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Ascletis Pharma Advances in Obesity Treatment with ASC37 Development
Financial Modeling Prep· 2025-12-01 00:00
Ascletis Pharma Inc., listed on the Hong Kong Stock Exchange, is a leading biotechnology company focused on the development and commercialization of innovative treatments for metabolic diseases. The company has recently made a significant breakthrough by selecting ASC37, its first oral GLP-1R/GIPR/GCGR triple peptide agonist, for clinical development, aiming to address the growing needs in obesity treatment.Key Insights:ASC37, developed with Ascletis' proprietary Peptide Oral Transport ENhancement Technolog ...
Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development
Prnewswire· 2025-11-30 10:15
Core Viewpoint - Ascletis Pharma Inc. has selected ASC37 oral tablets as a clinical development candidate for obesity treatment, leveraging its proprietary Peptide Oral Transport ENhancement Technology (POTENT) to achieve significantly higher oral bioavailability compared to existing treatments [4][5][6]. Group 1: Product Development - ASC37 oral tablets achieved an average absolute oral bioavailability of 4.2%, which is approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide, respectively, in head-to-head non-human primate (NHP) studies [6]. - The drug exposure of ASC37, measured by the area under the curve (AUC), was approximately 57-fold greater than that of retatrutide in NHP studies [2][6]. - The average observed half-life of ASC37 oral tablets was approximately 56 hours, supporting once daily and less frequent oral dosing [2][7]. Group 2: Clinical Development Timeline - The company plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets in the second quarter of 2026 [3][4]. - A conference call will be hosted by the company in Mandarin on December 1, 2025, to discuss further developments [3][9]. Group 3: Technological Innovation - ASC37 is developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and is a GLP-1R, GIPR, and GCGR triple peptide agonist, demonstrating in vitro activity that is approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR, and GCGR, respectively [5][8]. - The selection of ASC37 for clinical development highlights the company's strong R&D capabilities and commitment to addressing unmet needs in obesity treatment [8]. Group 4: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary technologies including AISBDD and POTENT [10]. - The company has developed multiple drug candidates, including ASC30, ASC36, ASC35, and ASC37, targeting chronic weight management [10].
Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management
Prnewswire· 2025-11-27 08:49
Core Insights - Gan & Lee Pharmaceuticals has initiated the GRADUAL-3 phase 3 clinical study for its GLP-1 receptor agonist, bofanglutide, targeting adults with obesity or overweight [1][3] - The study aims to evaluate the efficacy and safety of once-monthly bofanglutide injection over a 24-week period [2][7] - Previous studies, GRADUAL-1 and GRADUAL-2, have established the groundwork for assessing bofanglutide's effectiveness in weight management [3][7] Study Design and Objectives - GRADUAL-3 is designed to explore the potential of bofanglutide to maintain weight loss and improve long-term adherence by administering the injection subcutaneously once every four weeks [1][4] - The primary endpoints of the study include changes in body weight and percentage change from baseline at Week 24 [2][7] - The study is part of a broader GRADUAL clinical development program, which includes three large-scale phase 3 studies with over 1,000 participants planned for enrollment [4] Previous Clinical Studies - GRADUAL-1 involved approximately 630 Chinese adults and assessed the weight-loss efficacy and safety of bofanglutide over 52 weeks [7] - GRADUAL-2 included around 471 participants and compared bofanglutide with semaglutide (Wegovy) in a head-to-head study [3][7] - Both previous studies aimed to confirm the efficacy and safety of bofanglutide in managing obesity and its impact on metabolic parameters [3][5] Product Overview - Bofanglutide (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee, focusing on obesity/overweight and type 2 diabetes indications [5] - Clinical studies have shown that bofanglutide provides significant weight-loss and glucose-lowering effects, with a safety profile consistent with existing GLP-1 RAs [5]
Safe Supply Secures Exclusive Canadian Rights to Healthy Sprays' Proprietary GLP-1 Delivery Technology; Announces Non-Brokered Private Placement
Newsfile· 2025-11-24 14:05
Toronto, Ontario--(Newsfile Corp. - November 24, 2025) - Safe Supply Streaming Co Ltd. (CSE: SPLY) (OTCQB: SSPLF) (FSE: QM4) ("Safe Supply" or the "Company"), a pioneer in the health, safety and rapid response technologies, is pleased to announce it has entered into an Exclusive Territory License and Commercial Agreement (the "Licensing Agreement") with Healthy Sprays LLC ("Healthy Sprays"), granting Safe Supply the exclusive Canadian rights to distribute the full Healthy Sprays portfolio of innovative GLP ...
Novo Nordisk Just Took a Big Swing, Slashing Its GLP-1 Drug Prices. Will It Pay Off for the Healthcare Giant?
The Motley Fool· 2025-11-23 09:30
Core Insights - The obesity drug market, particularly GLP-1 agonist weight-loss drugs, is emerging as a significant growth opportunity in the pharmaceutical industry, transitioning from a trend to a major market player [1] - Novo Nordisk is responding to competitive pressures by implementing aggressive pricing strategies to regain market share, particularly against Eli Lilly and telehealth companies [3][8] Company Overview - Novo Nordisk has faced challenges over the past 18 months, with share prices dropping by two-thirds, but is now taking steps to recover after a CEO change [3] - The company is reducing prices for its drugs Ozempic and Wegovy, with self-paying patients now paying $349 per month, down from $499, to align with competitors [8][12] Competitive Landscape - Eli Lilly's Mounjaro and Zepbound have gained significant market traction, leading to faster revenue growth compared to Novo Nordisk [6] - Telehealth companies like Hims & Hers Health have been selling compounded semaglutide at lower prices, further intensifying competition [9][11] Pricing Strategy - Novo Nordisk's new pricing plan aims to make its FDA-approved drugs more accessible, potentially reducing the appeal of compounded alternatives [12][15] - The company is also preparing for the launch of a Wegovy pill, which could attract more patients preferring oral medication over injections [13][14] Market Potential - The obesity drug market is projected to reach $150 billion by 2035, highlighting the significant growth potential for companies in this sector [3]
Beyond GLP-1: Eli Lilly's Expanding Drug Portfolio Lifts Sales
ZACKS· 2025-11-20 13:06
Core Insights - Eli Lilly and Company's stock reached $1000 per share for the first time on November 12, indicating strong market performance and nearing a $1 trillion market cap, primarily driven by the success of GLP-1 drugs like Mounjaro and Zepbound [1][8] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh, Jaypirca, Ebglyss, and Kisunla, which are contributing to revenue growth alongside GLP-1 drugs [2][5] - In the first nine months of 2025, Omvoh generated $176.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $274.1 million, $140.6 million, and $358.2 million, respectively, totaling $950 million from these new drugs [3][10] Ongoing Studies and Future Potential - New drugs are being evaluated for additional indications, with Ebglyss in phase III trials for chronic rhinosinusitis and Jaypirca being studied for broader use in CLL and MCL [4][8] - Lilly anticipates launching new drugs in the fourth quarter of 2025 and throughout 2026, which will further enhance revenue [5][8] M&A Strategy - To diversify its portfolio beyond GLP-1 drugs, Lilly is pursuing M&A opportunities in cardiovascular, oncology, and neuroscience sectors, including the acquisition of Verve Therapeutics and Adverum Biotechnologies [6][7] Competitive Landscape - Omvoh faces competition from AbbVie’s and J&J’s products, while Kisunla competes with Eisai/Biogen's Leqembi, and Jaypirca competes with older BTK inhibitors [9][11] Stock Performance and Valuation - Lilly's stock has increased by 35.8% this year, outperforming the industry average of 14.4% [12] - The stock trades at a price/earnings ratio of 33.83, significantly higher than the industry average of 16.84, but below its 5-year mean of 34.54 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has risen from $22.94 to $23.78, and for 2026 from $30.79 to $32.06 over the past 30 days [16]
Researchers move closer to matching patients with GLP-1 drug that works best for them
Reuters· 2025-11-19 22:59
U.S. researchers are beginning to identify clinical characteristics that distinguish "super responders†to GLP-1 weight-loss drugs like Wegovy and Zepbound from patients who lose only moderate amounts of weight at best, according to a report published online ahead of peer review. ...
SureNano Announces Non-Binding Letter of Intent to Negotiate Proposed Transaction of GlucaPharm Inc. for GLP-1 Drug Development
Newsfile· 2025-11-19 21:30
SureNano Announces Non-Binding Letter of Intent to Negotiate Proposed Transaction of GlucaPharm Inc. for GLP-1 Drug DevelopmentNovember 19, 2025 4:30 PM EST | Source: SureNano Science Ltd.Vancouver, British Columbia--(Newsfile Corp. - November 19, 2025) - SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) (the "Company" or "SureNano") is pleased to announce it has entered into a non-binding letter of intent (the "LOI") with GlucaPharm Inc. ("GlucaPharm"), to conduct legal, technical and financia ...
Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting
Prnewswire· 2025-11-17 23:37
Core Insights - Vanda Pharmaceuticals has announced positive topline results from a clinical study of tradipitant, indicating its potential as a key adjunct in the over $50 billion global GLP-1 agonist market [1][4]. Study Results - The study showed that only 29.3% of participants treated with tradipitant experienced vomiting compared to 58.6% in the placebo group, achieving a 50% relative reduction (p=0.0016) [2][4]. - The secondary endpoint was also met, with 22.4% of the tradipitant group experiencing vomiting and significant nausea, versus 48.3% in the placebo group (p=0.0039) [2][4]. Safety Profile - Tradipitant exhibited a favorable safety profile, consistent with previous studies, with no new safety signals reported [3][4]. Market Implications - The efficacy of tradipitant in reducing nausea and vomiting could significantly improve adherence to GLP-1 agonist treatments, which currently face a 30-50% discontinuation rate due to gastrointestinal side effects [5][6]. - The global GLP-1 agonist market is projected to exceed $50 billion, highlighting the potential financial impact of tradipitant's success [4][5]. Future Development - Vanda plans to initiate a Phase III program for tradipitant in the first half of 2026, aiming for regulatory approval to address the unmet need in managing GLP-1 induced nausea and vomiting [7][9].
Global Partners (GLP) Dips Following Q3 Results
Yahoo Finance· 2025-11-12 02:45
The share price of Global Partners LP (NYSE:GLP) fell by 9.14% between November 3 and November 10, 2025, putting it among the Energy Stocks that Lost the Most This Week. Global Partners (GLP) Dips Following Q3 Results Global Partners LP (NYSE:GLP) is a leading independent owner, supplier, and operator of liquid energy terminals, fueling locations, and retail experiences. Global Partners LP (NYSE:GLP) reported lower-than-expected profits in its third quarter results posted on November 7, with the company ...