Key Takeaways Novo Nordisk will acquire Akero Therapeutics for $4.7B plus a contingent $6 per share payment.The deal gives NVO access to Akero's EFX, a late-stage FGF21 analog for MASH with fibrosis regression data.The acquisition advances NVO's goal to broaden its cardiometabolic portfolio beyond semaglutide therapies.Novo Nordisk (NVO) continues to derive the bulk of its revenue from its blockbuster semaglutide (GLP-1 RA) therapies, Wegovy for obesity and Ozempic for type II diabetes (T2D). Together, the ...

By Maggie Fick and Mariam Sunny (Reuters) -Novo Nordisk said on Thursday it would buy U.S.-based Akero Therapeutics for up to $5.2 billion to gain access to a promising liver disease drug candidate, in the first major deal by the Danish drugmaker's new CEO to spur growth. Mike Doustdar, who took the helm at the Wegovy maker in July, has signaled a focus on new, highly effective obesity and diabetes drugs that can also treat related cardiometabolic conditions such as MASH, rather than expanding into other ...

RAFAEL VALVERDE Rafael lives with obesity Mexico Novo Nordisk – a focused healthcare company Novo Nordisk to acquire Akero Therapeutics Inc. 2 Investor presentation 9 October 2025 Forward-looking statements Novo Nordisk's statutory Annual Report 2024, Form 20-F, any quarterly financial reports, investor presentations and written information released, shown, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain certain forward-looking statements relating to the ope ...

Skye Bioscience Inc. (NASDAQ:SKYE) stock sank on Monday after the company released topline data from its 26-week Phase 2a CBeyond proof-of-concept study of nimacimab.The nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo (-1.52% vs. -0.26 for placebo, mITT).Preliminary pharmacokinetic analysis showed lower than expected drug exposure of nimacimab, supporting evaluation of higher dosing.Also Read: Skye Bioscience Advances Position In Competitive Obesity Market W ...

Summary of Skye Bioscience Conference Call on Phase IIa Clinical Trial Results Company Overview - **Company**: Skye Bioscience (NasdaqGM:SKYE) - **Focus**: Development of Nimasumab for obesity treatment Key Industry Insights - **Clinical Trial**: Phase IIa CBON clinical trial results for Nimasumab - **Primary Endpoint**: Weight loss compared to placebo Core Findings 1. **Monotherapy Results**: - The 200 mg monotherapy arm did not meet the primary endpoint compared to placebo - Weight loss: -1.5% for Nimasumab vs -0.3% for placebo in the modified intent to treat population [8][34] - Lower than expected drug exposure was identified as a reason for this outcome [8][9] 2. **Combination Therapy Results**: - Combination of Nimasumab and Semaglutide showed a clinically meaningful weight loss of approximately -14.3% at 26 weeks compared to -10.8% for Semaglutide alone [13][35] - 100% of participants in the combination arm achieved at least 5% weight loss, and two-thirds achieved at least 10% [14][35] 3. **Safety Profile**: - Nimasumab demonstrated a favorable safety and tolerability profile, with adverse events similar to placebo [16][52] - No neuropsychiatric adverse events were reported, which is a significant differentiator from previous CB1 approaches [17][19] 4. **Pharmacokinetics (PK) Insights**: - Preliminary PK analysis indicated that many participants had lower than predicted drug exposure [41][43] - Higher dosing is suggested as a logical next step to improve efficacy [11][12] 5. **Future Directions**: - Plans to test higher doses (600 mg to 1000 mg) in future trials to explore efficacy further [72][73] - Ongoing extension study evaluating a 300 mg dose to gather additional PK and efficacy data [62][64] Additional Considerations - **Mechanistic Insights**: The combination of Nimasumab and Semaglutide works through complementary mechanisms, enhancing weight loss without increasing gastrointestinal side effects [15][60] - **Body Composition**: The combination therapy showed a favorable lean to fat mass ratio improvement compared to Semaglutide alone [39][61] - **Market Positioning**: Nimasumab is positioned as a complementary treatment in the obesity landscape, particularly against GLP-1s, which have GI burden challenges [21][60] Conclusion - The results from the Phase IIa trial provide valuable insights into the efficacy and safety of Nimasumab, highlighting the need for further exploration of dosing strategies to optimize therapeutic outcomes in obesity treatment. The combination therapy shows promise in enhancing weight loss while maintaining a favorable safety profile.

Summary of Altimmune Conference Call Company Overview - **Company**: Altimmune - **Product**: GLP-1/glucagon dual agonist for MASH (Metabolic Associated Steatotic Liver Disease) and weight loss Key Points Product Development and Efficacy - Altimmune is developing a GLP-1/glucagon dual agonist that targets liver effects and metabolic benefits, showing promising results in a 24-week Phase 2 trial with class-leading MASH resolution and significant weight loss of approximately 6% at 24 weeks [2][3][20] - The drug demonstrated excellent tolerability without dose titration, which is crucial for patient adherence [3][12] - The treatment shows rapid effects on liver health and weight loss, with expectations of continued improvement as treatment progresses [20][23] Regulatory Considerations - The company is preparing for potential FDA approval based on MASH resolution endpoints, with a focus on both traditional biopsy-based and non-invasive tests (NITs) [11][25] - AI-enabled histological assessments for fibrosis are being considered, with positive feedback expected from the FDA in Q4 [8][9][25] - Altimmune plans to incorporate flexibility in trial design to adapt to regulatory changes, potentially moving away from biopsy requirements [25][26] Market Positioning and Competitive Landscape - The recent interest from large pharmaceutical companies in MASH treatments indicates a growing market, with Altimmune positioned to leverage its dual-action therapy [28][30] - The company believes that its single-molecule approach, which combines liver-targeting and metabolic effects, offers a competitive advantage over combination therapies that require multiple drugs [29][34] - Altimmune aims to treat a broad spectrum of patients (F1 to F4) with its drug, addressing both early and late-stage MASH patients [32][33] Financial and Strategic Outlook - Altimmune is focused on improving its balance sheet to fund the Phase 3 trial and is exploring various funding options [39] - The company holds Fast Track status for alcohol use disorder (AUD) and is optimistic about its ongoing trials in this area, with expected readouts in 2026 [36][38] Additional Insights - The company emphasizes the importance of early efficacy in treatment to maintain patient adherence, which is critical given the high discontinuation rates seen with other GLP-1 therapies [16][17] - Altimmune's strategy is to prioritize high-value treatments for complex diseases rather than competing directly in the obesity market, positioning itself as a multifaceted solution provider [38] This summary encapsulates the key insights from the Altimmune conference call, highlighting the company's innovative approach to treating MASH and its strategic positioning in the market.

9月25日，据美国临床试验登记库显示，礼来撤回了ActRIIA/B单抗bimagrumab与司美格鲁肽核心成分tirzepatide联用治疗2型糖尿病患者的IIb期 临床试验，理由是"战略业务原因"。 这项试验原计划为180名既往超重或肥胖并伴有糖尿病的受试者随机给予bimagrumab、tirzepatide或二者联用，监测70周的体重下降及脂肪/肌肉分 布，试验时间自2024年10月21日起、预计2027年1月结束。礼来强调，对所有项目进行例行评估以优化资源，并未透露试验终止的具体原因，外界 普遍解读为公司需要集中资源推进更具前景的肥胖适应症研究。 这一决定并不意味着礼来放弃bimagrumab赛道。公司仍在开展一项针对非糖尿病肥胖成人的II期试验，该试验同样评估bimagrumab与tirzepatide的 联合效果，公司发言人称结果将于2026年读出。 从时间上看，与原计划2027年结束的糖尿病试验相比，肥胖适应症读数提前一年，礼来把精力投向更有望率先获批的肥胖领域。 "高质量减重"依旧重要 bimagrumab由VersanisBio开发，可阻断ActivinⅡ型受体（ActRII），从而抑制肌肉降 ...

Core Insights - The study conducted by Lexaria Bioscience Corp. indicates that the DehydraTECH processing of semaglutide enhances its brain biodistribution compared to conventional formulations, potentially improving safety and efficacy [1][3][6] Study Findings - The primary objective of the study was to assess whether DehydraTECH processing significantly improves the biodistribution of semaglutide [2] - The DehydraTECH-FTS composition showed a higher apparent trend in brain biodistribution across all tested doses, with the 5mg DehydraTECH-FTS achieving greater brain semaglutide fluorescent signal intensity than the 15mg Rybelsus® equivalent [3][5] - Fluorescent imaging revealed that all three DehydraTECH doses tested had higher fluorescence in key brain regions compared to naïve and vehicle groups, while only the highest dosage of Rybelsus® surpassed these groups [5] Mechanism and Implications - The study suggests that enhanced brain biodistribution may be linked to the pharmacodynamic performance of GLP-1 drugs, which are known to interact with brain neurochemistry [6][7] - Semaglutide's ability to regulate body weight through GLP-1 receptor activation in the brain could lead to appetite suppression without common side effects like nausea [6] - Lexaria's findings may support the development of safer and more effective GLP-1 drugs in the future [8] Research Methodology - The preclinical pilot study involved Sprague Dawley rats and utilized non-invasive whole-body imaging and ex vivo organ analysis to evaluate the biodistribution of oral semaglutide [9][12] - A total of 25 male rats were used, with 22 allocated for dosing and 3 as untreated controls, examining both DehydraTECH and Rybelsus® equivalent compositions [12][13] Technology Overview - DehydraTECH is a patented drug delivery platform that enhances the absorption and effectiveness of various drugs, including those that cross the blood-brain barrier [14]

Summary of Novo Nordisk Fireside Chat at EASD Company Overview - **Company**: Novo Nordisk - **Event**: Fireside chat at the 61st edition of EASD in Vienna - **Focus**: Research and Development (R&D) pipeline, particularly in diabetes and obesity Key Points R&D Organization and Strategy - Novo Nordisk has re-merged its research and development organizations to create strategic and scientific synergies, enhancing efficiency and decision-making speed [3][4] - The company remains focused on diabetes and obesity, while also addressing related comorbidities such as cardiovascular and renal diseases [4][5] Pipeline Developments - **Semaglutide**: New data presented at EASD shows a 21% weight loss in obesity treatment, with ongoing regulatory filings in Europe and the U.S. [5][6] - **Oral Semaglutide**: An oral version is under review, with expectations for U.S. regulatory submission in Q4 [6][11] - **CagriSema and Amiglutide**: Upcoming readouts for type 2 diabetes and obesity treatments, with CagriSema expected to show significant results [9][10][13] Clinical Trials and Real-World Evidence - Real-world evidence studies confirm cardiovascular benefits of semaglutide, with a 26% reduction in CV risk in diabetes patients [8][9] - The company emphasizes the importance of flexible titration in clinical trials to reduce dropout rates and improve patient outcomes [42][44] Weight Loss and Patient-Centric Approach - Novo Nordisk recognizes obesity as a complex disease, tailoring treatments to individual patient needs, including options for moderate weight loss with fewer side effects [12][13] - The company aims to maintain muscle strength and functionality during weight loss, with evidence showing that patients do not lose muscle strength with GLP-1 treatments [70][71] Future Directions - The company is exploring the potential of GIP agonists and antagonists in its pipeline, maintaining a curious approach to new biologies [89] - Plans to initiate phase 3 trials for CagriSema and Amiglutide, with a focus on both obesity and diabetes treatment [10][74] Regulatory and Market Considerations - Novo Nordisk is committed to a robust supply chain to ensure full-scale launches of new products, prioritizing patient access [64][65] - The company is aware of the competitive landscape and is focused on differentiating its offerings based on clinical efficacy and safety profiles [56][74] Additional Insights - The company is cautious about the high-risk nature of Alzheimer's trials, acknowledging the challenges in this area [16] - Discussions around the need for active comparator arms in clinical trials highlight the importance of demonstrating superiority or non-inferiority to existing treatments [62] This summary encapsulates the key discussions and insights from the Novo Nordisk Fireside Chat, focusing on their strategic direction, pipeline developments, and commitment to patient-centric care in the diabetes and obesity treatment landscape.

Core Insights - The combination of semaglutide with trevogrumab significantly reduces lean mass loss while enhancing fat loss in patients undergoing weight loss treatment for obesity [1][2][3] - The Phase 2 COURAGE trial results indicate that 33% of weight loss from semaglutide is due to lean mass loss, and trevogrumab can prevent about half of this loss [1][3] Treatment Efficacy - The trial included a weight-loss phase and a weight-maintenance phase, with three primary efficacy endpoints: percent change in lean mass, fat mass, and body weight at week 26 [2] - Detailed results showed that patients receiving semaglutide alone experienced a 6.5% loss in lean mass, while those on trevogrumab combinations had significantly lower losses: 3.3% for lower-dose, 3.8% for higher-dose, and 2.0% for the triplet combination [3] - Fat mass loss was greater in combination groups, with the triplet group achieving a 27.1% reduction compared to 15.7% in the semaglutide monotherapy group [3] Metabolic Improvements - Improvements in metabolic and lipid parameters were observed across all treatment groups, including reductions in waist circumference, blood pressure, cholesterol, triglycerides, and A1C levels [1][5] - The combination therapies demonstrated a favorable profile in preserving muscle mass while promoting fat loss, indicating a meaningful opportunity for obesity treatment [2] Safety and Tolerability - The combination of semaglutide with trevogrumab was generally well-tolerated, with adverse events such as muscle spasms and nausea reported in over 5% of participants [6] - The triplet combination had a higher rate of discontinuations due to tolerability issues, with two deaths reported, although no causal association with treatment was identified [7] Company Overview - Regeneron is focused on developing treatments that improve the quality of weight loss, addressing the issue of muscle loss associated with obesity treatments [9][10] - The company utilizes its proprietary VelocImmune technology to create fully human antibodies, contributing to its innovative pipeline in obesity and related metabolic diseases [11][12]