DBV Technologies：计划于2026年上半年提交VIASKIN花生贴片（4-7岁）的BLA

8-K文件显示，VITESSE III期试验的顶线结果呈阳性，公司现预计将于2026年上半年提交针对4-7岁花生过敏儿童的VIASKIN花生贴片BLA，并有可能获得优先审评资格。针对1-3岁幼儿的第二份BLA提交计划于2026年下半年通过加速批准途径提交。这些计划中的申报是该产品下一阶段的具体监管里程碑。

关键事实

申报时间: 2026年3月26日 21:25
事件: 申请已提交
方向: 积极
公司: DBVTDBV Technologies
资产: VIASKIN Peanut Patch
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 d113165dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DBV Technologies Reports Full Year 2025 Financial Results and Business Update • Continued advancing the VIASKIN ® Peanut Patch clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old) • Bolstered executive leadership team in preparation for BLA submission and potential approval • Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “ Company ”), a late-stage biopharmaceutical company, today reported financial results for the full

SEC 8-K