原始出處紀錄
重大申請已送件
DBV Technologies 將 VIASKIN 花生貼片 BLA 延後至 2026 年第三季
DBV 現將其 VIASKIN 花生貼片用於 4-7 歲兒童的 BLA 提交時間調整至 2026 年第三季，而非先前時程。此延遲係因與 FDA 進行廣泛的提交前對話，以優化 CMC 及生物統計資料的整理。FDA 並未要求任何額外臨床資料。
關鍵事實
- 申報時間
- 2026年6月29日 下午08:28
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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