Eli Lilly and Company (NYSE:LLY) is one of Goldman Sachs’s top growth stock picks. On February 18, Eli Lilly and Company (NYSE:LLY) said using Taltz (ixekizumab) together with Zepbound (tirzepatide) worked better than Taltz alone in adults who had moderate-to-severe plaque psoriasis and also had obesity or were overweight. Eli Lilly (LLY) Expands Pipeline With Positive Trial Data and New Licensing Deal Eli Lilly said the results came from its Phase 3b TOGETHER-PsO study, which tested Taltz alone vs. Talt ...

Core Insights - Eli Lilly's Zepbound (tirzepatide) has received FDA approval for a label expansion to include a four-dose single-patient use KwikPen, enhancing patient access and convenience [1][2] - Zepbound is the most prescribed injectable obesity management medication, with patients losing an average of up to 50 pounds, demonstrating strong efficacy [1][2] - The introduction of the KwikPen aims to support patients in their weight management journey, with a self-pay price starting at $299 per month [1][2] Product Details - Zepbound is available in multiple doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg, with the 2.5 mg serving as a starting dose [1][2] - The recommended maintenance doses for weight reduction are 5 mg, 10 mg, or 15 mg, administered subcutaneously once per week [1][2] - Zepbound is indicated for adults with obesity or overweight with weight-related medical problems, and it is also FDA-approved for treating moderate-to-severe obstructive sleep apnea [1][2] Clinical Efficacy - In the SURMOUNT-1 trial, participants taking Zepbound 15 mg lost an average of 20.9% of their body weight over 72 weeks, compared to 3.1% with placebo [1][2] - In the SURMOUNT-5 trial, participants on Zepbound experienced an average weight loss of 50 lbs (20.2%), while those on Wegovy lost an average of 33 lbs (13.7%) [1][2] Market Impact - In 2025, over 1 million patients accessed Lilly treatments through LillyDirect, which offers self-pay pricing at a 50% or greater discount compared to other GLP-1 medications [1][2] - One out of every three new patients starting a branded weight management medication was prescribed Zepbound self-pay vials in 2025, indicating strong market demand [1][2] Digital Health Platform - LillyDirect is a digital health platform that connects patients with chronic conditions to necessary care and prescribed medicines, facilitating prescription fulfillment through licensed healthcare providers [2][3]

Group 1: Company Performance and Developments - Eli Lilly and Company (NYSE: LLY) is recognized as a strong long-term growth stock, with Jefferies reaffirming a Buy rating and setting a price target of $1,300.00 following positive trial results for its drugs Taltz and Zepbound [1] - The TOGETHER-PsA study demonstrated that the combination of Taltz and Zepbound achieved a primary endpoint of 50% improvement in psoriatic arthritis activity and a weight drop of ≥10%, outperforming Taltz monotherapy [2] - Eli Lilly announced the acquisition of Ventyx Biosciences, a clinical-stage biopharmaceutical company, for $14.00 per share, totaling an equity value of approximately $1.2 billion [3][4] Group 2: Drug Efficacy and Market Position - The combination of Taltz and Zepbound resulted in a 64% relative increase in patients achieving ACR50 compared to Taltz alone, marking Taltz as the first biologic with comprehensive treatment data for psoriatic arthritis [2] - Eli Lilly is actively securing its position in the obesity drug market, leveraging the efficacy of its products to enhance its competitive edge [2]

Core Viewpoint - Caliway Biopharmaceuticals has submitted an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2 clinical study of CBL-514, a novel drug candidate for weight management, which aims to enhance fat reduction and improve long-term weight maintenance outcomes [1][9]. Company Overview - Caliway Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative small-molecule therapeutics, particularly in aesthetic medicine and other diseases [15]. - CBL-514 is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat without identified systematic safety risks [13]. Clinical Study Details - The Phase 2 study, named CBL-0201WR, will be randomized and placebo-controlled, enrolling approximately 120 subjects with obesity or overweight conditions [2]. - The study will evaluate the efficacy, safety, and tolerability of CBL-514 in combination with Zepbound (tirzepatide) [3][9]. - Efficacy endpoints include changes in abdominal subcutaneous fat volume measured by MRI and body weight changes, with additional assessments of body composition using DEXA [4][9]. Market Context - The global weight management market is experiencing significant growth, driven by the rapid adoption of GLP-1RA weight-loss drugs, with projections indicating it could reach approximately USD 150 billion by 2035, growing at a compound annual growth rate of around 25% [5][12]. - Current GLP-1RA therapies primarily focus on appetite suppression, which may lead to weight regain and adverse metabolic changes post-treatment, highlighting a critical challenge in weight management [6][7]. Mechanism of Action - CBL-514 operates through a distinct mechanism by selectively inducing adipocyte apoptosis and promoting fat metabolism, potentially complementing existing GLP-1RA therapies [10]. - Animal studies have shown that CBL-514 can improve fat composition and support weight maintenance, indicating its potential effectiveness in addressing unmet needs in weight management [11].

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]

Core Insights - Structure Therapeutics' shares surged 102.5% following positive top-line data from the ACCESS clinical program for aleniglipron, an investigational GLP-1 RA aimed at treating obesity and overweight patients with co-morbidities [1][3] - The 36-week phase IIb ACCESS study showed a placebo-adjusted mean weight reduction of 11.3% (27.3 lbs) at the highest 120 mg dose, meeting primary and secondary endpoints [3][4] - The ongoing ACCESS II study indicated even greater weight loss, with a 15.3% (35.5 lbs) reduction at the 240 mg dose, and sustained weight reduction observed through 44 weeks in the ACCESS OLE study [4][6] Company Developments - Structure Therapeutics plans to advance aleniglipron into phase III development, with a Type B end-of-phase 2 meeting with the FDA expected in the first half of 2026 [8][9] - The phase III study design will include a lower 2.5 mg starting dose and multiple dose levels up to 240 mg [9] - The company is also developing ANPA-0073, a phase II-ready APJR agonist for selective weight loss, alongside other obesity drug candidates in preclinical stages [10] Competitive Landscape - Eli Lilly and Novo Nordisk dominate the obesity treatment market, with their drugs Zepbound and Wegovy, respectively, experiencing stock declines following GPCR's positive results [12] - The U.S. obesity market is projected to reach $100 billion by 2030, prompting major players to optimize production and develop more effective GLP-1-based candidates [13] - Novo Nordisk is pursuing an oral version of Wegovy, while Eli Lilly is advancing several new molecules, including orforglipron and retatrutide, with regulatory applications expected soon [14][15]

Core Insights - Eli Lilly and Company will participate in Citi's 2025 Global Healthcare Conference on December 2, 2025, with Ilya Yuffa, executive vice president and president of Lilly USA, engaging in a fireside chat [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 medicine for nearly 150 years, focusing on significant health challenges such as diabetes care, obesity treatment, Alzheimer's disease, immune system disorders, and difficult-to-treat cancers [3] Company Developments - Eli Lilly announced the appointment of two new Executive Committee members and the expansion of leadership roles to prepare for future growth [5][6]

Core Viewpoint - Novo Nordisk is viewed as a speculative buy, with contrasting opinions from analysts regarding its future performance and stock potential [1][4]. Group 1: Analyst Ratings - Morgan Stanley has downgraded Novo Nordisk to underweight due to disappointing growth in key prescriptions in the U.S. [1] - HSBC Holdings has upgraded its rating to buy, citing the potential of the company's pipeline [1]. Group 2: Stock Performance - Novo Nordisk shares have experienced a nearly 50% decline, attributed to market disappointment over Wegovy's share loss in the weight loss market to Eli Lilly's Zepbound [1]. Group 3: Upcoming Events - The company is leading the race for FDA approval of an oral weight loss pill (oral Wegovy), with a decision expected this year [2]. - Novo Nordisk is conducting a phase 3 trial of its next-generation weight loss drug, CagriSema, against Eli Lilly's tirzepatide, with results expected by mid-January [2]. - Results from a phase 3 trial of semaglutide in Alzheimer's patients are anticipated in late 2025 or early 2026, aiming to slow cognitive decline [3]. Group 4: Investment Considerations - While there are no guarantees regarding the outcomes of these trials, the potential upside from the upcoming events should not be overlooked, especially if oral Wegovy receives FDA approval in 2025 [4].

Core Insights - Eli Lilly's Mounjaro (tirzepatide) demonstrated significant efficacy in treating type 2 diabetes in children and adolescents, meeting primary and secondary endpoints in the SURPASS-PEDS trial [1][2][5] - The trial results indicate a promising opportunity for improving long-term health outcomes for young patients with type 2 diabetes [2][5] Summary by Sections Trial Results - Mounjaro achieved a 2.2% reduction in A1C from a baseline of 8.05% at 30 weeks, significantly outperforming placebo [2][3] - 86.1% of participants on the 10 mg dose reached the target A1C of 6.5% [2][3] - The 10 mg dose also resulted in an average BMI reduction of 11.2% at 30 weeks, with improvements sustained through 52 weeks [2][3] Safety Profile - The safety and tolerability of Mounjaro were consistent with previous adult studies, with common adverse events including diarrhea (25%), nausea (22%), and vomiting (16%) [5] - No severe hypoglycemia episodes were reported, and the rate of Level 2 hypoglycemia was 15.4% in Mounjaro groups compared to 5.9% in placebo [5] Regulatory and Market Implications - Eli Lilly has submitted the SURPASS-PEDS results to global regulatory agencies for an expanded indication for Mounjaro [6] - The increasing prevalence of type 2 diabetes in children highlights the need for effective treatment options, positioning Mounjaro as a potential solution in an underserved market [5] Background on Mounjaro - Mounjaro is a GIP/GLP-1 dual receptor agonist that aids in glycemic control and weight management by decreasing calorie intake and improving insulin sensitivity [7][8] - It is already approved for adults with type 2 diabetes and obesity, with ongoing studies for chronic kidney disease and obesity-related morbidity/mortality [7][8]

Core Viewpoint - Inspire Medical Systems, Inc. reported disappointing second-quarter earnings and lowered its annual guidance, leading to a significant decline in its stock price [1][5]. Financial Performance - The company reported sales of $217.09 million for the second quarter, an 11% increase year-over-year, surpassing the consensus estimate of $214.48 million [1]. - Adjusted earnings per share were 45 cents, significantly higher than the consensus estimate of 21 cents [2]. - The gross margin for the second quarter was 84%, slightly down from 84.8% in the same quarter of the previous year [4]. - Operating loss was $3.3 million, a decline from an operating income of $5.1 million a year ago [4]. Guidance and Forecasts - The company revised its fiscal 2025 earnings per share guidance from a range of $2.20-$2.30 to $0.40-$0.50, compared to the consensus of $2.27 [5]. - Sales guidance for 2025 was also cut from $940 million-$955 million to $900 million-$910 million, against a consensus of $949.36 million [6]. Market Reactions - Keybanc downgraded the stock from Overweight to Sector Weight, while JPMorgan downgraded it from Overweight to Neutral, lowering the price forecast from $195 to $110 [6]. - Other firms, including Stifel, Piper Sandler, and RBC Capital, maintained their ratings but adjusted their price targets downward [7]. - The stock price of Inspire Medical Systems fell by 41.90%, reaching $76.50 at the time of publication [8].