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Ascletis Presents Full Analysis of Phase Ib Study of ASC30 Oral Tablet, Phase Ib Study of ASC30 Injection, and Preclinical Study of Combination of ASC31 and ASC47 at ObesityWeek® 2025
Prnewswire· 2025-11-05 00:10
Core Insights - Ascletis Pharma Inc. presented promising data from Phase Ib studies of its obesity treatment candidates, ASC30 and the combination of ASC31 and ASC47, at ObesityWeek 2025, highlighting their efficacy and safety profiles [4][15]. Group 1: ASC30 Oral Tablet - The Phase Ib study of ASC30 oral tablet demonstrated a placebo-adjusted mean body weight reduction of up to 6.5% after 28 days of treatment, with the highest dose (60 mg) showing a maximum reduction of 9.3% [1][8]. - The study reported mild-to-moderate gastrointestinal adverse events (AEs), with no serious adverse events (SAEs) observed across all cohorts [7][8]. - The safety profile of ASC30 was consistent with or better than that of the GLP-1R agonist class, indicating it is safe and well tolerated [8]. Group 2: ASC30 Subcutaneous Injection - The Phase Ib study of ASC30 subcutaneous injection revealed an observed half-life of 46 days for the treatment formulation and 75 days for the maintenance formulation, supporting once-monthly and once-quarterly dosing [2][10]. - Similar to the oral tablet, the subcutaneous formulations were well tolerated, with only mild-to-moderate treatment-emergent adverse events reported [11][9]. - No serious adverse events or significant safety signals were detected, reinforcing the safety of ASC30 formulations [9][10]. Group 3: Combination of ASC31 and ASC47 - The combination of ASC31 and ASC47 significantly outperformed both tirzepatide and ASC31 monotherapy in weight loss, achieving a 44.8% reduction in weight compared to 19.1% for ASC31 alone, representing a 134% greater reduction [12][13]. - The combination also demonstrated superior results in body fat loss and muscle preservation, restoring the body composition of obese mice to that of healthy non-obese mice [13]. - ASC31 is a dual GLP-1R and GIPR peptide agonist, while ASC47 is designed for targeted delivery to adipose tissue, showcasing Ascletis' innovative approach in obesity treatment [12][13].
Ardmore Shipping Q3 2025 Earnings Preview (NYSE:ASC)
Seeking Alpha· 2025-11-04 18:39
Core Points - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1] Summary by Categories Technical Requirements - Users are advised to enable Javascript and cookies in their browsers to ensure proper functionality [1] - The presence of ad-blockers can lead to blocked access, necessitating their temporary disablement [1]
Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development
Prnewswire· 2025-10-30 00:10
Core Insights - Ascletis Pharma Inc. has selected ASC36 as a clinical development candidate for obesity treatment, with an Investigational New Drug Application (IND) submission expected in Q2 2026 [3][4][7] Group 1: Drug Development and Efficacy - ASC36 is a once-monthly, subcutaneously administered amylin receptor agonist, demonstrating a half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide [1][4] - In a diet-induced obese rat study, ASC36 achieved a body weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% greater relative efficacy [5][6] - The drug's formulation allows for co-formulation with other peptides, such as ASC35, enhancing its therapeutic potential [2][7] Group 2: Technological Advancements - ASC36 was developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which facilitate the design of ultra-long-acting peptides [4][9] - The engineered properties of ASC36 support scalability advantages in manufacturing, contributing to its potential as a best-in-class treatment for obesity [5][7] Group 3: Company Strategy and Future Plans - Ascletis aims to develop ASC36 as a cornerstone therapy for cardio-metabolic diseases, with plans for combination therapies involving ASC35 [8] - A conference call is scheduled for October 30, 2025, to discuss further developments [10]
Ascletis to Present Study Results of ASC30 Oral Tablet, ASC30 Injection, and Combination of ASC31 and ASC47 at ObesityWeek® 2025
Prnewswire· 2025-10-27 10:00
Core Insights - Ascletis Pharma Inc. is presenting multiple posters on its obesity treatment programs, including ASC30, at ObesityWeek 2025 in Atlanta, Georgia, highlighting advancements in its obesity portfolio [1][2]. Group 1: Product Details - ASC30 is an investigational GLP-1 receptor biased small molecule agonist, designed for both oral and subcutaneous administration, with patent protection until 2044 [3]. - ASC31 is a novel peptide agonist targeting GLP-1R and GIPR, showing favorable pharmacokinetics and efficacy in diet-induced obese mice [4]. - ASC47 is a once-monthly subcutaneous injected small molecule agonist targeting thyroid hormone receptor beta, designed for adipose tissue targeting [5]. Group 2: Event Information - ObesityWeek 2025 will take place from November 4 to 7, 2025, featuring the latest developments in obesity research and treatment [7]. - Presentations at the event include a full analysis of a 28-day study of ASC30 and comparisons of ASC31 and ASC47 against existing treatments [2]. Group 3: Company Overview - Ascletis Pharma Inc. focuses on developing best-in-class therapeutics for metabolic diseases, utilizing proprietary technologies for drug discovery [8].
Ardmore Shipping Announces Third Quarter 2025 Conference Call and Webcast
Prnewswire· 2025-10-22 20:15
Core Insights - Ardmore Shipping Corporation plans to announce its third quarter earnings on November 5, 2025, before the market opens, followed by a conference call at 10:00 a.m. Eastern Time [1] - The company operates a fleet of MR product and chemical tankers, providing seaborne transportation of petroleum products and chemicals globally [2][3] Company Strategy - Ardmore's core strategy focuses on developing a modern, high-quality fleet, building long-term commercial relationships, and maintaining cost advantages while creating synergies and economies of scale [3] - The company provides services through voyage and time charters, maintaining close relationships with key commercial and technical management partners [3] Energy Transition Plan - Ardmore's Energy Transition Plan (ETP) emphasizes transition technologies, projects, and sustainable non-fossil fuel cargos, extending its core strengths in tanker chartering and operational efficiency [4]
Ardmore Shipping: A Compelling Buy At 0.66x NAV With Rising MR Rates (Upgrade)
Seeking Alpha· 2025-10-21 13:15
With a professional background spanning multiple industries, from logistics, construction to retail, I bring a diverse perspective to investing. My international education and career experiences have provided me with a global outlook and the ability to analyze market dynamics from different cultural and economic perspectives. I have been actively investing for over a decade, honing a strategy that focuses on cyclical industries while maintaining a diversified portfolio that includes bonds, commodities, and ...
Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
Prnewswire· 2025-10-14 10:00
Core Insights - Ascletis Pharma Inc. has successfully completed the Phase III clinical trial for denifanstat (ASC40), demonstrating significant efficacy in treating moderate-to-severe acne vulgaris compared to placebo [1][4] - The company plans to submit a New Drug Application (NDA) to the China National Medical Products Administration (NMPA) following a pre-NDA consultation [2][3] Group 1: Clinical Trial Results - Denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints in the Phase III trial, showing significant improvement in acne vulgaris [1][4] - The safety profile of denifanstat (ASC40) was favorable, with all treatment-emergent adverse events being mild or moderate, and no serious adverse events reported [4] Group 2: Regulatory and Development Plans - Ascletis has completed the pre-NDA consultation with NMPA, which began in June 2025 and concluded in October 2025, and plans to submit the NDA soon [2][3] - The results of the Phase III study were presented at the European Academy of Dermatology and Venereology Congress in September 2025 [5] Group 3: Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced drug discovery technologies [6] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6]
ASOS stock slumps as analysts warn profit gains may not offset sales weakness
Invezz· 2025-09-30 11:10
Core Viewpoint - British online fashion retailer ASOS has warned that its annual revenue will fall below market expectations due to subdued consumer demand and a slow recovery in its fast-fashion business [1] Company Summary - ASOS is experiencing a decline in annual revenue, which is attributed to weak consumer demand [1] - The company is facing challenges in the recovery of its fast-fashion segment, impacting overall performance [1] Industry Summary - The online fashion retail industry is currently facing subdued consumer demand, which is affecting revenue projections for companies like ASOS [1] - The slow recovery in the fast-fashion business indicates broader challenges within the industry, potentially influencing market dynamics [1]
Ascletis Announces ASC47 in Combination with Semaglutide Demonstrated Up to 56.2% Greater Relative Reduction in Body Weight in Participants with Obesity Compared to Semaglutide Monotherapy
Prnewswire· 2025-09-22 00:10
Core Insights - The gastrointestinal tolerability of ASC47 in combination with semaglutide is significantly better than that of semaglutide monotherapy, indicating a potential advantage for ASC47 in clinical applications [1] Group 1 - The incidence of vomiting in the ASC47 plus semaglutide group was 6.7%, compared to 57.1% in the semaglutide monotherapy group, highlighting a substantial difference in tolerability [1]
Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025
Prnewswire· 2025-09-17 23:30
Core Insights - Denifanstat (ASC40) has met all primary, key secondary, and secondary efficacy endpoints in treating moderate-to-severe acne compared to placebo [1][6][11] - The drug demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [1][9] Efficacy Results - The Phase III clinical trial involved 480 patients, randomized into treatment and placebo groups, showing significant improvements in multiple efficacy endpoints after 4 weeks and 12 weeks of treatment [4][6] - Primary endpoints included a treatment success rate of 33.17% for denifanstat compared to 14.58% for placebo, with a p-value of <0.0001 [5][6] - Percent reductions from baseline to week 12 in total lesion count (TLC) and inflammatory lesion count (ILC) were 57.38% and 63.45% for denifanstat, respectively, both statistically significant [6][7] Safety Profile - The incidence of TEAEs was 58.6% for denifanstat and 56.3% for placebo, with most events being mild or moderate [9] - Notable TEAEs included 6.3% dry skin and 5.9% xerophthalmia in the denifanstat group, with no serious adverse events reported [9] Regulatory Progress - Ongoing pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) has yielded encouraging feedback, with plans to submit an NDA for denifanstat after consultation completion [2][11] Company Background - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced drug discovery platforms [13]