MariTide is the First Monthly or Less Frequently Dosed Peptide-Antibody Conjugate Being Investigated for the Treatment of Obesity and Type 2 Diabetes THOUSAND OAKS, Calif., June 18, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced full results from Part 1 of the Phase 2 study for MariTide (maridebart cafraglutide, formerly AMG 133) in patients living with obesity, with and without Type 2 diabetes, will be presented along with new data from the Phase 3 FOURIER study of Repatha® (evolocumab) in cardio ...

Flash | 12 Jun 2025 08:08:06 ET │ 9 pages China Pharmaceuticals Catalysts ahead: Chinese companies in ADA 2025 CITI'S TAKE The American Diabetes Association (ADA) meeting (6/20-6/23; Chicago) will happen next week, and we summarize the expected presentations from the China companies due to attend. Innovent will likely present mazdutide DREAMS-1 Ph3 study for T2D and the preclinical data for the GLP-1/GIP/GCG/PCSK9 candidate. Oral GLP-1 data including ASC30 (Ph1a), HDM1002(Ph1b) and RGT-075 (Ph2a), as well a ...

Structure Therapeutics (GPCR) FY Conference June 11, 2025 10:40 AM ET Speaker0 Following session is not open to the press. Speaker1 Perfect. Thanks, everyone, who's joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to have Ray Stevens from Structured Therapeutics here to join us. Maybe you could just start with a quick overview of the business. I would love to kind of get started there, then we'll dig in. Speaker2 Absolutely, Corinne. So Structured Therapeutics is really built arou ...

Key Takeaways NVO surged after Parvus Asset Management raised its stake to influence the CEO succession process. NVO will present positive data from STEP UP, REDEFINE 1 and 2, and amycretin trials shortly. Novo Nordisk faces extreme pressure from LLY in obesity care.Shares of Novo Nordisk (NVO) gained 5% on June 10, following a report that activist hedge fund Parvus Asset Management is building a stake in the company.Per the Financial Times, this London-based hedge fund, Parvus Asset Management, is raisin ...

Eli Lilly (LLY) FY Conference June 10, 2025 08:00 AM ET Speaker0 All right. Great. We're just about at time, so we can get started here. Welcome to good day two of our health care conference. The weather is still holding up. Thank God for that. Very pleased to kick off our morning session this morning with Eli Lilly. We have Lucas Montard, CFO and Mike Zappa, Senior Vice President, Investor Relations. Thank you, Lucas and Mike, for being with us. Happy to be here. Thank you. Great. So I guess to kick off, L ...

Core Insights - Novo Nordisk is set to present new data on its metabolic and cardiovascular health portfolio at the American Diabetes Association (ADA) 85 Scientific Sessions in June 2025, highlighting its commitment to innovation in obesity treatment and chronic disease management [1][4]. Group 1: Research and Development Highlights - A total of 29 abstracts will be presented, focusing on the weight loss efficacy of higher dose Wegovy (semaglutide 7.2 mg) for individuals with obesity and type 2 diabetes, alongside cardiovascular and kidney health benefits from various trials [2][8]. - The CagriSema REDEFINE 1 and 2 trials will showcase the first Phase 3 data on a combination of GLP-1 and amylin receptor agonists, indicating the potential of this investigational medicine [3]. - Novo Nordisk will also present data on the pipeline candidate amycretin, reinforcing its dedication to personalized healthcare solutions [3][24]. Group 2: Event Details - An R&D investor event will be hosted by Novo Nordisk on June 22, 2025, to discuss the science and abstracts presented at the congress, which will be accessible via a live webcast [4]. - The presentations will cover various trials, including the STEP UP trial on the higher dose of Wegovy and the SOUL trial analyzing the effects of oral semaglutide on cardiovascular outcomes [9][14]. Group 3: Company Vision and Strategy - The company aims to provide tailored treatment options for individuals with obesity and type 2 diabetes, emphasizing the need for personalized approaches in managing complex metabolic and cardiovascular diseases [5]. - Novo Nordisk's data presented at ADA 2025 will contribute to the evidence base supporting semaglutide as a foundational therapy for comprehensive health protection [5][20].

Arrowhead Pharmaceuticals (ARWR) FY Conference Summary Company Overview - **Company**: Arrowhead Pharmaceuticals (ARWR) - **Event**: FY Conference held on June 09, 2025 - **Key Speakers**: James Hamilton (CMO and Head of R&D), Vince Ambulone (VP of Finance and IR) Key Points Industry Context - Arrowhead is positioned in the biotechnology sector, focusing on RNA interference (RNAi) therapeutics, particularly for rare diseases and metabolic disorders [5][6][8]. Financial Health - The company has successfully augmented its balance sheet, securing funding through 2028, which allows for multiple potential independent commercial launches [7][8][66]. Product Pipeline - **Plazasiran**: - First independent commercial launch anticipated with a PDUFA date set for November 18, 2025 [5][6]. - Targeting triglyceride lowering for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG) [6][20]. - Positive data from the PALISADE Phase III study supports its efficacy [6]. - **Ongoing Studies**: - Full enrollment for Phase III studies expected by mid-2025, with completion and subsequent launch into SHTG anticipated in 2026 [7][20]. - Additional studies targeting rare muscular diseases and obesity assets are also in the pipeline, with readouts expected later in 2025 [8]. Competitive Landscape - Arrowhead acknowledges the competitive market for triglyceride-lowering therapies, particularly with Ionis Pharmaceuticals' product, Olezarsen [19][20]. - The company believes that having multiple players in the market will enhance disease state education and patient access [18][20]. Regulatory and Market Strategy - Arrowhead is confident in its communications with the FDA regarding the approval process for Plazasiran, despite the uncertainties in the biotech sector [11][12]. - The company is preparing for potential pricing strategies, considering market dynamics and the competitive landscape [22][23]. Clinical Trials and Safety - The SHASTA-5 study is designed to assess pancreatitis risk in high-risk patients, which is crucial for payer acceptance, especially in European markets [27][28][36]. - Arrowhead is focused on demonstrating a material benefit in reducing acute pancreatitis events to enhance reimbursement prospects [28][37]. Future Developments - Arrowhead is exploring combination therapies with existing GLP-1 agents to enhance weight loss outcomes and improve patient adherence [60][62]. - The company is also advancing its CNS platform, targeting ATAXN2 and tau expression, with clinical trials expected to commence within the next 6-12 months [65]. Business Development - Arrowhead plans to pursue additional partnerships and collaborations to leverage its discovery engine and expand its pipeline [66][68]. - The company is open to product and discovery partnerships, particularly in the cardiometabolic space, to support its commercialization efforts [68]. Conclusion Arrowhead Pharmaceuticals is strategically positioned for growth with a robust pipeline and a strong financial foundation. The upcoming launch of Plazasiran and ongoing studies in various therapeutic areas highlight the company's commitment to addressing unmet medical needs in the biotechnology sector. The competitive landscape and regulatory environment will be critical factors influencing Arrowhead's market success in the coming years.

Skye Bioscience (SKYE) 2025 Conference June 05, 2025 09:20 AM ET Speaker0 Morning, and welcome everyone to the Jefferies Global Healthcare Conference. I'm Jordan Carey with the investment banking team, and it's my pleasure to introduce Puneet Dillon, CEO of Sky Biosciences. Speaker1 Okay. Thank you so much. All right. Good morning, everyone. Yes, thank you again for the invitation and being here at Jefferies. It's always a pleasure seeing the entire Jefferies team and talking about what we're working on at ...

Core Insights - Regeneron Pharmaceuticals announced interim results from the Phase 2 COURAGE trial, showing that approximately 35% of weight loss from semaglutide was due to lean mass loss, and combining it with trevogrumab helped preserve lean mass while increasing fat loss [1][2][3] Group 1: Trial Results - The COURAGE trial demonstrated that combining semaglutide with trevogrumab, with or without garetosmab, preserved 50%-80% of lean mass compared to semaglutide alone while enhancing fat mass loss [1][2] - At the 26-week interim analysis, patients receiving semaglutide alone lost an average of 7.9 lbs of lean mass, while those on the lower-dose and higher-dose combinations lost 3.7 lbs and 4.2 lbs respectively, and the triplet group lost only 2.0 lbs [3][4] - Fat mass loss was significantly higher in combination groups, with the triplet group losing an average of 25.4 lbs, representing an 84.4% change from baseline [3][4] Group 2: Safety and Tolerability - The combination therapies were generally well-tolerated, but the triplet combination had a higher rate of treatment discontinuation due to tolerability issues, with 28.3% of participants discontinuing treatment [1][6] - The overall incidence of treatment-emergent adverse events (TEAEs) was 64.9% for semaglutide monotherapy, increasing to 77.2% in the triplet group [6] Group 3: Future Directions - The full data set from the COURAGE trial is expected to be available later this year, which will provide further insights for optimizing dosing regimens in future trials [2] - Regeneron is focused on developing treatments that improve the quality of weight loss by preserving muscle mass during weight reduction, addressing a significant concern in obesity management [7][8]

Industry Overview - The obesity market is rapidly expanding, driven by the success of GLP-1 therapies Wegovy and Zepbound, and is projected to reach $100 billion by 2030 [1] - There is a growing interest in cannabinoid (CBD)-based therapies as companies seek to innovate beyond GLP-1s for weight management [2] - The cannabis industry is also experiencing significant growth, expected to surpass $200 billion by 2032, although direct investments in cannabis companies have been challenging due to regulatory issues [3] Company Analysis Novo Nordisk - Novo Nordisk is a leader in obesity treatments with its semaglutide products, Wegovy and Ozempic, but faces increasing competition from Eli Lilly [5] - The company entered the CBD space by acquiring Inversago Pharmaceuticals in 2023, adding monlunabant, an investigational oral cannabinoid drug for metabolic diseases [6] - A phase IIa study on monlunabant showed statistically significant weight loss compared to placebo, but higher doses had diminishing returns; a phase IIb study is planned to find an optimal dose [7] - EPS estimates for 2025 have increased from $3.81 to $3.84, while 2026 estimates have slightly decreased from $4.66 to $4.64; the stock has declined about 21% year to date due to competition and regulatory challenges [8] Corbus Pharmaceuticals - Corbus' lead CBD candidate, CRB-913, targets the same CB1 receptor as monlunabant and is currently in phase I studies, with results expected in Q3 2025 [9] - Preclinical data suggest CRB-913 may have advantages over previous therapies, with a significantly lower brain-to-plasma ratio, indicating reduced neuropsychiatric side effects [10] - Corbus is also developing two oncology drugs, CRB-701 and CRB-601, with CRB-701 in phase I/II studies [11] - Loss per share estimates for 2025 have increased from $5.47 to $6.34, and for 2026 from $5.30 to $5.39; the stock has declined 36% year to date, reflecting regulatory volatility [12][13] Skye Bioscience - Skye Bioscience is developing nimacimab, a monoclonal antibody targeting the CB1 pathway, currently in a phase II study evaluating its efficacy as a monotherapy and in combination with Wegovy [14] - Nimacimab is designed to minimize brain penetration while maintaining metabolic effects, with early studies showing no adverse psychiatric events [15] - Loss per share estimates for 2025 have widened from $1.27 to $1.31, and for 2026 from $1.48 to $1.52; the stock has lost 27% year to date due to financial concerns and lack of commercial revenues [16]