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2021-12-21

DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low<blockquote>DBV Technologies将对花生过敏贴剂进行新的关键试验，股价暴跌至52周低点</blockquote>

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uptake/transport study before STAMP).</p><p><blockquote>在审查了FDA的信息请求并考虑了所有其他选项后，<b>DBV技术</b>已决定不采用序贯方法开发Viaskin Peanut（STAMP之前的过敏原摄取/转运研究）。</blockquote></p><p> <ul>  <li>DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.</li>  <li>Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.</li>  <li>The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.</li>  <li>The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.</li>  <li>DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.</li>  <li>At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).</li>  <li><b>Price Action:</b>&nbsp;DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.</li> </ul></p><p><blockquote><ul><li>DBV估计，在启动STAMP（一项为期6个月的安全性和粘附性研究）之前，遵守FDA新提出的顺序方法将需要至少五轮需要FDA协调的交流。</li><li>相反，DBV将在目标患者人群中启动一项针对儿童改良Viaskin花生贴片的3期研究。</li><li>该研究将采用改良的Viaskin Peanut（mVP）贴片，该贴片呈圆形，比当前的Viaskin Peanut（cVP）贴片大约50%。</li><li>该公司正在最终确定该方案，并预计在2022年2月底之前向FDA提交该方案。</li><li>DBV Technologies也决定撤回欧洲营销申请Viaskin Peanut。</li><li>在撤回时，它正在接受EMA人用药品委员会(CHMP)的审查。</li><li><b>价格走势：</b>周二最后一次盘前交易中，DBVT股价下跌25.90%，至2美元。</li></ul></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>DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low<blockquote>DBV Technologies将对花生过敏贴剂进行新的关键试验，股价暴跌至52周低点</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; 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style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga </p>\n<p class=\"h-time smaller\">2021-12-21 22:22</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<p>After reviewing the FDA's information requests and considering all other options,&nbsp;<b>DBV Technologies</b>&nbsp;has&nbsp;decided not to pursue the sequential approach&nbsp;to develop Viaskin Peanut (allergen uptake/transport study before STAMP).</p><p><blockquote>在审查了FDA的信息请求并考虑了所有其他选项后，<b>DBV技术</b>已决定不采用序贯方法开发Viaskin Peanut（STAMP之前的过敏原摄取/转运研究）。</blockquote></p><p> <ul>  <li>DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.</li>  <li>Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.</li>  <li>The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.</li>  <li>The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.</li>  <li>DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.</li>  <li>At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).</li>  <li><b>Price Action:</b>&nbsp;DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.</li> </ul></p><p><blockquote><ul><li>DBV估计，在启动STAMP（一项为期6个月的安全性和粘附性研究）之前，遵守FDA新提出的顺序方法将需要至少五轮需要FDA协调的交流。</li><li>相反，DBV将在目标患者人群中启动一项针对儿童改良Viaskin花生贴片的3期研究。</li><li>该研究将采用改良的Viaskin Peanut（mVP）贴片，该贴片呈圆形，比当前的Viaskin Peanut（cVP）贴片大约50%。</li><li>该公司正在最终确定该方案，并预计在2022年2月底之前向FDA提交该方案。</li><li>DBV Technologies也决定撤回欧洲营销申请Viaskin Peanut。</li><li>在撤回时，它正在接受EMA人用药品委员会(CHMP)的审查。</li><li><b>价格走势：</b>周二最后一次盘前交易中，DBVT股价下跌25.90%，至2美元。</li></ul></blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"DBVT":"DBV Technologies S.A."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1120012619","content_text":"After reviewing the FDA's information requests and considering all other options, DBV Technologies has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).\n\nDBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.\nInstead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.\nThe study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.\nThe Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.\nDBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.\nAt the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).\nPrice Action: DBVT shares are down 25.90% at $2 during the premarket session on the last check 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