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Metsera Reports Positive Phase 2b Results for First- and Best-in-Class Ultra-long Acting GLP-1 RA Candidate MET-097i, Enabling Rapid Transition into Phase 3
Globenewswire· 2025-09-29 20:01
Placebo-subtracted mean weight loss up to 14.1% after 28 weeks with no plateau Potential for best-in-class tolerability with minimal diarrhea signal, 13% nausea, and 11% vomiting High study and treatment retention in both VESPER-1 and VESPER-3 trials Data support Phase 3 initiation in late 2025 NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from VESPER-1 and positive data from a planned interim analysis for tolerability of VESPER-3 – two Phas ...
Autonomix Medical, Inc. Initiates Good Laboratory Practice (GLP) Study for Sensing and RF Ablation System
Globenewswire· 2025-09-29 13:15
GLP study marks a key milestone in Autonomix's path to achieve regulatory approvals Company remains on track to submit Investigational Device Exemption (“IDE”), and if approved, commence U.S. clinical trials in 2026 to support a De Novo FDA application THE WOODLANDS, TX, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced that it has commenced a Good Labo ...
Are These GLP-1 Trial Results About to Send Eli Lilly's Stock Soaring?
The Motley Fool· 2025-09-28 14:15
The pharmaceutical company had a clinical setback earlier this year, but that's now in the rearview mirror.Over the past five years, Eli Lilly (LLY 1.43%) has outperformed the broader market, largely thanks to its progress in the GLP-1 arena. Its major breakthroughs in the field are already leading to incredible commercial success.But Lilly isn't done just yet. Recent clinical developments may set the stage for further stock-market gains, and potentially allow the drugmaker to maintain that momentum through ...
Fractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita® Maintained Weight Loss After GLP-1 Discontinuation
Globenewswire· 2025-09-26 11:00
Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients Revita procedure demonstrated excellent safety and tolerability to date, consistent with prior clinical studies Results validate pivotal study design and reinforce Revita’s potential to be the first therapy for post-GLP-1 weight maintenance Company to host investor call and webcast to ...
Eli Lilly's GLP-1 Pill Just Beat Out Novo Nordisk's in a Test. Here's 1 Thing Investors Need to Know.
The Motley Fool· 2025-09-26 08:21
试验结果概述 - 礼来公司发布头对头试验顶线结果 声称其口服GLP-1药物orforglipron在治疗2型糖尿病方面优于诺和诺德口服版Wegovy [2] - 试验主要终点为降低A1C水平(血糖指标) 礼来36mg剂量组A1C降低2.2% 诺和诺德14mg剂量组降低1.4% [3] - 次要终点体重减轻数据显示 礼来36mg剂量组平均减重9.2% 诺和诺德14mg剂量组减重5.3% [4] 数据背景分析 - 诺和诺德正在试验更高剂量25mg口服司美格鲁肽用于肥胖症治疗 远超礼来试验采用的14mg剂量 [4] - 诺和诺德Oasis 4三期试验显示 25mg剂量口服司美格鲁肽实现平均体重减少16.6% [6] - 礼来试验结果不能证明orforglipron在利润更丰厚的肥胖适应症疗效上优于口服司美格鲁肽 [7] 行业竞争态势 - 两种口服药物均未上市销售 试验结果不代表竞争格局已定 [2] - 头对头试验主要针对2型糖尿病治疗 肥胖症适应症存在不同剂量方案 [3][4][7]
Global Partners LP (NYSE:GLP) Shows Confidence in Future Prospects
Financial Modeling Prep· 2025-09-26 02:00
Global Partners LP's recent purchase of 5,000 shares indicates a strong belief in the company's future growth.Zacks Investment Research highlights GLP as potentially undervalued, making it attractive to value investors.With a market capitalization of approximately $1.7 billion, GLP remains a significant player in the Oils-Energy sector.Global Partners LP (NYSE:GLP) is a key player in the Oils-Energy sector, which includes 240 companies and is ranked #14 in the Zacks Sector Rank. The company is involved in t ...
MindWalk Advances AI-Designed GLP-1 Program with First-in-Class Dual-Pathway Regimen for Aging and Longevity
Businesswire· 2025-09-22 11:02
AUSTIN, Texas--(BUSINESS WIRE)---- $HYFT #AI--MindWalk Holdings Corp.â,,¢ ("MindWalk,†"we† or "us† ) (Nasdaq: HYFT), a Bio-Native AI company, today announced "Company,†a major advancement of its AI-designed GLP-1 therapeutics program. New insights from the Company's LensAlâ, g platform reveal a previously unrecognized connection between GLP-1 biology and a second, non- overlapping pathway central to healthy aging and systemic resilience. The findings support a first-in-class dual- pathway regimen in whi ...
Global Partners requests court order to block Applegreen travel plaza deal
Yahoo Finance· 2025-09-22 08:51
This story was originally published on C-Store Dive. To receive daily news and insights, subscribe to our free daily C-Store Dive newsletter. Dive Brief: Global Partners LP has requested a court order to block the Massachusetts Department of Transportation from finalizing its deal with Applegreen to redevelop and operate 18 state highway service plazas, the convenience retailer announced last week. In a lawsuit filed in Suffolk Superior Court, Global Partners said it seeks a temporary restraining order ...
Can Novo Nordisk Hold Its Edge as the GLP-1 Battle With LLY Heats Up?
ZACKS· 2025-09-19 15:55
全球GLP-1市场竞争格局 - 全球GLP-1市场由诺和诺德和礼来主导 诺和诺德推出基于司美格鲁肽的药物Ozempic(用于II型糖尿病)和Wegovy(用于肥胖症) 礼来推出基于替尔泊肽的药物Mounjaro(用于II型糖尿病)和Zepbound(用于肥胖症)[1] - 礼来Mounjaro和Zepbound采用GIP和GLP-1受体激动剂双重作用机制 2025年上半年合计销售额达147亿美元 占礼来总营收52%[6] 头对头临床试验数据对比 - 礼来公布ACHIEVE-3研究数据 其每日一次口服试验药物orforglipron在降低II型糖尿病患者A1C和体重方面优于诺和诺德Rybelsus(口服司美格鲁肽) 但orforglipron因胃肠道副作用导致更高停药率[2] - 诺和诺德公布REACH真实世界头对头研究数据 其Ozempic相比礼来Trulicity(度拉糖肽)降低主要不良心血管事件风险23% 更广泛复合终点风险降低25%[4] - Ozempic是目前唯一获批用于降低II型糖尿病和慢性肾病患者肾病进展及心血管死亡风险的GLP-1受体激动剂[4] 监管批准进展 - 诺和诺德获得欧盟批准在Rybelsus标签中添加心血管获益信息 支持数据显示其降低主要不良心血管事件风险14%[5] - 美国FDA正在审查Rybelsus的类似标签扩展申请 预计今年晚些时候做出决定[5] 新兴竞争者动态 - Viking Therapeutics开发双重GIPR/GLP-1受体激动剂VK2735 包含口服和皮下制剂用于肥胖治疗 口服制剂中期研究结果喜忧参半导致股价大幅下跌 皮下制剂已启动III期肥胖研究[7] 诺和诺德股价与估值表现 - 诺和诺德年初至今股价下跌28.1% 同期行业增长0.5% 表现逊于行业和标普500指数[8] - 公司当前前瞻市盈率为15.43倍 高于行业平均的14.83倍 但远低于其五年均值29.25倍[12] - 过去60天内 2025年每股收益预估从3.98美元下调至3.85美元(下调3.27%) 2026年每股收益预估从4.56美元下调至4.07美元(下调10.75%)[15][17] - 诺和诺德目前获Zacks排名第5(强烈卖出)[17]
Eli Lilly's Oral GLP-1 Breakthrough Could Change Everything
MarketBeat· 2025-09-18 19:25
公司股价表现 - 过去12个月公司股票表现优异 是AI增强的"瑰丽7股"之外表现最佳的股票之一 [1] - 过去一个月股价上涨10% 主要受FDA可能加速审批口服GLP-1候选药物的消息推动 [2] - 过去五年股价上涨近400% 尽管最近一年半被部分交易员称为"僵尸股" [8] - 当前股价761.52美元 52周区间为623.78-939.86美元 [1] - 分析师给出的12个月目标价平均为939.61美元 较当前价格有23.73%上行空间 [3] GLP-1市场地位 - 公司是GLP-1市场领导者 该市场正在改变2型糖尿病和肥胖症的治疗方式 [1] - 口服GLP-1解决方案可能重新定义该领域的可及性和成本动态 显著扩大GLP-1市场规模 [2] - 虽然多家公司都在测试口服GLP-1解决方案 但公司进展最为领先 [4] - 诺和诺德是主要竞争对手 但公司在药物开发速度和制造规模方面仍保持优势 [8] 口服GLP-1药物进展 - FDA可能通过新推出的1-2个月快速审查流程加速审批该药物 [4] - 口服给药方式若能降低成本 可能提高保险覆盖意愿 目前用于减肥的GLP-1药物很少被保险覆盖 [5] - 口服解决方案解决了用户不喜欢或不愿处理持续针头注射的问题 [2] 制造战略与投资 - 公司战略投资270亿美元用于美国制造业 [6] - 承诺50亿美元在弗吉尼亚州建设制造工厂 提高国内口服GLP-1候选药物和肿瘤药物的生产能力 [6] - 这是公司计划在美国建设的四个新设施中的第一个 [6] - 此举解决了两党对制药供应链脆弱性的担忧 减少关税风险 并可能获得监管机构的认可 [7] 财务指标与估值 - 市盈率为49.79倍 [1] - 远期市盈率为32倍 虽然高于其他大型制药公司 但相对于历史平均水平和GLP-1药物主导地位具有良好价值 [12][13] - 股息收益率为0.79% 年度股息为6美元/股 [10][13] - 股息已连续11年增长 派息比率约为39% 具有可持续性 [10][13] 产品管线与增长动力 - 除了GLP-1药物外 公司的肿瘤学和抗体药物偶联物管线提供进一步增长机会 [11] - 美国制造重点是一个战略护城河 可多元化收入基础并降低政治和物流风险 [11] - 肥胖治疗保险覆盖的不确定性可能影响短期盈利 但长期前景保持完整 [9]