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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 ...
礼来叫停bima糖尿病联用试验,来凯“被点名”股价大涨
华尔街见闻· 2025-09-26 08:04
礼来临床试验调整 - 礼来因战略业务原因撤回bimagrumab与tirzepatide联用治疗2型糖尿病患者的IIb期临床试验 原计划入组180名受试者 试验时间从2024年10月21日至2027年1月 公司称此为资源优化举措 [1] - 公司仍继续推进非糖尿病肥胖成人的II期试验 该试验评估相同联合疗法 预计入组240名受试者 结果将于2026年读出 比原糖尿病试验提前一年 [1][3] - 终止糖尿病试验的原因包括该适应症审批路径更复杂 且在GLP-1疗法已成熟背景下叠加抗体药物的优势不确定 [3] bimagrumab作用机制与数据 - bimagrumab通过阻断ActivinⅡ型受体抑制肌肉降解并促进肌肉生长 在BELIEVE 2b期试验中与semaglutide联用72周平均体重下降22.1% 其中92.8%体重下降来自脂肪 瘦体重几乎保持不变 [2] - semaglutide单药治疗体重下降15.7% 仅71.8%来自脂肪 而bimagrumab单药体重下降10.8% 全部来自脂肪且瘦体重增加2.5% [2] - 该药物旨在解决GLP-1药物导致的肌肉流失问题 实现减脂不减肌 但联合疗法仍需证明在肌肉功能改善或代谢指标优化方面的综合获益 [2] 来凯医药合作与市场反应 - 礼来终止试验后 来凯医药股价一度上涨超过15% 因bimagrumab退出糖尿病试验削弱潜在竞争 同时凸显来凯与礼来合作的LAE102管线价值 [4] - LAE102为来凯自主研发的ActRIIA单克隆抗体 2024年11月与礼来达成全球合作 礼来负责美国市场临床开发和商业化 来凯保留全球权益 预计2025年下半年公布多剂量递增研究初步结果 [5] - 来凯在2025年6月美国糖尿病协会学术会上公布首个人体研究数据 显示LAE102在保持瘦体重同时减少脂肪 公司计划与礼来推进联合疗法打造下一代高质量减重药物 [6] 临床试验设计与安全性 - LAE102首个人体研究设计包括健康受试者单次静脉或皮下注射 设4个剂量水平 并招募超重与肥胖人群进行探索 [8] - 单次给药后无严重不良事件 多数为1级注射部位反应 无实验室异常 药代动力学显示高剂量组ActivinA升高持续约28天 表明长半衰期和持续靶点抑制能力 [8] - 数据支持在超重与肥胖人群中的潜在疗效 为后续临床推进提供依据 [8] 市场竞争与行业格局 - 多家公司瞄准减脂不减肌赛道 包括Regeneron/ScholarRock双抗组合 Veru的口服enobosarm以及Biohaven的myostatin抑制剂 均公布早期肌肉保护数据 [9] - 肌肉保护型减肥药市场规模到2035年有望达数百亿美元 各公司计划在GLP-1药物基础上叠加肌肉调节因子以证明额外临床获益 [9] - 礼来肥胖管线包括已获批减肥适应症的tirzepatide 三期中的retatrutide 口服orforglipron 以及与Camurus和JuvenaTherapeutics的合作项目 [11] 战略重心与未来展望 - 礼来将资源集中于更具前景的肥胖适应症 肥胖试验数据读出时间提前至2026年 最快2027年前后申报联合疗法肥胖适应症 [3][9] - bimagrumab肥胖试验与LAE102多剂量试验将于未来一年内公布结果 决定减脂不减肌赛道是否具备长期潜力 [9]
Here’s What Dragged Eli Lilly and Company (LLY) Down in Q2
Yahoo Finance· 2025-09-25 14:02
PGIM, an investment management company, released its “PGIM Jennison Health Sciences Fund” second-quarter 2025 investor letter. A copy of the letter can be downloaded here. Equities in the second quarter of 2025 experienced significant volatility, as the steep sell-off that initiated at the beginning of the quarter ultimately led to a strong recovery. The S&P 1500 Health Care Index declined 6.9% in the second quarter, underperforming the S&P 500’s 10.9% return. Health care providers & services, life science ...
Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA for Greater Weight Loss in the Treatment of Obesity
Globenewswire· 2025-09-23 12:30
MIAMI, FL, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced a successful meeting with FDA providing regulatory clarity for enobosarm, a selective androgen receptor modulator, as a muscle preservation drug product candidate in combination with GLP-1 RA for greater weight loss for the treatment of obesity. Highlights from FDA mee ...
eCIO Initiates Stake in Eli Lilly and Company (LLY) with 886 Shares
Yahoo Finance· 2025-09-18 14:57
Eli Lilly and Company (NYSE:LLY) is among the high growth mega cap stocks you can buy and hold for the next 3 years. During the first quarter, eCIO Inc. acquired a new position in Eli Lilly and Company (NYSE:LLY) through the purchase of 886 shares. According to the latest disclosure with the SEC, the firm’s investment in the company is valued at approximately $732,000. At a time when being lean is the new luxury, Eli Lilly and Company (NYSE:LLY) is doing what it does best. The company is focusing on obesi ...
Novo Nordisk's Wegovy Outperforms Eli Lilly's Tirzepatide In Reducing Risk Of Heart Attack, Stroke, And Death: Study
Benzinga· 2025-09-18 12:57
Novo Nordisk A/S NVO presented data from the STEER real-world study of evidence gathered from actual patient experiences at the European Society of Cardiology (ESC) Congress 2025.The STEER study investigated the risk of major adverse cardiovascular events (MACE) with Wegovy (semaglutide) 2.4 mg compared with Eli Lilly and Co.’s LLY tirzepatide treatment in people with overweight or obesity and established CVD without diabetes.DataCompared with tirzepatide, Wegovy showed a significant 57% greater risk reduct ...
Citi Maintains a Buy Rating on Eli Lilly and Company (LLY), Retains the $1,190 PT
Yahoo Finance· 2025-09-16 18:58
Eli Lilly and Company (NYSE:LLY) is one of the best drug stocks to buy right now. Citi analyst Geoff Meacham maintained a Buy rating on Eli Lilly and Company (NYSE:LLY) on September 10, retaining the price target of $1,190.00. Was Jim Cramer Right About Eli Lilly and Company (LLY)? The analyst supported the optimistic outlook with the promising outlook for the company’s obesity treatment, tirzepatide, stating that the treatment attained the highest cost-effectiveness rating in the recent draft report by ...
Here Is My Top Stock Pick Among the Weight Loss Industry Leaders
The Motley Fool· 2025-09-16 07:15
市场规模与增长 - 减肥药市场预计在五年内达到950亿美元 从今年的280亿美元增长至十年末的950亿美元 [1][2] - 新一代高效减肥药为行业领导者礼来和诺和诺德创造了数十亿美元收入 并吸引了Viking Therapeutics和安进等公司开发竞争性候选药物 [1] 行业驱动因素 - 减肥药需求持续高涨 礼来和诺和诺德的产品去年大部分时间被列入FDA短缺清单 [4] - 公众人物(如网球冠军塞雷娜·威廉姆斯)和普通用户的有效性证言维持了市场高度关注 [5] - GLP-1受体激动剂药物适应症扩大(如肥胖症和睡眠呼吸暂停)拓展了目标患者群体 [5] - 健康意识提升促使更多人选择GLP-1药物以预防体重相关健康问题 [5] 礼来公司核心优势 - 替尔泊肽(商品名Mounjaro和Zepbound)第二季度推动公司收入增长38% [6][8] - 口服减肥候选药物orforglipron在3期临床试验中实现平均减重超12%(72周) 预计年底提交监管审批 [8][9] - 另一候选药物retatrutide(3期研究中)可能比Zepbound具有更高疗效 [11] - 口服制剂orforglipron相比诺和诺德口服版Wegovy无需饮食限制 且生产成本更低 [12][13] 竞争格局 - 口服orforglipron在制造便利性和用药体验上优于肽类口服药物(如Wegovy) [12][13] - 礼来股票以33倍前瞻市盈率交易 低于去年的60倍比率 [14]
2 S&P 500 Dividend Stocks That Could Climb More Than 20% According to Wall Street Analysts
The Motley Fool· 2025-09-05 08:29
华尔街分析师看涨股息股票 - 华尔街分析师对礼来和康菲石油两只派息股票持看涨观点 预期未来12个月回报率超过20% [1][2] - 礼来共识目标价950.17美元 较近期股价735美元存在29%上涨空间 [4] - 康菲石油共识目标价120.95美元 较近期股价95美元存在28%上涨空间 [10] 礼来公司(LLY)投资亮点 - 股价从前期高点下跌超50% 主要因口服减肥药orforglipron临床试验结果不及预期 [4][5] - 最高剂量orforglipron治疗72周后平均体重减轻12.4% 而注射药物Zepbound同期减重效果达20.9% [5] - 替尔泊肽(tirzepatide)作为Zepbound(减肥适应症)和Mounjaro(糖尿病适应症)活性成分 2025年上半年销售额同比增长121%至147亿美元 [6] - 乳腺癌药物Verzenio 2025年上半年销售额同比增长11%至27亿美元 [8] - 过去五年股息支付额增长超一倍 当前股息收益率0.8% [9] 康菲石油(COP)投资亮点 - 股价较历史高点下跌约30% 但季度股息每股0.78美元较2023年大幅提升并保持稳定 当前股息收益率3.3% [10] - 第二季度斥资12亿美元进行股票回购 较股息支出多2亿美元 自去年11月收购Marathon Oil以来流通股减少3.5% [11] - 尽管油价持续低于80美元/桶 公司仍通过Marathon Oil整合、资产出售和税收优惠持续回馈股东 [12] - 管理层预计未来四年年自由现金流将增加超70亿美元 [12]
Zealand Pharma (ZLDP.Y) 2025 Conference Transcript
2025-09-04 13:02
[角色] 你是一名拥有10年投资银行从业经验的资深研究分析师,专门负责上市公司、行业研究。你擅长解读公司财报、行业动态、宏观市场,发现潜在的投资机会和风险。 [任务] 你需要仔细研读一份上市公司或者行业研究的电话会议记录,请阅读全文,一步一步思考,总结全文列出关键要点,不要错过任何信息,包括: * 纪要涉及的行业或者公司 * 纪要提到的核心观点和论据 * 其他重要但是可能被忽略的内容 如果没有相关内容,请跳过这一部分,进行其他的部分。 总结时要全面、详细、尽可能覆盖全部的内容、不遗漏重点,并根据上述方面对内容进行分组。 要引用原文数字数据和百分比变化,注意单位换算(billion=十亿,million=百万,thousand=千)。 [注意事项] 1) 使用中文,不要出现句号 2) 采用markdown格式 3) 不使用第一人称,以"公司"、"行业"代替 4) 只输出关于公司和行业的内容 5) 在每一个关键点后用[序号]形式引用原文档id 6) 一个[序号]只应该包含一个数字,不能包含多个,如果多个就用[序号][序号]分开写,不要写成 [序号-序号] 7) 每个关键要点后边的 [序号] 不要超过 3 个 Content: --------- <doc id='1'>Company Participants Adam Steensberg - President & CEO Prakhar Agrawal - Managing Director Adam Steensberg People dropping off the GLP-1s. And we think we have with PetriniType an alternative product that can give patients the weight loss they're looking for, but in a more pleasant weight loss experience. And we really think that, you know, the dynamics we're looking at today will only be exaggerated further as we see alternatives coming out because then the conversations will change from can you tolerate a therapy to will you accept it? If there is an alternative, what will patients accept? And we at least speculate that even more patients will not accept being on a GLP-one with all the side effects you often see with these molecules.</doc> <doc id='2'>Prakhar Agrawal Got it, and obviously we've seen a lot of activity in the amylin space recently, so there was cabrizema data at ADA, Lilly presented some data for their amylin drug which is with a cabrizema, it's a little bit early stage, Metsarah has an Amylin. So with all those competition coming in, which everyone probably predicted would happen, how do you sort of highlight some of petrolinitis differentiation in this increasing incompetent space? Space?</doc> <doc id='3'>Adam Steensberg Yeah. It is really good to start to see more clinical data readouts in this space of the amylin. And I would say with all the data that we have seen coming out this year, that confirms to us that we have what still looks to be the best in class opportunity. When you look at the totality of data, it is still important when you look at these molecules that you do not only focus on, let's say, efficacy and then disregard safety at the same. So you need to balance always what is what is the efficacy you're looking for and what is the safety profile that is our tolerability profile that comes along that efficacy.</doc> <doc id='4'>And when we look at the totality of of that experience, we still think that the Treinside by far looks to have the strongest profile among these clinical assets. If you take the quinolantide, which is of course the one that is furthest developed, where Novo's main focus so far has been Carcurisema, that's a combination product. That's not an alternative. And then but what we were excited about, considering that data set from their phase three program was actually the arm where they also tested monotherapy of cadrelioside, where they actually showed 12% weight loss with almost placebo like side effects. And we think we have a product that will give more weight loss due to the specific features of our molecules that really reconfirm our belief that Petrides has the potential to really lead in this new category and also that the category can actually become the largest category</doc> <doc id='5'>Prakhar Agrawal Okay. And maybe can you help us understand the specific differentiation versus gagrelentide? Is it the half life, potency or something else that you can do with petrolentide? Adam Steensberg Yeah. So a lot of these there's of course a lot lot of, you can say, scientific rigor behind choosing these molecules. And if you think about coagrelin type by Novo Nordisk and then petraintide by us, the way it interacts with the amylin receptors and the calitronin receptors, we believe are quite similar. And that's why it's really reassuring not only the efficacy signal from cadherin type, but also the safety signal from cadherin type. So we have a very balanced approach and we use also human amylin as the backbone.</doc> <doc id='6'>Other companies have chosen different paths and I think we are starting to see now that maybe some of those decisions will then carry out carry some side effects and maybe even some quite significant safety signals, which so far it looks like we have avoided with the decisions we have made. Compared to caquilinide, we have a significant upside in the fact that we our molecule is stable and neutral pH, and what we believe that translate into is that we don't see the same degree of injection site reactions as has seen with ekaglutide, we have not seen</doc> <doc id='7'>the same degree of immunogenicity. And then we have a much higher bioavailability, so we get more drug to the receptor when we inject.</doc> <doc id='8'>Prakhar Agrawal Okay, got it. And you announced a deal with Roche earlier in the year. I thought it was great economics. But maybe strategically, why did you feel Roche was the right partner to maximize the value of Betterment Day? Adam Steensberg Yes.</doc> <doc id='9'>So we after we got our Phase 1b data last summer last year, we started a very kind of structured process to identify the right pharma partner for us to realize our vision of becoming a key player in obesity, which was extremely important for us, this was a very competitive process. I had been on quite a few last cap CEOs to ultimately choose us. What was extremely important for us was the strong commitment they have made to actually become a leader in this space. We didn't just wanna team up with somebody who just thought it would be hard to have an obesity asset. We actually, it's a big effort to go in and lead in this space and that was with with us.</doc> <doc id='10'>We found a company who convinced us that they wanna lead in this. We were impressed with how they presented their manufacturing plans because ultimately, you cannot just tap into existing manufacturing capacity. Yes, you can do that, but then you will not get the most efficient. And they convinced us that the plans they have by building new fit for purpose manufacturing capacity would be a huge edge for us as we launch these molecules together. And then of course, lastly, we actually managed to get 50% shared economics on also the combination products with their c c d three eighty eight, which is a GLP one GLP molecule.</doc> <doc id='11'>So of course, that added to the value opportunity. So so, yes, we are now sharing the the profit fifty fifty with us, but we actually also got a new value opportunity in, and at the same time, a lot of good economics. So those were probably the three main reasons.</doc> <doc id='12'>Prakhar Agrawal Yes. And on the manufacturing investments, we saw some announcements from Roche as well. I think 700,000,000 investment in the North Carolina plant. Like how much of that capacity is going to be focused on petrolinta, if you can speak about that? Adam Steensberg Yes, I cannot share the specifics, but just I can share that we feel very confident that HUS is making the right investments in this investments needed to support the launch without any, you can say, shortage. And it's perhaps also an aspect of this agreement which has been overlooked a little bit that while we will share all development cost and also the future profit, we, Zealand, do not have to finance any manufacturing investments. That would be us that is responsible for financing all these investments, which is of course also a lot of dollars short term at least for us that we save.</doc> <doc id='13'>Prakhar Agrawal Got it. And when you were running the process and like what was attractive, what better than tied to Roche, what were the some of the two or three attributes that was really interesting? Was it a differentiated mechanism? Was it on the safety tolerability side? If you can just lay out the reasons that Roche will tolerate, we have to be involved in the ambulance space.</doc> <doc id='14'>Adam Steensberg Yes. I think they will, of course, have to speak for themselves either ultimately were so excited as I would say most of their peers in the industry was as well. So but I would but for me, it's a logical consequence of looking at the current market dynamics. With the GLP-1s, where we have two established brands, of course, it's going to be hugely difficult to come in with another GLP-one and start to lead if you already have very established brands. You're You're going to have high rebate walls, you're going to have a lot of prescribing experience with</doc> <doc id='15'>existing molecules, and you're also going to fight against ten, twenty years of data. So but coming in with a new modality, coming in with an alternative, then suddenly you have an opportunity to lead in a new category instead of trying to eat your way into something that is very established.</doc> <doc id='16'>That is a much more attractive value proposition. Also, you think about the launch years, it's it's a much more compelling opportunity to launch with a new category because you will be you can say the first alternative for people who do not know where else to go, if you launch and with a similar mode of action, then you will have to convince somebody why you should take that molecule rather than a new in a in a very existing and well known molecular entity. So this opportunity to lead in a new category, I think, is what was appealing to many of the companies we spoke to.</doc> <doc id='17'>Prakhar Agrawal Got it. Makes sense. Maybe onto the some of the clinical data, you have the ongoing Phase 2b that will read out the forty two weeks will read out next year. Just clear on what are you hoping to see maybe starting with efficacy? Adam Steensberg Yes. So what we hope to see is a molecule that can provide patients with a GLP-one like weight loss, and that is in the mid teens, so fifteen percent to twenty percent what we have seen. And then with a much more benign tolerability profile, we are already very confident in the tolerability profile because we have sixteen week data. We have also data from Novo Nordisk, which shows that it's almost placebo like experience that you have when you get a patrinetide as compared to when you get the GLP-1s. So and on the efficacy side, we achieved 8.6% weight loss over sixteen weeks.</doc> <doc id='18'>And those models would suggest that we can easily achieve the weight loss we're looking for. What I think is super important as we continue to mature our view on the future BT market is to maybe that go a little bit of that, what is the number? This is about a profile of a drug. Most patients, if you ask them, are looking for a 10% to 20% weight loss. And we and and thus, we we have to get away from this weight loss Olympics.</doc> <doc id='19'>We need to get into talking about what is the profile of the drug, which drugs can give patients that weight loss they're looking for, but in a more pleasant experience. And then importantly, which is the big big big miss of the current therapies is how do we manage to get patients to stay in therapy. The reason that we have so low volumes of patients on treatment is because they stopped taking the GLP-1s far, far too early today. And we think we can change that with enamelin.</doc> <doc id='20'>Prakhar Agrawal Yes. And I think that's an important point because I think people under appreciate the duration of therapy for Alnylam drug. So like what are you based on your research, what's the sort of the state time for GLP-1s and how much further can you improve with an amylin therapy even as monotherapy option? Adam Steensberg Yes, but I think it has actually not changed a lot this daytime on a GLP-1s. And we know, I mean, from the launch years, I mean that within the one already in one once we have thirty percent who drops off and probably within a year is less than than fifty percent who are still on on therapy. By those who leaves, the majority are actually people who say it's because I cannot tolerate the drug. Of course, there are other reasons as well, but the major极是 because they cannot tolerate it. And there's actually a big dilemma here because if you only achieve a weight loss and you don't manage to maintain it, we actually you could actually be worse off.</doc> <doc id='21'>So it is so important we start to think about how do we get people to stay on therapy. And we all know that an obese person is very motivated to lose weight. Once you have achieved the weight loss, you become less motivated, and that also means that you will accept less side effects. And that's where we think amylin will come in and be something you can actually have that you can also enjoy being on when you have achieved your 极是 loss because it has this feature of making people feel full faster rather than losing their appetite. So it's actually also beyond the classical tolerability issues</doc> <doc id='22'>Prakhar Agrawal</doc> <极是 id='23'>And on the safety tolerability side, obviously, we have been comparing it with semaglutide, but don't you think the market is moving now more closer to tirzepatide, which has really good safety tolerability as well, so how would you compare ambulance versus let's say dual agonist, like Adam Steensberg a GLP, GLP agonist which has good safety? Yeah, but I politely probably have to disagree with your statement there. In my book, think the safety and tolerability profiles between Vigovi and and and Zepbound are quite similar. You may data at least suggest that you could get a higher weight loss on on Zepbound, but again, as we discussed before, if you balance things net net, you still have all the side effects with the GLP one TIP class that we have also seen with the GLP one class. I think another kind of fact underscoring this is that while the clinical data we always discuss for these molecules are data generated with the highest doses,极是 what was the weight loss you achieved with, let's say, fifteen milligrams of of of of Z bound, then the real world evidence suggests that very, few patients ever get to these doses.</doc> <doc id='24'>They end at much lower doses. I actually believe that the average dose being used real world for Zepbound is around seven and a half milligram, which is a very low dose. So they don't actually experience the weight loss that the clinical data suggest they can do. And then you might ask yourself, why is that? Why do they not get to those numbers? And we think a lot of that has to do with the tolerability profile. We used to talk a lot about just vomiting and nausea, but I think we need to discuss diarrhea in particular because these are side effects that tend to stick and not be able to titrate yourself out, especially when we start to think about the new classes of all GLP-1极是 where in my book, at least looks to be even worse.</doc> <doc id='25'>Prakhar Agrawal Got it. And you disclosed some pooled baselines during the last earnings call. But maybe just a broader question on obesity trials. We are seeing a lot of discontinuations in the obesity trials, especially in the placebo arm as well. We saw this with Lilly's orfagriplone data. Viking had a little readout that had极是 lot of disc conditions as well. What are you doing to mitigate this risk? Because this is a forty two week trial as well.</doc> <doc id='26'>Adam Steensberg Yes. But I mean, we, of course, don't have the data yet, but but I also hear other companies who have not seen the same issue. So I I don't know. Before we see the actual data, it's it's actually difficult to say what the real reasons are behind those discontinuations. Of course, there is this observation that if people don't achieve a weight loss in a placebo group, they could be less motivated to stay in the study.</极是> <doc id='27'>That could also, again, coming back to ofroglipin, why you had more discontinuations than average on on even on active drug because people did not achieve the weight loss they were looking for. So I think we need to see the individual data before we can start to draw conclusions.</doc> <doc id='28'>Prakhar Agrawal Anything you can comment on the pool discrimination rates in the ongoing trial? Adam Steensberg No. I mean, again, we try to keep a high level of data integrity on our clinical studies and not be too, you can say, to introduce any risks. So we like to keep things blinded until we have the data.</doc> <doc id='29'>Prakhar Agrawal Okay. And once you have the forty two weeks, I know there will be an interim readout this year to progress for to start the regulatory discussions around the Phase III plan. But what could a Phase III development plan look like? And a follow-up to that, like does Roche plan to run a CV outcomes trial for Amlens? Adam Steens