PharmaEssentia Gets US FDA's Approval for Essential Thrombocythemia Treament Drug; Shares Sink 10%

MT Newswires Live

昨天

PharmaEssentia (TPE:6446) has received approval from the US Food and Drug Administration for BESREMi (Ropeginterferon alfa-2b-njft) solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.

The company's shares were down 10% in Monday's trade.

The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.

Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi (ropeginterferon alfa-2b) for essential thrombocythemia in the US.

The US FDA approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of all adults with PV in November 2021.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.0a0bd8dc.png","ogUrl":"https://www.itiger.com/hans/news/2663024641"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2663024641\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2663024641?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-08-31 12:50","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2663024641","market":"hk","top_or_hot":-1,"title":"PharmaEssentia Gets US FDA's Approval for Essential Thrombocythemia Treament Drug; Shares Sink 10%","media":"MT Newswires Live","content":"<html><body><p> PharmaEssentia (TPE:6446) has received approval from the US Food and Drug Administration for BESREMi (Ropeginterferon alfa-2b-njft) solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.</p><p>The company's shares were down 10% in Monday's trade.</p><p>The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.</p><p>Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi (ropeginterferon alfa-2b) for essential thrombocythemia in the US.</p><p>The US FDA approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of all adults with PV in November 2021.</p></body></html>","source":"mtnewswires_news","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>PharmaEssentia Gets US FDA's Approval for Essential Thrombocythemia Treament Drug; Shares Sink 10%</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: 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\">\nPharmaEssentia Gets US FDA's Approval for Essential Thrombocythemia Treament Drug; Shares Sink 10%\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2026-08-31 12:50</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> PharmaEssentia (TPE:6446) has received approval from the US Food and Drug Administration for BESREMi (Ropeginterferon alfa-2b-njft) solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.</p><p>The company's shares were down 10% in Monday's trade.</p><p>The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.</p><p>Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi (ropeginterferon alfa-2b) for essential thrombocythemia in the US.</p><p>The US FDA approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of all adults with PV in November 2021.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LABU","symbol_name":"三倍做多标普生物-Direxion","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2663024641","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2663024641","pubTimestamp":1788151819,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"PharmaEssentia  has received approval from the US Food and Drug Administration for BESREMi  solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.The company's shares were down 10% in Monday's trade.The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi  for essential thrombocythemia in the US.The US FDA approved BESREMi  for the treatment of all adults with PV in November 2021.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LABU":"三倍做多标普生物-Direxion","BK4588":"碎股","BK4585":"ETF&股票定投概念"},"translate_title":"PharmaEssentia获得美国FDA批准基本血小板增多症治疗药物；股价下跌 10%","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LABU":1.5},"content_text":"PharmaEssentia (TPE:6446) has received approval from the US Food and Drug Administration for BESREMi (Ropeginterferon alfa-2b-njft) solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.The company's shares were down 10% in Monday's trade.The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi (ropeginterferon alfa-2b) for essential thrombocythemia in the US.The US FDA approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of all adults with PV in November 2021.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"-1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}