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2021-06-21

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Orphazyme rose more than 6% in premarket trading<blockquote>Orphazyme 在盘前交易中上涨超过 6%</blockquote>

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Investors are now uncertain when the biotech could have an approved product to sell, and pushed the stock 44.4% lower as of 12:12 p.m. EDT on last&nbsp;Friday.<blockquote>股份奥尔法酶在美国食品药品监督管理局 (FDA) 拒绝批准该公司主要候选人的申请后，一家临床阶段的生物制药公司受到了打击。投资者现在不确定这家生物技术公司何时可以销售获得批准的产品，截至美国东部时间中午 12:12，该股下跌 44.4%。上周五美国东部时间。</blockquote> So what<blockquote>那又怎样</blockquote> The FDA began reviewing an application for Orphazyme's lead candidate arimoclomol last September as a potential treatment for a rare but life-threatening disease called Neimann-Pick Disease Type-C (NPC). Earlier this month, shares of Orphazymeshot upmore than 200% in anticipation of a green light that never came.<blockquote>FDA 去年 9 月开始审查 Orphazyme 的主要候选药物 arimoclomol 的申请，作为一种罕见但危及生命的疾病的潜在治疗方法，称为 Neimann-Pick 病 C 型 (NPC)。本月早些时候，Orphazyme 的股价上涨了 200% 以上，原因是预期从未到来的绿灯。</blockquote> Instead of an approval decision for arimoclomol, the agency asked for more information in the form of a complete response letter (CRL). That came as a shock to heaps of investors who were new to the complex world of drug development and were expecting a massiveshort squeeze.<blockquote>该机构没有做出arimoclomol的批准决定，而是以完整回复函（CRL）的形式要求提供更多信息。这让许多投资者感到震惊，他们刚刚接触复杂的药物开发世界，并预计会出现大规模的空头挤压。</blockquote> Many institutional investors were betting against Orphazyme because its lead candidate failed to achieve the primary endpoint in the pivotal study underpinning the application. Arimoclomol also failed to improve patients' scores on a secondary endpoint specifically requested by the FDA.<blockquote>许多机构投资者押注 Orphazyme，因为其主要候选药物未能在支撑该申请的关键研究中实现主要终点。Arimoclomol 也未能改善 FDA 特别要求的次要终点的患者评分。</blockquote> Now what<blockquote>现在呢</blockquote> According to Orphazyme, the company needs to further substantiate the validity of the primary endpoint that arimoclomol almost achieved. To satisfy the FDA, the company will most likely have to run a new pivotal study.<blockquote>据Orphazyme称，该公司需要进一步证实arimoclomol几乎达到的主要终点的有效性。为了满足 FDA 的要求，该公司很可能不得不进行一项新的关键研究。</blockquote> Some shareholders remain hopeful that the European Medicines Agency will be less strict than the FDA. While the FDA's European colleague has been more lenient regarding treatments for rare diseases in the past, arimoclomol probably isn't moving forward until it produces some convincing clinical-trial results.<blockquote>一些股东仍然希望欧洲药品管理局不会像FDA那样严格。虽然FDA的欧洲同事过去在罕见疾病的治疗方面更加宽松，但arimoclomol可能不会向前推进，直到它产生一些令人信服的临床试验结果。</blockquote> Despite lacking a clear path forward, the Denmark-headquartered company still boasts a fairly large market cap in excess of $500 million at recent prices. Irrational expectations could keep it elevated, but this is way too high for anyclinical-stage biotechin Orphazyme's position.<blockquote>尽管缺乏明确的前进道路，这家总部位于丹麦的公司仍然拥有相当大的市值，按最近的价格计算，超过 5 亿美元。非理性的期望可能会使其保持较高水平，但对于任何临床阶段的生物技术公司 Orphazyme 的地位来说，这都太高了。</blockquote>","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>Orphazyme rose more than 6% in premarket trading<blockquote>Orphazyme 在盘前交易中上涨超过 6%</blockquote></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\">\nOrphazyme rose more than 6% in premarket trading<blockquote>Orphazyme 在盘前交易中上涨超过 6%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\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\">\nTiger Newspress \n2021-06-21 17:17\n</div>\n</a>\n</h4>\n</header>\n<article>\n(June 21)&nbsp;Orphazyme rose more than 6% in premarket trading.&nbsp;<blockquote>（6月21日）Orphazyme在盘前交易中上涨超过6%。</blockquote> <img src=\"https://static.tigerbbs.com/a1e2eb27cc68ce74ddd21a64a64634cf\" tg-width=\"719\" tg-height=\"495\" referrerpolicy=\"no-referrer\"><blockquote></blockquote> What happened<blockquote>发生了什么事</blockquote> Shares of&nbsp;Orphazyme, a clinical-stage biopharmaceutical company, got hammered after the Food and Drug Administration (FDA) refused to approve an application for the company's lead candidate. Investors are now uncertain when the biotech could have an approved product to sell, and pushed the stock 44.4% lower as of 12:12 p.m. EDT on last&nbsp;Friday.<blockquote>股份奥尔法酶在美国食品药品监督管理局 (FDA) 拒绝批准该公司主要候选人的申请后，一家临床阶段的生物制药公司受到了打击。投资者现在不确定这家生物技术公司何时可以销售获得批准的产品，截至美国东部时间中午 12:12，该股下跌 44.4%。上周五美国东部时间。</blockquote> So what<blockquote>那又怎样</blockquote> The FDA began reviewing an application for Orphazyme's lead candidate arimoclomol last September as a potential treatment for a rare but life-threatening disease called Neimann-Pick Disease Type-C (NPC). Earlier this month, shares of Orphazymeshot upmore than 200% in anticipation of a green light that never came.<blockquote>FDA 去年 9 月开始审查 Orphazyme 的主要候选药物 arimoclomol 的申请，作为一种罕见但危及生命的疾病的潜在治疗方法，称为 Neimann-Pick 病 C 型 (NPC)。本月早些时候，Orphazyme 的股价上涨了 200% 以上，原因是预期从未到来的绿灯。</blockquote> Instead of an approval decision for arimoclomol, the agency asked for more information in the form of a complete response letter (CRL). That came as a shock to heaps of investors who were new to the complex world of drug development and were expecting a massiveshort squeeze.<blockquote>该机构没有做出arimoclomol的批准决定，而是以完整回复函（CRL）的形式要求提供更多信息。这让许多投资者感到震惊，他们刚刚接触复杂的药物开发世界，并预计会出现大规模的空头挤压。</blockquote> Many institutional investors were betting against Orphazyme because its lead candidate failed to achieve the primary endpoint in the pivotal study underpinning the application. Arimoclomol also failed to improve patients' scores on a secondary endpoint specifically requested by the FDA.<blockquote>许多机构投资者押注 Orphazyme，因为其主要候选药物未能在支撑该申请的关键研究中实现主要终点。Arimoclomol 也未能改善 FDA 特别要求的次要终点的患者评分。</blockquote> Now what<blockquote>现在呢</blockquote> According to Orphazyme, the company needs to further substantiate the validity of the primary endpoint that arimoclomol almost achieved. To satisfy the FDA, the company will most likely have to run a new pivotal study.<blockquote>据Orphazyme称，该公司需要进一步证实arimoclomol几乎达到的主要终点的有效性。为了满足 FDA 的要求，该公司很可能不得不进行一项新的关键研究。</blockquote> Some shareholders remain hopeful that the European Medicines Agency will be less strict than the FDA. While the FDA's European colleague has been more lenient regarding treatments for rare diseases in the past, arimoclomol probably isn't moving forward until it produces some convincing clinical-trial results.<blockquote>一些股东仍然希望欧洲药品管理局不会像FDA那样严格。虽然FDA的欧洲同事过去在罕见疾病的治疗方面更加宽松，但arimoclomol可能不会向前推进，直到它产生一些令人信服的临床试验结果。</blockquote> Despite lacking a clear path forward, the Denmark-headquartered company still boasts a fairly large market cap in excess of $500 million at recent prices. Irrational expectations could keep it elevated, but this is way too high for anyclinical-stage biotechin Orphazyme's position.<blockquote>尽管缺乏明确的前进道路，这家总部位于丹麦的公司仍然拥有相当大的市值，按最近的价格计算，超过 5 亿美元。非理性的期望可能会使其保持较高水平，但对于任何临床阶段的生物技术公司 Orphazyme 的地位来说，这都太高了。</blockquote>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1184501396","content_text":"(June 21) Orphazyme rose more than 6% in premarket trading. \n\nWhat happened\nShares of Orphazyme, a clinical-stage biopharmaceutical company, got hammered after the Food and Drug Administration (FDA) refused to approve an application for the company's lead candidate. Investors are now uncertain when the biotech could have an approved product to sell, and pushed the stock 44.4% lower as of 12:12 p.m. EDT on last Friday.\nSo what\nThe FDA began reviewing an application for Orphazyme's lead candidate arimoclomol last September as a potential treatment for a rare but life-threatening disease called Neimann-Pick Disease Type-C (NPC). Earlier this month, shares of Orphazymeshot upmore than 200% in anticipation of a green light that never came.\nInstead of an approval decision for arimoclomol, the agency asked for more information in the form of a complete response letter (CRL). That came as a shock to heaps of investors who were new to the complex world of drug development and were expecting a massiveshort squeeze.\nMany institutional investors were betting against Orphazyme because its lead candidate failed to achieve the primary endpoint in the pivotal study underpinning the application. Arimoclomol also failed to improve patients' scores on a secondary endpoint specifically requested by the FDA.\nNow what\nAccording to Orphazyme, the company needs to further substantiate the validity of the primary endpoint that arimoclomol almost achieved. To satisfy the FDA, the company will most likely have to run a new pivotal study.\nSome shareholders remain hopeful that the European Medicines Agency will be less strict than the FDA. While the FDA's European colleague has been more lenient regarding treatments for rare diseases in the past, arimoclomol probably isn't moving forward until it produces some convincing clinical-trial results.\nDespite lacking a clear path forward, the Denmark-headquartered company still boasts a fairly large market cap in excess of $500 million at recent prices. Irrational expectations could keep it elevated, but this is way too high for anyclinical-stage biotechin Orphazyme's position.","news_type":1,"symbols_score_info":{"ORPH":0.9}},"isVote":1,"tweetType":1,"viewCount":1231,"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":4,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/167534562"}