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zuhdi
zuhdi
·
2021-11-29
Really?
Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>
Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets o
Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>
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zuhdi
zuhdi
·
2021-11-29
Wtf
Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>
Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets o
Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>
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zuhdi
zuhdi
·
2021-11-20
Good
非常抱歉,此主贴已删除
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zuhdi
zuhdi
·
2021-11-10
$Shutterstock(SSTK)$
up and down
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zuhdi
zuhdi
·
2021-11-10
$NIO Inc.(NIO)$
not bad
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zuhdi
zuhdi
·
2021-09-18
He deserved it
Wall Street Crime And Punishment: Dennis Kozlowski, Tyco International's Big-Spending Vulgarian<blockquote>华尔街罪与罚:丹尼斯·科兹洛夫斯基,泰科国际的大手笔庸俗</blockquote>
Does crime pay? Wall Street Crime and Punishment is a weekly series by Benzinga's Phil Hall chronicl
Wall Street Crime And Punishment: Dennis Kozlowski, Tyco International's Big-Spending Vulgarian<blockquote>华尔街罪与罚:丹尼斯·科兹洛夫斯基,泰科国际的大手笔庸俗</blockquote>
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","listText":"Really? ","text":"Really?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/600714645","repostId":"1164587624","repostType":4,"repost":{"id":"1164587624","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1638195795,"share":"https://www.laohu8.com/m/news/1164587624?lang=zh_CN&edition=full","pubTime":"2021-11-29 22:23","market":"us","language":"en","title":"Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1164587624","media":"Tiger Newspress","summary":"Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets o","content":"<p>Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.</p><p><blockquote>在营养不良EB试验达到目标后,Krystal Biotech Inc.的股价在盘前交易中上涨了一倍多。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/9a6cac27a6ef602da5ab0bfd20f69c16\" tg-width=\"852\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> Krystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).</p><p><blockquote>罕见疾病可重复剂量基因疗法的领导者郑秀晶生物技术公司今天宣布了研究性beremagene geperpavec(B-VEC)(现称为VYJUVEKTM)治疗营养不良性大疱性表皮松解症(营养不良性EB)的关键GEM-3试验的积极顶线结果。</blockquote></p><p> The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.</p><p><blockquote>该试验的主要终点评估了与安慰剂相比,局部VYJUVEKTM在六个月时间点的伤口完全愈合情况,并符合统计学显著性。VYJUVEKTMis是第一种正在开发的非侵入性、局部和可重复给药的基因疗法,也是唯一一种成功完成双盲3期试验的治疗营养不良型EB的基因矫正方法。</blockquote></p><p> <b>Highlights of Topline Results from the GEM-3 Trial</b></p><p><blockquote><b>GEM-3试验的主要结果要点</b></blockquote></p><p> <ul> <li>31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis</li> <li>67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)</li> <li>71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)</li> <li>In an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)</li> </ul> <ul> <li>VYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.</li> <li>The immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies</li> </ul> “Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”</p><p><blockquote><ul><li>根据主要意向治疗(ITT)分析,纳入了31例患者(31对主要匹配伤口)并可评估安全性和有效性</li><li>67%接受VYJUVEKTMA治疗的伤口在6个月时间点达到研究者评估的伤口完全愈合的主要终点,而接受安慰剂治疗的伤口为22%(绝对差异(95%CI):45.8%(23.6%-68.0%);p<0.005)</li><li>71%接受VYJUVEKTMA治疗的伤口在3个月时间点达到研究者评估的伤口完全愈合的次要终点,而接受安慰剂治疗的伤口为20%(绝对差异(95%CI):51.0%(29.3%-72.6%);p<0.005)</li><li>在一项特别分析中,该试验还证明了活性组和安慰剂组在3个月和6个月时间点伤口完全愈合的伤口之间存在统计学差异(p<0.005)</li></ul><ul><li>VYJUVEKTM耐受性良好。未报告与药物相关的严重不良事件或因治疗而停药。试验期间报告了1起轻度药物相关不良事件。</li><li>VYJUVEKTM的免疫原性特征(通过抗HSV-1和抗COL7抗体测量)与先前的GEM-1/2研究一致,在先前的GEM-1/2研究中,我们没有观察到抗HSV-1或抗COL7抗体有意义的变化</li></ul>“营养不良性大疱性表皮松解症被称为‘你从未听说过的最严重的疾病’,因为患有这种遗传疾病的患者面临着令人难以置信的毁灭性现实,我们很高兴宣布我们的关键GEM-3试验VyjuvekTM的积极结果表明,这种局部基因疗法可以使营养不良性EB伤口持久愈合,”Krystal创始人兼首席运营官Suma Krishnan说道。“有了这些结果,我们期待与监管机构推进讨论,并将迅速努力,将这种潜在的首次治疗方法带给急需的营养不良型EB患者及其家人。”</blockquote></p><p> “Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.</p><p><blockquote>“今天的B-VEC阳性结果代表了多年来对这种疾病的分子基础和基因矫正研究的高潮。最后,营养不良型EB患者可能有一种易于管理的基因靶向疗法,该疗法已被证明可以促进持久的伤口愈合。对于患有这种疾病的患者来说,这是一个姗姗来迟的里程碑,也有可能彻底改变治疗范式,”斯坦福大学大疱性疾病诊所主任兼皮肤病学副教授Peter Marinkovich医学博士说。</blockquote></p><p> <b>Next Steps</b></p><p><blockquote><b>后续步骤</b></blockquote></p><p> Based on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.</p><p><blockquote>基于这些结果,Krystal打算向美国提交生物制品许可申请(BLA)。美国食品和药物管理局(FDA)将于2022年上半年作为执行其全球监管和商业化战略的第一步,将这种研究疗法带给有需要的患者。该公司预计将在BLA后不久在欧洲提交营销授权申请(MAA)。正在探索包括日本在内的其他地区的潜在监管路径。Krystal将继续在其内部cGMP制造工厂ANCORIS采用商业规模工艺生产Vyjuvektmus,该工厂旨在支持潜在的发布。该公司目前正在建设第二个更大的设施ASTRA,预计将于2022年上线,以帮助支持潜在的全球发布和管道。</blockquote></p><p></p><p> “We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”</p><p><blockquote>“不到六年前,我们创立了Krystal,目标是开发一种针对营养不良型EB的非侵入性基因矫正疗法。我们向患者、护理人员、研究人员,当然还有更广泛的Krystal团队表示最深切的感谢,他们不知疲倦地工作帮助我们在VyjuveKTM计划的进展中达到这一激动人心的时刻,”Krystal董事长兼首席执行官Krish Krishnan说道。“这些关键数据为我们的可重复剂量基因递送技术提供了重要验证,使我们有勇气扩大我们的管道以解决其他遗传性皮肤病,继续探索遗传性肺病的潜力,并投资提高解决新器官系统的平台能力以及。”</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>Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</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; 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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: 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\">\nKrystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</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\">2021-11-29 22:23</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.</p><p><blockquote>在营养不良EB试验达到目标后,Krystal Biotech Inc.的股价在盘前交易中上涨了一倍多。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/9a6cac27a6ef602da5ab0bfd20f69c16\" tg-width=\"852\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> Krystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).</p><p><blockquote>罕见疾病可重复剂量基因疗法的领导者郑秀晶生物技术公司今天宣布了研究性beremagene geperpavec(B-VEC)(现称为VYJUVEKTM)治疗营养不良性大疱性表皮松解症(营养不良性EB)的关键GEM-3试验的积极顶线结果。</blockquote></p><p> The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.</p><p><blockquote>该试验的主要终点评估了与安慰剂相比,局部VYJUVEKTM在六个月时间点的伤口完全愈合情况,并符合统计学显著性。VYJUVEKTMis是第一种正在开发的非侵入性、局部和可重复给药的基因疗法,也是唯一一种成功完成双盲3期试验的治疗营养不良型EB的基因矫正方法。</blockquote></p><p> <b>Highlights of Topline Results from the GEM-3 Trial</b></p><p><blockquote><b>GEM-3试验的主要结果要点</b></blockquote></p><p> <ul> <li>31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis</li> <li>67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)</li> <li>71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)</li> <li>In an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)</li> </ul> <ul> <li>VYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.</li> <li>The immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies</li> </ul> “Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”</p><p><blockquote><ul><li>根据主要意向治疗(ITT)分析,纳入了31例患者(31对主要匹配伤口)并可评估安全性和有效性</li><li>67%接受VYJUVEKTMA治疗的伤口在6个月时间点达到研究者评估的伤口完全愈合的主要终点,而接受安慰剂治疗的伤口为22%(绝对差异(95%CI):45.8%(23.6%-68.0%);p<0.005)</li><li>71%接受VYJUVEKTMA治疗的伤口在3个月时间点达到研究者评估的伤口完全愈合的次要终点,而接受安慰剂治疗的伤口为20%(绝对差异(95%CI):51.0%(29.3%-72.6%);p<0.005)</li><li>在一项特别分析中,该试验还证明了活性组和安慰剂组在3个月和6个月时间点伤口完全愈合的伤口之间存在统计学差异(p<0.005)</li></ul><ul><li>VYJUVEKTM耐受性良好。未报告与药物相关的严重不良事件或因治疗而停药。试验期间报告了1起轻度药物相关不良事件。</li><li>VYJUVEKTM的免疫原性特征(通过抗HSV-1和抗COL7抗体测量)与先前的GEM-1/2研究一致,在先前的GEM-1/2研究中,我们没有观察到抗HSV-1或抗COL7抗体有意义的变化</li></ul>“营养不良性大疱性表皮松解症被称为‘你从未听说过的最严重的疾病’,因为患有这种遗传疾病的患者面临着令人难以置信的毁灭性现实,我们很高兴宣布我们的关键GEM-3试验VyjuvekTM的积极结果表明,这种局部基因疗法可以使营养不良性EB伤口持久愈合,”Krystal创始人兼首席运营官Suma Krishnan说道。“有了这些结果,我们期待与监管机构推进讨论,并将迅速努力,将这种潜在的首次治疗方法带给急需的营养不良型EB患者及其家人。”</blockquote></p><p> “Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.</p><p><blockquote>“今天的B-VEC阳性结果代表了多年来对这种疾病的分子基础和基因矫正研究的高潮。最后,营养不良型EB患者可能有一种易于管理的基因靶向疗法,该疗法已被证明可以促进持久的伤口愈合。对于患有这种疾病的患者来说,这是一个姗姗来迟的里程碑,也有可能彻底改变治疗范式,”斯坦福大学大疱性疾病诊所主任兼皮肤病学副教授Peter Marinkovich医学博士说。</blockquote></p><p> <b>Next Steps</b></p><p><blockquote><b>后续步骤</b></blockquote></p><p> Based on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.</p><p><blockquote>基于这些结果,Krystal打算向美国提交生物制品许可申请(BLA)。美国食品和药物管理局(FDA)将于2022年上半年作为执行其全球监管和商业化战略的第一步,将这种研究疗法带给有需要的患者。该公司预计将在BLA后不久在欧洲提交营销授权申请(MAA)。正在探索包括日本在内的其他地区的潜在监管路径。Krystal将继续在其内部cGMP制造工厂ANCORIS采用商业规模工艺生产Vyjuvektmus,该工厂旨在支持潜在的发布。该公司目前正在建设第二个更大的设施ASTRA,预计将于2022年上线,以帮助支持潜在的全球发布和管道。</blockquote></p><p></p><p> “We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”</p><p><blockquote>“不到六年前,我们创立了Krystal,目标是开发一种针对营养不良型EB的非侵入性基因矫正疗法。我们向患者、护理人员、研究人员,当然还有更广泛的Krystal团队表示最深切的感谢,他们不知疲倦地工作帮助我们在VyjuveKTM计划的进展中达到这一激动人心的时刻,”Krystal董事长兼首席执行官Krish Krishnan说道。“这些关键数据为我们的可重复剂量基因递送技术提供了重要验证,使我们有勇气扩大我们的管道以解决其他遗传性皮肤病,继续探索遗传性肺病的潜力,并投资提高解决新器官系统的平台能力以及。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"KRYS":"Krystal Biotech Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1164587624","content_text":"Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.\n\nKrystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).\nThe primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.\nHighlights of Topline Results from the GEM-3 Trial\n\n31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis\n67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)\n71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)\nIn an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)\n\n\nVYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.\nThe immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies\n\n“Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”\n“Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.\nNext Steps\nBased on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.\n“We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”","news_type":1,"symbols_score_info":{"KRYS":0.9}},"isVote":1,"tweetType":1,"viewCount":2410,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":600715205,"gmtCreate":1638197588671,"gmtModify":1638198048211,"author":{"id":"4088118027954640","authorId":"4088118027954640","name":"zuhdi","avatar":"https://static.tigerbbs.com/43644b6987b7d82d1a0e634fa59ca435","crmLevel":12,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4088118027954640","idStr":"4088118027954640"},"themes":[],"htmlText":"Wtf","listText":"Wtf","text":"Wtf","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/600715205","repostId":"1164587624","repostType":4,"repost":{"id":"1164587624","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1638195795,"share":"https://www.laohu8.com/m/news/1164587624?lang=zh_CN&edition=full","pubTime":"2021-11-29 22:23","market":"us","language":"en","title":"Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1164587624","media":"Tiger Newspress","summary":"Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets o","content":"<p>Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.</p><p><blockquote>在营养不良EB试验达到目标后,Krystal Biotech Inc.的股价在盘前交易中上涨了一倍多。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/9a6cac27a6ef602da5ab0bfd20f69c16\" tg-width=\"852\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> Krystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).</p><p><blockquote>罕见疾病可重复剂量基因疗法的领导者郑秀晶生物技术公司今天宣布了研究性beremagene geperpavec(B-VEC)(现称为VYJUVEKTM)治疗营养不良性大疱性表皮松解症(营养不良性EB)的关键GEM-3试验的积极顶线结果。</blockquote></p><p> The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.</p><p><blockquote>该试验的主要终点评估了与安慰剂相比,局部VYJUVEKTM在六个月时间点的伤口完全愈合情况,并符合统计学显著性。VYJUVEKTMis是第一种正在开发的非侵入性、局部和可重复给药的基因疗法,也是唯一一种成功完成双盲3期试验的治疗营养不良型EB的基因矫正方法。</blockquote></p><p> <b>Highlights of Topline Results from the GEM-3 Trial</b></p><p><blockquote><b>GEM-3试验的主要结果要点</b></blockquote></p><p> <ul> <li>31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis</li> <li>67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)</li> <li>71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)</li> <li>In an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)</li> </ul> <ul> <li>VYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.</li> <li>The immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies</li> </ul> “Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”</p><p><blockquote><ul><li>根据主要意向治疗(ITT)分析,纳入了31例患者(31对主要匹配伤口)并可评估安全性和有效性</li><li>67%接受VYJUVEKTMA治疗的伤口在6个月时间点达到研究者评估的伤口完全愈合的主要终点,而接受安慰剂治疗的伤口为22%(绝对差异(95%CI):45.8%(23.6%-68.0%);p<0.005)</li><li>71%接受VYJUVEKTMA治疗的伤口在3个月时间点达到研究者评估的伤口完全愈合的次要终点,而接受安慰剂治疗的伤口为20%(绝对差异(95%CI):51.0%(29.3%-72.6%);p<0.005)</li><li>在一项特别分析中,该试验还证明了活性组和安慰剂组在3个月和6个月时间点伤口完全愈合的伤口之间存在统计学差异(p<0.005)</li></ul><ul><li>VYJUVEKTM耐受性良好。未报告与药物相关的严重不良事件或因治疗而停药。试验期间报告了1起轻度药物相关不良事件。</li><li>VYJUVEKTM的免疫原性特征(通过抗HSV-1和抗COL7抗体测量)与先前的GEM-1/2研究一致,在先前的GEM-1/2研究中,我们没有观察到抗HSV-1或抗COL7抗体有意义的变化</li></ul>“营养不良性大疱性表皮松解症被称为‘你从未听说过的最严重的疾病’,因为患有这种遗传疾病的患者面临着令人难以置信的毁灭性现实,我们很高兴宣布我们的关键GEM-3试验VyjuvekTM的积极结果表明,这种局部基因疗法可以使营养不良性EB伤口持久愈合,”Krystal创始人兼首席运营官Suma Krishnan说道。“有了这些结果,我们期待与监管机构推进讨论,并将迅速努力,将这种潜在的首次治疗方法带给急需的营养不良型EB患者及其家人。”</blockquote></p><p> “Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.</p><p><blockquote>“今天的B-VEC阳性结果代表了多年来对这种疾病的分子基础和基因矫正研究的高潮。最后,营养不良型EB患者可能有一种易于管理的基因靶向疗法,该疗法已被证明可以促进持久的伤口愈合。对于患有这种疾病的患者来说,这是一个姗姗来迟的里程碑,也有可能彻底改变治疗范式,”斯坦福大学大疱性疾病诊所主任兼皮肤病学副教授Peter Marinkovich医学博士说。</blockquote></p><p> <b>Next Steps</b></p><p><blockquote><b>后续步骤</b></blockquote></p><p> Based on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.</p><p><blockquote>基于这些结果,Krystal打算向美国提交生物制品许可申请(BLA)。美国食品和药物管理局(FDA)将于2022年上半年作为执行其全球监管和商业化战略的第一步,将这种研究疗法带给有需要的患者。该公司预计将在BLA后不久在欧洲提交营销授权申请(MAA)。正在探索包括日本在内的其他地区的潜在监管路径。Krystal将继续在其内部cGMP制造工厂ANCORIS采用商业规模工艺生产Vyjuvektmus,该工厂旨在支持潜在的发布。该公司目前正在建设第二个更大的设施ASTRA,预计将于2022年上线,以帮助支持潜在的全球发布和管道。</blockquote></p><p></p><p> “We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”</p><p><blockquote>“不到六年前,我们创立了Krystal,目标是开发一种针对营养不良型EB的非侵入性基因矫正疗法。我们向患者、护理人员、研究人员,当然还有更广泛的Krystal团队表示最深切的感谢,他们不知疲倦地工作帮助我们在VyjuveKTM计划的进展中达到这一激动人心的时刻,”Krystal董事长兼首席执行官Krish Krishnan说道。“这些关键数据为我们的可重复剂量基因递送技术提供了重要验证,使我们有勇气扩大我们的管道以解决其他遗传性皮肤病,继续探索遗传性肺病的潜力,并投资提高解决新器官系统的平台能力以及。”</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>Krystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</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; 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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: 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\">\nKrystal Biotech shares Skyrocketed 140% in premarket trading<blockquote>Krystal Biotech股价在盘前交易中飙升140%</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\">2021-11-29 22:23</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.</p><p><blockquote>在营养不良EB试验达到目标后,Krystal Biotech Inc.的股价在盘前交易中上涨了一倍多。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/9a6cac27a6ef602da5ab0bfd20f69c16\" tg-width=\"852\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> Krystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).</p><p><blockquote>罕见疾病可重复剂量基因疗法的领导者郑秀晶生物技术公司今天宣布了研究性beremagene geperpavec(B-VEC)(现称为VYJUVEKTM)治疗营养不良性大疱性表皮松解症(营养不良性EB)的关键GEM-3试验的积极顶线结果。</blockquote></p><p> The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.</p><p><blockquote>该试验的主要终点评估了与安慰剂相比,局部VYJUVEKTM在六个月时间点的伤口完全愈合情况,并符合统计学显著性。VYJUVEKTMis是第一种正在开发的非侵入性、局部和可重复给药的基因疗法,也是唯一一种成功完成双盲3期试验的治疗营养不良型EB的基因矫正方法。</blockquote></p><p> <b>Highlights of Topline Results from the GEM-3 Trial</b></p><p><blockquote><b>GEM-3试验的主要结果要点</b></blockquote></p><p> <ul> <li>31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis</li> <li>67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)</li> <li>71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)</li> <li>In an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)</li> </ul> <ul> <li>VYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.</li> <li>The immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies</li> </ul> “Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”</p><p><blockquote><ul><li>根据主要意向治疗(ITT)分析,纳入了31例患者(31对主要匹配伤口)并可评估安全性和有效性</li><li>67%接受VYJUVEKTMA治疗的伤口在6个月时间点达到研究者评估的伤口完全愈合的主要终点,而接受安慰剂治疗的伤口为22%(绝对差异(95%CI):45.8%(23.6%-68.0%);p<0.005)</li><li>71%接受VYJUVEKTMA治疗的伤口在3个月时间点达到研究者评估的伤口完全愈合的次要终点,而接受安慰剂治疗的伤口为20%(绝对差异(95%CI):51.0%(29.3%-72.6%);p<0.005)</li><li>在一项特别分析中,该试验还证明了活性组和安慰剂组在3个月和6个月时间点伤口完全愈合的伤口之间存在统计学差异(p<0.005)</li></ul><ul><li>VYJUVEKTM耐受性良好。未报告与药物相关的严重不良事件或因治疗而停药。试验期间报告了1起轻度药物相关不良事件。</li><li>VYJUVEKTM的免疫原性特征(通过抗HSV-1和抗COL7抗体测量)与先前的GEM-1/2研究一致,在先前的GEM-1/2研究中,我们没有观察到抗HSV-1或抗COL7抗体有意义的变化</li></ul>“营养不良性大疱性表皮松解症被称为‘你从未听说过的最严重的疾病’,因为患有这种遗传疾病的患者面临着令人难以置信的毁灭性现实,我们很高兴宣布我们的关键GEM-3试验VyjuvekTM的积极结果表明,这种局部基因疗法可以使营养不良性EB伤口持久愈合,”Krystal创始人兼首席运营官Suma Krishnan说道。“有了这些结果,我们期待与监管机构推进讨论,并将迅速努力,将这种潜在的首次治疗方法带给急需的营养不良型EB患者及其家人。”</blockquote></p><p> “Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.</p><p><blockquote>“今天的B-VEC阳性结果代表了多年来对这种疾病的分子基础和基因矫正研究的高潮。最后,营养不良型EB患者可能有一种易于管理的基因靶向疗法,该疗法已被证明可以促进持久的伤口愈合。对于患有这种疾病的患者来说,这是一个姗姗来迟的里程碑,也有可能彻底改变治疗范式,”斯坦福大学大疱性疾病诊所主任兼皮肤病学副教授Peter Marinkovich医学博士说。</blockquote></p><p> <b>Next Steps</b></p><p><blockquote><b>后续步骤</b></blockquote></p><p> Based on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.</p><p><blockquote>基于这些结果,Krystal打算向美国提交生物制品许可申请(BLA)。美国食品和药物管理局(FDA)将于2022年上半年作为执行其全球监管和商业化战略的第一步,将这种研究疗法带给有需要的患者。该公司预计将在BLA后不久在欧洲提交营销授权申请(MAA)。正在探索包括日本在内的其他地区的潜在监管路径。Krystal将继续在其内部cGMP制造工厂ANCORIS采用商业规模工艺生产Vyjuvektmus,该工厂旨在支持潜在的发布。该公司目前正在建设第二个更大的设施ASTRA,预计将于2022年上线,以帮助支持潜在的全球发布和管道。</blockquote></p><p></p><p> “We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”</p><p><blockquote>“不到六年前,我们创立了Krystal,目标是开发一种针对营养不良型EB的非侵入性基因矫正疗法。我们向患者、护理人员、研究人员,当然还有更广泛的Krystal团队表示最深切的感谢,他们不知疲倦地工作帮助我们在VyjuveKTM计划的进展中达到这一激动人心的时刻,”Krystal董事长兼首席执行官Krish Krishnan说道。“这些关键数据为我们的可重复剂量基因递送技术提供了重要验证,使我们有勇气扩大我们的管道以解决其他遗传性皮肤病,继续探索遗传性肺病的潜力,并投资提高解决新器官系统的平台能力以及。”</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"KRYS":"Krystal Biotech Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1164587624","content_text":"Krystal Biotech Inc. shares more than doubled in premarket trading after Dystrophic EB trial meets objectives.\n\nKrystal Biotech, Inc.,, the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).\nThe primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTMcompared to placebo at six-month timepoints and met statistical significance. VYJUVEKTMis the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.\nHighlights of Topline Results from the GEM-3 Trial\n\n31 patients (31 primary matched-wound pairs) were enrolled and evaluable for safety and efficacy per the primary intent-to-treat (ITT) analysis\n67% of wounds treated with VYJUVEKTMachieved the primary endpoint of investigator assessed complete wound healing at the six-month timepoints as compared to 22% of wounds treated with placebo (absolute difference (95% CI): 45.8% (23.6%-68.0%); p<0.005)\n71% of wounds treated with VYJUVEKTMachieved the secondary endpoint of investigator assessed complete wound healing at the three-month timepoints as compared to 20% of wounds treated with placebo (absolute difference (95% CI): 51.0% (29.3%-72.6%); p<0.005)\nIn an ad-hoc analysis, the trial also demonstrated a statistical difference between the active and placebo groups for wounds that demonstrated complete wound healing at both the three- and six-month timepoints (p<0.005)\n\n\nVYJUVEKTMwas well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported. One mild drug-related adverse event was reported during the trial.\nThe immunogenicity profile of VYJUVEKTM(as measured by anti-HSV-1 and anti-COL7 antibodies) was consistent with the prior GEM-1/2 study where we observed no meaningful change in anti-HSV-1 or anti-COL7 antibodies\n\n“Dystrophic Epidermolysis Bullosa is referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face, and we are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTMwhich showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”\n“Today’s positive B-VEC results represent the culmination of years of study on the molecular basis and genetic correction of this disease. Finally, dystrophic EB patients may have an easily administered genetically targeted therapy which has been shown to promote durable wound healing in this clinical trial. This is a long overdue milestone for patients living with this disease, and one that has potential to drastically change the treatment paradigm,” said Dr. Peter Marinkovich, M.D., Bullous Disease Clinic Director and Associate Professor of Dermatology at Stanford University.\nNext Steps\nBased on these results, Krystal intends to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2022 as the first step in executing its global regulatory and commercialization strategy to bring this investigational therapy to patients in need. The Company expects to submit a Marketing Authorization Application (MAA) in Europe shortly after the BLA. Exploration of the potential regulatory path forward in other geographies, including Japan, is underway. Krystal will continue to manufacture VYJUVEKTMusing the commercial scale process at its in-house cGMP manufacturing facility, ANCORIS, which was designed to support potential launch. The Company is currently constructing its second, larger, facility ASTRA, which is expected to come on-line in 2022 to help support a potential global launch and the pipeline.\n“We founded Krystal less than six years ago with the goal of developing a non-invasive, genetically corrective therapy for dystrophic EB. We offer our deepest gratitude to the patients, caregivers, investigators, and of course to the broader Krystal team who worked tirelessly to help us reach this exciting moment in the progression of the VYJUVEKTMprogram,” said Krish Krishnan, Chairman and CEO of Krystal. “These pivotal data provide important validation of our redosable gene delivery technology, emboldening us to expand our pipeline to address other genetic skin diseases, continue to explore the potential in genetic lung diseases, and invest in growing the platform capability to address new organ systems as well.”","news_type":1,"symbols_score_info":{"KRYS":0.9}},"isVote":1,"tweetType":1,"viewCount":2365,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":876765176,"gmtCreate":1637366675881,"gmtModify":1637366675951,"author":{"id":"4088118027954640","authorId":"4088118027954640","name":"zuhdi","avatar":"https://static.tigerbbs.com/43644b6987b7d82d1a0e634fa59ca435","crmLevel":12,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4088118027954640","idStr":"4088118027954640"},"themes":[],"htmlText":"Good","listText":"Good","text":"Good","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/876765176","repostId":"2184184472","repostType":4,"isVote":1,"tweetType":1,"viewCount":2154,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":847977870,"gmtCreate":1636477891505,"gmtModify":1636477891621,"author":{"id":"4088118027954640","authorId":"4088118027954640","name":"zuhdi","avatar":"https://static.tigerbbs.com/43644b6987b7d82d1a0e634fa59ca435","crmLevel":12,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4088118027954640","idStr":"4088118027954640"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/SSTK\">$Shutterstock(SSTK)$</a>up and down","listText":"<a href=\"https://laohu8.com/S/SSTK\">$Shutterstock(SSTK)$</a>up and down","text":"$Shutterstock(SSTK)$up and down","images":[{"img":"https://static.tigerbbs.com/7ae6ec99d7d013ff628c2ae2769affab","width":"1080","height":"1920"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/847977870","isVote":1,"tweetType":1,"viewCount":3160,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":847975298,"gmtCreate":1636477596239,"gmtModify":1636477667680,"author":{"id":"4088118027954640","authorId":"4088118027954640","name":"zuhdi","avatar":"https://static.tigerbbs.com/43644b6987b7d82d1a0e634fa59ca435","crmLevel":12,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4088118027954640","idStr":"4088118027954640"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NIO\">$NIO Inc.(NIO)$</a>not bad","listText":"<a href=\"https://laohu8.com/S/NIO\">$NIO Inc.(NIO)$</a>not bad","text":"$NIO Inc.(NIO)$not bad","images":[{"img":"https://static.tigerbbs.com/6caa940cf6bbdf042dcece8e9e4b5449","width":"1080","height":"1920"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/847975298","isVote":1,"tweetType":1,"viewCount":2367,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":887085837,"gmtCreate":1631944916629,"gmtModify":1632805147926,"author":{"id":"4088118027954640","authorId":"4088118027954640","name":"zuhdi","avatar":"https://static.tigerbbs.com/43644b6987b7d82d1a0e634fa59ca435","crmLevel":12,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4088118027954640","idStr":"4088118027954640"},"themes":[],"htmlText":"He deserved it","listText":"He deserved it","text":"He deserved it","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/887085837","repostId":"1132017913","repostType":4,"repost":{"id":"1132017913","kind":"news","pubTimestamp":1631921413,"share":"https://www.laohu8.com/m/news/1132017913?lang=zh_CN&edition=full","pubTime":"2021-09-18 07:30","market":"us","language":"en","title":"Wall Street Crime And Punishment: Dennis Kozlowski, Tyco International's Big-Spending Vulgarian<blockquote>华尔街罪与罚:丹尼斯·科兹洛夫斯基,泰科国际的大手笔庸俗</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1132017913","media":"Benzinga","summary":"Does crime pay?\nWall Street Crime and Punishment is a weekly series by Benzinga's Phil Hall chronicl","content":"<p><div> Does crime pay? Wall Street Crime and Punishment is a weekly series by Benzinga's Phil Hall chronicling the bankers, brokers and financial ne’er-do-wells whose ambition and greed take them in the ...</p><p><blockquote><div>犯罪有代价吗?《华尔街犯罪与惩罚》是本津加的菲尔霍尔周刊系列,记录了银行家、经纪人和金融非赢利者,他们的野心和贪婪将他们带入了...</div></blockquote></p><p> <a href=\"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian\">网页链接</a> </div> </p><p><blockquote><a href=\"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian\">网页连接</a></blockquote></p><p></p>","source":"lsy1606299360108","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>Wall Street Crime And Punishment: Dennis Kozlowski, Tyco International's Big-Spending Vulgarian<blockquote>华尔街罪与罚:丹尼斯·科兹洛夫斯基,泰科国际的大手笔庸俗</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\">\nWall Street Crime And Punishment: Dennis Kozlowski, Tyco International's Big-Spending Vulgarian<blockquote>华尔街罪与罚:丹尼斯·科兹洛夫斯基,泰科国际的大手笔庸俗</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Benzinga</strong><span class=\"h-time small\">2021-09-18 07:30</span>\n</p>\n</h4>\n</header>\n<article>\n<p><div> Does crime pay? Wall Street Crime and Punishment is a weekly series by Benzinga's Phil Hall chronicling the bankers, brokers and financial ne’er-do-wells whose ambition and greed take them in the ...</p><p><blockquote><div>犯罪有代价吗?《华尔街犯罪与惩罚》是本津加的菲尔霍尔周刊系列,记录了银行家、经纪人和金融非赢利者,他们的野心和贪婪将他们带入了...</div></blockquote></p><p> <a href=\"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian\">网页链接</a> </div> </p><p><blockquote><a href=\"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian\">网页连接</a></blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源:<a href=\"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian\">Benzinga</a></p>\n<p>为提升您的阅读体验,我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://www.benzinga.com/news/21/09/22976498/wall-street-crime-and-punishment-dennis-kozlowski-tyco-internationals-big-spending-vulgarian","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1132017913","content_text":"Does crime pay?\nWall Street Crime and Punishment is a weekly series by Benzinga's Phil Hall chronicling the bankers, brokers and financial ne’er-do-wells whose ambition and greed take them in the wrong direction.\nIn Dennis Kozlowski’s mind, he was in the wrong place at the wrong time — specifically, the courts of justice and public opinion in the early 2000s, when the corporate chieftains of Worldcom, EnronandAdelphia,not to mention the ultra-high-profile Martha Stewart,faced humiliating trials and convictions followed by prison sentences.\nKozlowski, who was convicted on 22 counts of grand larceny, conspiracy and securities fraud and served more than six years in prison following a high-profile leadership reign as CEO of Tyco International,lamented that he would never have faced a legal nightmare if his case came up during the Obama Justice Department era when prosecutions of badly behaved corporate leaders barely occurred.\n“After 2008, nobody was prosecuted,” he grumbled.\nBut if Kozlowski’s fall from grace did not take place when the stars were aligned in his favor, he found an ally in time during his post-incarceration years, where access to friendly media outlets have helped to redefine the circumstances of his derailment and allow his reinvention as a self-described martyr to a dysfunctional justice system.\nThe Boom Years: Leo Dennis Kozlowski was born Nov. 16, 1946, in Newark, New Jersey. His father worked in Newark’s public transportation service and his mother did double-duty as a school crossing guard and Newark Police Department employee.\nKozlowski held a variety of odd jobs in his youth, including stints at a car wash and a pharmacy, to finance his education at New Jersey’s Seton Hall University.\nHe briefly worked at SCM Corporation in New York City and Cabot Corporation in Boston before joining the Nashua, New Hampshire, division of Tyco International in 1975 as an accountant with an annual salary of $28,000.\nHe worked his way up through the ranks, landing the chief operating officer title by 1989 and CEO spot in 1992. Kozlowski’s ascension was mirrored by Tyco’s blossoming from a somewhat sleepy little security systems company with $20 million in revenue into a global conglomerate with more than $40 billion in revenue and a market capitalization of more than $110 billion.\nTyco’s remarkable growth was based solely on the surplus number of acquisitions that Kozlowski was able to pull off during his chief executive years. A July 1998 profile of Kozlowski in Forbes marveled at how he orchestrated 88 different acquisitions during his first six years at the company’s helm, dubbing him “Deal-a-Month Dennis” for his ability to quickly secure takeovers.\nWhile the magazine ogled at the quantity of the acquisitions, Kozlowski highlighted the quality of the deals.\n\"We're fully aware that most acquisitions don't work,\" Kozlowski said. \"Taking a gamble on a future revenue stream is a neighborhood we don't need to play in.\"\nThe key to success in this area, he added, was assimilating the acquired company as quickly as possible to ensure a swift and seamless integration into the Tyco culture.\n\"Our obligation is to get the cost out and get that over with quickly so we can move on from there and get the growth going in the company,\" he said.\nIn retrospect, Kozlowski admitted his penchant for purchasing companies was sloppy around the edges.\n“I did push the organization hard and we built up a large company from nothing very quickly,” he said in a June 2020 interview with the Nantucket-based N Magazine. “We went from infancy to adulthood without passing through adolescence. And in that process, we never built the infrastructure or the documentation that most companies have to support the kind of growth we had.\n“We didn’t have the lawyers or financial people on staff to support the large businesses that we were running,” he continued. “I was guilty of not building a corporate staff that was comparable to the size of the organization we were running.”\nActually, there was a bit more to his story than inadequate human resources support.\nThe Very Ripe Fruits Of Success: While Kozlowski’s business acumen enriched Tyco, he did not believe that the CEO of a multi-billion-dollar conglomerate was meant to endure the life of an ascetic.\nKozlowski’s life beyond his office would take the notion of excessive consumption to vulgar depths, with an extravagance befitting of decadent royal houses of days gone by.\nKozlowski owned a $30 million duplex apartment on New York City’s swanky Fifth Avenue that included a $15,000 umbrella stand and a $6,000 shower curtain in his maid’s bathroom. Other property holdings included several acres in a Boca Raton, Florida, gated community known as “The Sanctuary” and a multi-million-dollar oceanfront mansion on Nantucket.\nHe was also a generous host when it came to entertaining family and friends, most notably for the 40th birthday of Karen Kozlowski, his second wife — he arranged for a party on the Italian island of Sardinia that included a private concert by Jimmy Buffett and an ice sculpture of Michelangelo’s David that featured Stolichnaya vodka pouring from the Goliath-slayer’s penis.\nKozlowski would later claim that expensive material goods only brought him a fleeting sense of self-worth.\n“What did happen is that I wanted to show my success,” he recalled in an interview. “So I acquired some homes, a boat and things that I had little time to use. I was probably on [my sailing yacht] Endeavour 10 nights a year. I was probably at my ski house in Bachelor Gulch [Colorado] maybe five or six nights a year over the holidays. So I don’t know the exact numbers, but I never used any of these assets when I acquired them.”\nOf course, being nouveau riche with extraordinary bad taste might be an aesthetic crime, but it is not a violation of state or federal law.\nKozlowski’s problem, however, involved who was footing the bill for the Marie Antoinette-worthy shower curtain and the decidedly non-Biblical David. The Sardinia party cost $2 million with Tyco covering half of the bill and his extensive real estate holdings were also traced to the Tyco coffers.\nIn 2002, Kozlowski sought to put Tyco’s money to classier use when he purchased a series of paintings that included a Claude Monet and Pierre-August Renoir for $14 million. The office of Robert Morgenthau, the New York County District Attorney, had been suspicious of the quickie nature of some of those aforementioned Tyco acquisitions, and a careful probe of Kozlowski’s art purchases showed that he evaded paying sales tax on those items. Even worse, they were invoiced for display at Tyco’s headquarters and not Kozlowski’s residence.\nMorgenthau, who never shied away from the prospect of a high-profile investigation that would put his name in the headlines, zeroed in on Tyco and Kozlowski.\nGetting What They Paid For? In his N Magazine interview, Kozlowski would recall that he was earning a $1 million annual salary at the time that his troubles began to ferment, but he insisted Tyco operated an independent compensation board that he did not control or influence. Kozlowski also stated that he was considering early retirement and announced his plans to the board of directors, only to have the compensation committee talk him into staying.\n“The compensation committee got together and came back and said, ‘We really want you to stay — we’ll give you three times your salary, stock and unlimited use of an airplane, an apartment and staff to take care of all this for the rest of your life,'” he said.\n“So I went to our vice president of HR, and said, ‘The board offer is probably worth over $100 million dollars. Please go back to the board and tell them I want three times my annual compensation of the stock, the bonus and the salary.’ I thought there was no way in hell that they would ever support that. To my surprise, they approved it.”\nBut that is not what Morgenthau’s office saw. Kozlowski retired from Tyco in June 2002 and two months later he was indicted on 23 counts of conspiracy, securities fraud, grand larceny and falsifying records. Tyco’s former chief financial officer Mark Swartz was also indicted at the same time on similar charges. The indictments were unusual because the defendants were being charged in a state court rather than a federal court — the U.S. Department of Justice never became involved in Kozlowski’s case.\n“Morgenthau was running for re-election and he was facing his first real challenge at the time,” Kozlowski later stated. “He had been district attorney for many years. He wanted to show that he was going to prosecute white-collar crime as well as the day-to-day crimes of New York.”\nWhen Kozlowski came to trial in 2003, the prosecutors charged him with using Tyco as a personal piggy bank — he was accused of pocketing $81 million in unauthorized bonuses. Kozlowski’s attorneys argued that all of the money that went from Tyco to their client was authorized and he never looted the company.\nIf it was simply a he-said/he-said case, Kozlowski’s attorneys might have been able to dismantle the prosecutor’s volleys. But Morgenthau and his team had a damaging weapon: scores of videos that detailed Kozlowski’s reckless extravagance. One video showed the Sardinian party with its wacky excesses, while another offered Kozlowski’s former maid giving a tour of his Fifth Avenue apartment — she claimed he never lived there and only stopped by very occasionally, usually for a change of clothing.\nKozlowski’s trial was heading to a conviction when a mistrial was declared after one juror — who was supposedly holding out for acquittal — received threatening messages about her refusal to convict. A second trial was held and Kozlowski was found guilty on 22 of the 23 charges against him. He was acquitted of one count of falsifying records. He was also ordered to pay $100 million in restitution.\nPrior to his September 2005 sentencing, Kozlowski claimed he was convicted of bad optics.\n“I was a guy sitting in a courtroom making $100 million a year and I think a juror sitting there just would have to say, 'All that money? He must have done something wrong,'” he said. “I think it's as simple as that.”\nRedemption Song: Kozlowski served a six-and-a-half-year prison sentence, and it was only during his second parole hearing — the first effort ended in failure — did he show any degree of remorse, claiming his actions were the result of “greed, pure and simple — I feel horrible. I can't say how sorry I am and how deeply I regret my actions.”\nIn prison, Kozlowski was initially placed in solitary confinement for six months out of initial fear that he would be targeted by prison gangs due to his wealth, but he later ingratiated himself with fellow inmates by tutoring those in pursuit of their GED. He also began to reshape his public image by agreeing to interviews with the Wall Street Journal and CBS' “60 Minutes” where he presented himself as a reforming work-in-progress.\nSince his release in 2014, Kozlowski has turned up in multiple media interviews and guest speaking engagements detailing his rise, fall and return to everyday life; the remorse from his successful parole hearing never resurfaced.\nKozlowski relocated to Fort Lauderdale, Florida, and co-founded the merger-and-acquisitions consultancy Harborside Advisors with his third wife, Kimberly Fusaro-Kozlowski, who first contacted him while he was still in prison; his second wife Karen, the object of the Sardinia party, divorced him in 2006 while he was appealing his conviction.\nHe also co-founded Commandscape, a security and building management company, with Netscape founder Jim Clark as his business partner. He also chaired The Fortune Society in New York, a nonprofit that assists former inmates in their return to society.\nKozlowski’s case has been addressed by prominent lawyers who questioned whether justice was truly served. Catherine S. Neal wrote the impassioned “Dennis Kozlowski Was Not a Thief” for the January 2014 Harvard Business Review and expanded her thesis into the book “Taking Down the Lion: The Triumphant Rise and Tragic Fall of Tyco’s Dennis Kozlowski.”\nAnd noted civil rights attorney Dan Ackman stated that while Kozlowski and co-defendant Swartz “acted like pigs,” the larceny charges brought against them “did not depend on whether the defendants took the money — they did — but whether they were authorized to take it. Questions of authority are, by nature, legal questions, not questions for jurors.”\nUltimately, Kozlowski sought to have the last word on his case, insisting in an April 2021 interview with Leaders Magazine that he came out of these experiences a better man.\n“It was a real lesson in friendship and there were surprises along the way,” he said. “People became true friends who I had not really known were true friends, and people that I expected to be there for me were long gone. You really don’t find out who your true friends are and who you can count on until you really need them.”","news_type":1,"symbols_score_info":{}},"isVote":1,"tweetType":1,"viewCount":1627,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"defaultTab":"posts","isTTM":false}