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2021-10-12
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PTGX Stock: Why It Substantially Increased Today<blockquote>PTGX股票:为什么今天大幅上涨</blockquote>
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Investors are responding positively to Protagonist Therapeutics announcing that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the company’s rusfertide clinical studies, announced on September 17, 2021. And per the FDA, dosing in all clinical studies of rusfertide may be resumed.</p><p><blockquote>Protagonist Therapeutics Inc(纳斯达克:PTGX)的股价在周一早盘交易中上涨了80%以上。投资者对主角Therapeutics宣布美国美国食品药品监督管理局(FDA)于2021年9月17日宣布,已解除对该公司rusfertide临床研究的全面临床搁置。并且根据FDA,可以恢复所有rusfertide临床研究中的给药。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/7e4bb774f548f6facdd0906f873a43c6\" tg-width=\"840\" tg-height=\"470\" width=\"100%\" height=\"auto\"></p><p><blockquote></blockquote></p><p> Protagonist Therapeutics provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, Protagonist Therapeutics provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. And Protagonist Therapeutics is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.</p><p><blockquote>Protagonist Therapeutics向FDA提供了所有要求的信息,作为完整响应和随后解除临床搁置的基础。特别是,Protagonist Therapeutics提供了所要求的个体患者临床安全性报告,更新了研究者手册和患者知情同意书,对最新的安全性数据库进行了全面审查,并在研究方案中纳入了新的安全性和停药规则。Protagonist Therapeutics正在与研究研究者和临床试验中心密切合作,在患者重新同意后恢复正在进行的rusfertide临床试验中的患者给药。</blockquote></p><p> The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.</p><p><blockquote>临床暂停最初是由最近在26周rasH2转基因小鼠模型中的非临床发现触发的,该发现指示良性和恶性皮下皮肤肿瘤。rasH2信号还促使对涉及160多名患者的所有rusfertide临床试验中观察到的4例癌症病例进行重新检查,并对安全性数据库进行全面审查,包括疑似意外严重不良反应(SUSAR)病例。在此过程中,没有出现额外的癌症病例,也没有其他意外的安全信号。</blockquote></p><p></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>PTGX Stock: Why It Substantially Increased Today<blockquote>PTGX股票:为什么今天大幅上涨</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\">\nPTGX Stock: Why It Substantially Increased Today<blockquote>PTGX股票:为什么今天大幅上涨</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\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-10-11 23:18</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>The stock price of Protagonist Therapeutics Inc (NASDAQ: PTGX) increased by over 80% in Monday morning trading. Investors are responding positively to Protagonist Therapeutics announcing that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the company’s rusfertide clinical studies, announced on September 17, 2021. And per the FDA, dosing in all clinical studies of rusfertide may be resumed.</p><p><blockquote>Protagonist Therapeutics Inc(纳斯达克:PTGX)的股价在周一早盘交易中上涨了80%以上。投资者对主角Therapeutics宣布美国美国食品药品监督管理局(FDA)于2021年9月17日宣布,已解除对该公司rusfertide临床研究的全面临床搁置。并且根据FDA,可以恢复所有rusfertide临床研究中的给药。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/7e4bb774f548f6facdd0906f873a43c6\" tg-width=\"840\" tg-height=\"470\" width=\"100%\" height=\"auto\"></p><p><blockquote></blockquote></p><p> Protagonist Therapeutics provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, Protagonist Therapeutics provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. And Protagonist Therapeutics is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.</p><p><blockquote>Protagonist Therapeutics向FDA提供了所有要求的信息,作为完整响应和随后解除临床搁置的基础。特别是,Protagonist Therapeutics提供了所要求的个体患者临床安全性报告,更新了研究者手册和患者知情同意书,对最新的安全性数据库进行了全面审查,并在研究方案中纳入了新的安全性和停药规则。Protagonist Therapeutics正在与研究研究者和临床试验中心密切合作,在患者重新同意后恢复正在进行的rusfertide临床试验中的患者给药。</blockquote></p><p> The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.</p><p><blockquote>临床暂停最初是由最近在26周rasH2转基因小鼠模型中的非临床发现触发的,该发现指示良性和恶性皮下皮肤肿瘤。rasH2信号还促使对涉及160多名患者的所有rusfertide临床试验中观察到的4例癌症病例进行重新检查,并对安全性数据库进行全面审查,包括疑似意外严重不良反应(SUSAR)病例。在此过程中,没有出现额外的癌症病例,也没有其他意外的安全信号。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PTGX":"Protagonist Therapeutics Inc"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1192053848","content_text":"The stock price of Protagonist Therapeutics Inc (NASDAQ: PTGX) increased by over 80% in Monday morning trading. Investors are responding positively to Protagonist Therapeutics announcing that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the company’s rusfertide clinical studies, announced on September 17, 2021. And per the FDA, dosing in all clinical studies of rusfertide may be resumed.\n\nProtagonist Therapeutics provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, Protagonist Therapeutics provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. And Protagonist Therapeutics is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.\nThe clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.","news_type":1,"symbols_score_info":{"PTGX":0.9}},"isVote":1,"tweetType":1,"viewCount":3543,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":4,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/826642184"}
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