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2021-10-05
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Orphazyme provides regulatory update on arimoclomol, raises cash guidance
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ORPH now anticipates a CHMP opinion in Q1 2022 compared to previous Q4 2021.</li>\n <li>In U.S., the company requested and has been granted a Post-Action Type A meeting with the FDA, which has been scheduled for mid-October.</li>\n <li>At this meeting, Orphazyme plans to engage in a dialogue with the FDA to better understand its decision in theComplete Response Letter issued in June 2021, as well as to discuss proposals to address key topics raised in the letter.</li>\n <li>Also, the company has updated cash guidance and now expects to end 2021 with a cash position of DKK 80M compared to prior outlook of ~DKK 50M.</li>\n <li>The improved guidance relates to the ongoing restructuring plan, which has enabled the company to deliver more than anticipated savings in terms of headcount and other costs.</li>\n</ul>","source":"seekingalpha","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 provides regulatory update on arimoclomol, raises cash guidance</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; 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}\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: 11px; color: #7E829C; margin: 0;line-height: 11px;}\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 provides regulatory update on arimoclomol, raises cash guidance\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-10-05 17:59 GMT+8 <a href=https://seekingalpha.com/news/3748882-orphazyme-provides-regulatory-update-on-arimoclomol-raises-cash-guidance><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Orphazyme A/S(NASDAQ:ORPH)announces regulatory updates for arimoclomol, for which it is seeking marketing authorization in both Europe and U.S. for the treatment of Niemann-Pick disease Type C.\nShares...</p>\n\n<a href=\"https://seekingalpha.com/news/3748882-orphazyme-provides-regulatory-update-on-arimoclomol-raises-cash-guidance\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://seekingalpha.com/news/3748882-orphazyme-provides-regulatory-update-on-arimoclomol-raises-cash-guidance","is_english":true,"share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","article_id":"1124184351","content_text":"Orphazyme A/S(NASDAQ:ORPH)announces regulatory updates for arimoclomol, for which it is seeking marketing authorization in both Europe and U.S. for the treatment of Niemann-Pick disease Type C.\nShares up 1.5% premarket at $4.07.\nThe review process in Europe is underway. 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