原始来源记录
重大申请已提交
DBV Technologies 将 VIASKIN 花生贴片 BLA 推迟至 2026 年第三季度
DBV 现在将为 4-7 岁儿童提交 VIASKIN 花生贴片的 BLA，时间定在 2026 年第三季度，而非原先的时间表。此次延误是在与 FDA 进行了广泛的提交前对话，以优化 CMC 和生物统计数据组织之后发生的。FDA 并未要求提供任何额外的临床数据。
关键事实
- 申报时间
- 2026年6月29日 20:28
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 d108693dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Châtillon, France, June 29, 2026 DBV Technologies Provides BLA Submission Update for the VIASKIN ® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing • DBV has been engaged in extensive discussions with the FDA in preparation of its BLA for the VIASKIN ® Peanut Patch in children aged four through seven years • The objective of the detailed, iterative engagement was to ensure a complete, efficient, and timely FDA review of the BLA, once submitted • The Agency has not requested additional data • DBV will take additional time to incorporate the FDA feedback and anticipates submitting the BLA in the third quarter of 2026 • DBV will host a co