [2] - The investment will create 3,000 jobs for skilled workers and support 10,000 construction jobs [5] Group 2: Strategic Vision and Market Position - Eli Lilly's CEO, David Ricks, expressed optimism about the company's pipeline across various therapeutic areas, which drives the commitment to domestic manufacturing [4] - The investment reflects the company's strategy to meet anticipated demand for safe, high-quality, FDA-approved medicines in the future [5] Group 3: Industry Context - The announcement comes amid U.S. plans to impose tariffs on Canada and Mexico, which may impact the broader manufacturing landscape [7][8] - Eli Lilly's investment aligns with a trend of companies committing to U.S. manufacturing under the current administration, with Apple also announcing a significant $500 billion investment [9]