GGGgGg-To The Moon - Tiger Brokers Online Investing Community - To The Moon

1
Comment
Favorite

梓笋
2021-06-08

GGGgGg

Biogen's Alzheimer's disease drug was approved by FDA, and its stock soared 64%

百健公司有争议的阿尔茨海默病疗法获得美国监管机构的批准，这项具有里程碑意义的决定将极大改变脑功能退化问题的治疗方法。FDA周一发布公告称，允许该药物上市，因为它减少了类淀粉蛋白的水平——这是一种堵塞阿尔茨海默病患者大脑的粘性有害蛋白质。百健公司计划以Aduhelm的品牌名称销售该药物。此次批准是近年来FDA最重要的决定之一，对数百万阿尔茨海默病患者及其家人来说是个福音。其他从事阿尔茨海默病疗法研究的公司也上涨。

Biogen's Alzheimer's disease drug was approved by FDA, and its stock soared 64%

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

1

Report

Comment

Top
Latest

empty

No comments yet

Most Discussed

{"i18n":{"language":"en_US"},"data":{"magic":2,"id":117981854,"tweetId":"117981854","gmtCreate":1623113524978,"gmtModify":1704196267712,"author":{"id":3573083490665949,"idStr":"3573083490665949","authorId":3573083490665949,"authorIdStr":"3573083490665949","name":"梓笋","avatar":"https://static.tigerbbs.com/8a294795cbcf0a404e687023dcd20aeb","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":0,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"extraTitle":"","html":"<html><head></head><body><p>GGGgGg</p></body></html>","htmlText":"<html><head></head><body><p>GGGgGg</p></body></html>","text":"GGGgGg","highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://ttm.financial/post/117981854","repostId":2141258798,"repostType":4,"repost":{"id":"2141258798","kind":"news","weMediaInfo":{"introduction":"为用户提供金融资讯、行情、数据，旨在帮助投资者理解世界，做投资决策。","home_visible":1,"media_name":"老虎资讯综合","id":"102","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1623112269,"share":"https://ttm.financial/m/news/2141258798?lang=en_US&edition=fundamental","pubTime":"2021-06-08 08:31","market":"us","language":"zh","title":"Biogen's Alzheimer's disease drug was approved by FDA, and its stock soared 64%","url":"https://stock-news.laohu8.com/highlight/detail?id=2141258798","media":"老虎资讯综合","summary":"百健公司有争议的阿尔茨海默病疗法获得美国监管机构的批准，这项具有里程碑意义的决定将极大改变脑功能退化问题的治疗方法。FDA周一发布公告称，允许该药物上市，因为它减少了类淀粉蛋白的水平——这是一种堵塞阿尔茨海默病患者大脑的粘性有害蛋白质。百健公司计划以Aduhelm的品牌名称销售该药物。此次批准是近年来FDA最重要的决定之一，对数百万阿尔茨海默病患者及其家人来说是个福音。其他从事阿尔茨海默病疗法研究的公司也上涨。","content":"<p>The U.S. Food and Drug Administration (FDA) approved Biogen's experimental drug aducanumab (trade name: Aduhelm) for the treatment of Alzheimer's disease on Monday, Eastern Time. This is the first time in nearly 20 years that the FDA has approved the treatment of the disease. New drugs. Reuters pointed out in the report that Aduhelm can slow down the course of the patient's disease by removing the sticky deposits in the patient's brain, thereby slowing down the occurrence of memory loss and inability to take care of itself. Baijian suspended trading for nearly 3 hours on Monday morning, and then the resumption of trading was stimulated by positive news, and its stock price once soared by more than 60%.</p><p>Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, noted in a press release:</p><p>We are well aware of how much attention is surrounding this (drug) approval. We can understand that Aduhelm has garnered the attention of the media, the Alzheimer's disease patient community, officials and stakeholders. With treatments for serious and fatal diseases pending, it makes sense that the findings of this review have received much attention. According to the media, Peter Stein, director of the Office of New Drugs under the FDA Center for Drug Evaluation and Research, said that patients are willing to accept uncertainty in order to obtain drugs that can bring obvious benefits in preventing Alzheimer's disease, because everyone knows that this disease will have devastating consequences.</p><p>However, it should be noted that the FDA's approval of Aduhelm is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Biogen are very complex, and there are still uncertainties. Whether Aduhelm should be approved or not has been debated by the public many times, and as usually happens when interpreting scientific data, experts have different views. There are also many scientists who oppose the approval of this drug, saying that it doesn't work.</p><p>The opinion of the opposing party is not without foundation. Some of the performances of the Aduhelm drug in trials were not satisfactory. According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>Biogen suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession, with an intraday increase of 64%, and then it retreated. As of the close, Biogen rose 38.34% to $395.85. The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Biogen's Alzheimer's disease drug was approved by FDA, and its stock soared 64%</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nBiogen's Alzheimer's disease drug was approved by FDA, and its stock soared 64%\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/102\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">老虎资讯综合 </p>\n<p class=\"h-time smaller\">2021-06-08 08:31</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>The U.S. Food and Drug Administration (FDA) approved Biogen's experimental drug aducanumab (trade name: Aduhelm) for the treatment of Alzheimer's disease on Monday, Eastern Time. This is the first time in nearly 20 years that the FDA has approved the treatment of the disease. New drugs. Reuters pointed out in the report that Aduhelm can slow down the course of the patient's disease by removing the sticky deposits in the patient's brain, thereby slowing down the occurrence of memory loss and inability to take care of itself. Baijian suspended trading for nearly 3 hours on Monday morning, and then the resumption of trading was stimulated by positive news, and its stock price once soared by more than 60%.</p><p>Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, noted in a press release:</p><p>We are well aware of how much attention is surrounding this (drug) approval. We can understand that Aduhelm has garnered the attention of the media, the Alzheimer's disease patient community, officials and stakeholders. With treatments for serious and fatal diseases pending, it makes sense that the findings of this review have received much attention. According to the media, Peter Stein, director of the Office of New Drugs under the FDA Center for Drug Evaluation and Research, said that patients are willing to accept uncertainty in order to obtain drugs that can bring obvious benefits in preventing Alzheimer's disease, because everyone knows that this disease will have devastating consequences.</p><p>However, it should be noted that the FDA's approval of Aduhelm is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Biogen are very complex, and there are still uncertainties. Whether Aduhelm should be approved or not has been debated by the public many times, and as usually happens when interpreting scientific data, experts have different views. There are also many scientists who oppose the approval of this drug, saying that it doesn't work.</p><p>The opinion of the opposing party is not without foundation. Some of the performances of the Aduhelm drug in trials were not satisfactory. According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>Biogen suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession, with an intraday increase of 64%, and then it retreated. As of the close, Biogen rose 38.34% to $395.85. The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/c5f6cd84096ca9b3b893fb788b76d134","relate_stocks":{},"is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141258798","content_text":"美国食品和药物管理局（FDA）在美东时间周一批准了百健（Biogen）治疗阿尔茨海默病的试验性药物aducanumab（商品名：Aduhelm），这也是近20年来FDA首次批准治疗该病症的新药。路透社在报道当中指出，Aduhelm可以通过清除患者大脑中的粘性沉积物以减缓患者的病程发展，进而减缓记忆丧失和生活不能自理等情况的发生。百健在周一早间曾停牌近3小时，之后复牌受到利好刺激，股价一度暴涨超60%。FDA药物评估和研究中心主任Patrizia Cavazzoni博士在一份新闻稿中指出：我们很清楚围绕这一（药品）批准有多少关注。我们能够理解Aduhelm获得了媒体，阿尔茨海默病患者群体，官员以及利益相关方的关注。在严重且致命的疾病治疗方法悬而未决的情况下，这次审查的结果受到众多关注是有道理的。据媒体，FDA药物评估和研究中心下属的新药办公室主任Peter Stein表示，病人愿意接受不确定性，以获得在防止阿尔茨海默病方面能带来明显益处的药物，因为大家都知道这种疾病会带来毁灭性的后果。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此FDA在新闻稿当中表示，百健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。Aduhelm应被批准与否早已经过了公众的多次辩论，而且正如同解读科学数据时通常出现的情况，专家方面也有不同观点。也有许多科学家反对批准这一药物，说它不起作用。反对方的意见并非毫无依据。Aduhelm药物在试验中的一些表现不尽如人意。据彭博，在Biogen公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。百健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到64%，而在之后则出现回吐。截至收盘，百健上涨38.34%，报395.85美元。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。市场预计，最新药物的批准将为公司带来数十亿美元的收入。","news_type":1,"symbols_score_info":{}},"isVote":1,"tweetType":1,"viewCount":1328,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":6,"xxTargetLangEnum":"ORIG"},"commentList":[],"hasMoreComment":false,"orderType":2}