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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>

After reviewing the FDA's information requests and considering all other options, DBV Technologies h

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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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 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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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