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.

In this articlePFEMTSRThomas Fuller | SOPA Images | Lightrocket | Getty ImagesA version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.Pfizer's newest bet on obesity is already showing promise. The company last week said it would buy weight loss drugmaker Metsera in an up to $7.3 billion deal, including future payments, that is expected to close at the end of the year. Just a week ...

Core Insights - Novo Nordisk has experienced significant commercial success with its semaglutide products, Wegovy and Ozempic, but its growth has recently slowed due to increased competition [1] - The company revised its sales and profit outlook for 2025, citing slower uptake of Wegovy and Ozempic amid competition from Eli Lilly's tirzepatide-based drugs [2] - Novo Nordisk is developing next-generation obesity candidates to maintain its leadership position in the U.S. market [3] Product Development - The most advanced candidate in Novo Nordisk's pipeline is CagriSema, which combines cagrilintide and Wegovy, having met primary endpoints in late-stage studies but showing lower-than-expected weight loss [4] - Novo Nordisk reported superior weight loss results from a sub-analysis of its phase III study on cagrilintide, supporting its obesity pipeline expansion strategy [5] - The company is also developing oral and subcutaneous formulations of amycretin, which outperformed Wegovy in early-stage studies [5] Strategic Moves - Novo Nordisk is pursuing licensing deals and acquisitions to enhance its obesity pipeline, including the acquisition of Inversago Pharmaceuticals and a $2.2 billion deal with Septerna [6] - The strategic focus on next-generation obesity candidates and targeted acquisitions reflects a calculated approach to sustain market leadership [7] Competitive Landscape - Eli Lilly is a major competitor, marketing its tirzepatide medicines and investing in new obesity treatments, including late-stage candidates [8] - Other companies, such as Viking Therapeutics, are also advancing GLP-1-based candidates, indicating a competitive environment in the obesity treatment space [9]

Revita Program - The durable weight maintenance market represents an untapped opportunity of approximately $175 billion[7] - 85% of patients regain weight after stopping GLP-1 drugs, highlighting a significant unmet clinical and economic need[10] - The REMAIN-1 Pivotal Cohort is on track to complete randomization in early 2026, with potential PMA filing in H2 2026[10] - In the REMAIN-1 Midpoint Cohort study, Revita patients experienced a further 2.5% weight loss after stopping GLP-1s, compared to a 10% weight regain in sham-treated patients (p=0.014) at 3 months[54] Rejuva Program - The company submitted the first CTA module in the EU for RJVA-001, with anticipated preliminary data in 2026[10] - Rejuva aims for a cost of goods (COGs) of less than $10,000 per patient, targeting a price benchmark of approximately $10,000 per year based on ICER pricing[92] - Preclinical data showed that Rejuva's RJVA-001 demonstrated glucose-lowering activity and improved weight compared to daily semaglutide in a db/db murine model[101] - In a DIO mouse model, RJVA-001 prototype showed sustained weight loss while preserving lean mass, outperforming semaglutide[104] Intellectual Property - The company has a robust intellectual property estate with 100+ patents issued globally, including 33 U S patents, and 70+ pending patent applications as of June 2025[135]

Lilly halts a study of an experimental drug designed to prevent obesity patients from losing too much muscle, citing strategic business reasons https://t.co/isjH65RANR ...

Group 1 - Roche aims to become a top three player in the global obesity market, competing with Novo Nordisk and Eli Lilly as it advances its experimental weight-loss drug to late-stage trials [1][2] - The company announced that its CT-388 weight loss injection is entering phase III trials, which is the final stage before seeking regulatory approval, indicating progress in Roche's obesity treatment pipeline [2] - Roche plans to launch its suite of obesity treatments by 2030, despite currently having no approved obesity drugs on the market [2] Group 2 - Roche is co-developing the Petrelintide drug candidate in a $5.3 billion partnership with Zealand Pharma, which is a significant step in its obesity treatment strategy [3] - Petrelintide is an amylin analog that complements Roche's existing GLP-1 offerings, including CT-388 and CT-996, acquired through the purchase of Carmot Therapeutics in late 2023 [4] - The company is committed to accelerating the timeline for Petrelintide's development [3]

以下文章来源于肥胖世界ObesityWorld ，作者肥胖世界 肥胖世界ObesityWorld . 《肥胖世界》Obesity World - 同步传真肥胖及代谢国际新学术进展，为医学减重临床、教研人员搭建一座与国际接轨的桥梁，「每医健」旗下内容平台。 实际上，GLP-1受体激动剂最初获批用于治疗2型糖尿病。从机理上看，肠道产生的GLP-1激素能刺激胰岛素分泌，有效降低并稳定血糖水 平。正是早期临床试验中意外发现的体重减轻效果，催生了这一减肥"神药"的后续爆红。 动物实验发现，NMDA受体拮抗剂(MK-801)可诱导小鼠产生厌食反应并减轻体重，这一发现与GLP-1效应极为相似。然而，研究者在直接使 用MK-801非选择性阻断NMDA受体时，小鼠出现高热、兴奋性运动等严重不良反应，迫使团队放弃单独使用该药物。 2021年，FDA批准了名为司美格鲁肽的胰高血糖素样肽-1(GLP-1)受体激动剂用于长期控制肥胖和超重成人患者体重。临床试验显示，每周一 次的司美格鲁肽注射能使肥胖患者体重平均减少15%。凭借其在肥胖治疗领域的革命性影响，GLP-1激动剂荣获《科学》杂志2023年度科学突 破称号。 然而，单一GLP- ...

Core Insights - Novo Nordisk and Eli Lilly are leading the diabetes and obesity market with their GLP-1 products, including Lilly's Mounjaro and Zepbound, and Novo Nordisk's Ozempic, Rybelsus, and Wegovy [1][2] Company Performance - Lilly's Cardiometabolic Health segment generated nearly $15 billion in sales in the first half of 2025, while Novo Nordisk's Diabetes and Obesity care segment generated $21.1 billion (DKK 145.4 billion) [2] - Lilly's Mounjaro and Zepbound account for approximately 50% of its total revenues, while Novo Nordisk's GLP-1 sales in diabetes increased by 10% in the first half of 2025, capturing a 51.9% market share [4][11] Growth Prospects - Lilly expects revenues between $60.0 billion to $62.0 billion in 2025, indicating over 30% year-over-year growth, driven by new drug approvals and market expansion [7][10] - Novo Nordisk is investing heavily in expanding manufacturing capacity and has received recent approvals for its semaglutide medicines, which are expected to boost sales [12][11] Competitive Landscape - The obesity market is projected to grow to $100 billion by 2030, with both companies developing next-generation obesity drugs to maintain market dominance [15] - Rising competition from other companies, such as Amgen and Viking Therapeutics, is intensifying in the GLP-1 diabetes and obesity market [16] Financial Estimates - The Zacks Consensus Estimate for Lilly's 2025 sales and EPS implies a year-over-year increase of 37.2% and 77.3%, respectively, while Novo Nordisk's estimates indicate a 15.3% sales increase and 17.4% EPS increase [20][22] Valuation Metrics - Lilly's stock trades at a forward P/E ratio of 25.92, higher than Novo Nordisk's 14.84, indicating a more expensive valuation for Lilly [24] - Lilly's dividend yield is 0.8%, while Novo Nordisk's is around 2.4% [25] Market Position - Lilly has a market cap exceeding $700 billion, significantly larger than Novo Nordisk's market cap of around $270 billion, reflecting its diversified product portfolio and growth prospects [30]

Amid the ongoing United States stock market rally, several equities have experienced increased buying pressure, pushing their valuations closer to the coveted $1 trillion market capitalization mark.With the new year on the horizon, the following two U.S. companies are increasingly showing the potential to break into the trillion-dollar club, driven by ambitious fundamentals.Oracle (NASDAQ: ORCL)At roughly $867 billion in market value, Oracle (NASDAQ: ORCL) is only 15% away from the trillion-dollar threshold ...

Pfizer's latest deal could make it the budget entry point to the weight-loss bonanza. ...