DBV Technologies计划于2026年上半年提交VIASKIN花生贴片的BLA申请

该新闻稿确认公司计划在2026年上半年提交针对4-7岁儿童的VIASKIN Peanut Patch BLA申请，此前已与FDA就安全性数据要求达成一致，并取得积极的3期试验结果。PIPE融资后现金储备可维持至2027年第二季度，支持商业化准备工作。另有针对1-3岁幼儿的BLA申请计划于2026年下半年提交。

关键事实

申报时间: 2026年4月30日 21:30
事件: 申请已提交
方向: 中性
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 d132063dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Press Release Châtillon, France, April 30, 2026 DBV Technologies Reports First Quarter 2026 Financial Results • Reported cash and cash equivalents of $229 million as of March 31, 2026 —providing funding into the second quarter of 2027 following the full exercise of the ABSA Warrants and BS Warrants issued in its March 2025 private placement (“PIPE”) financing • Continued disciplined execution focused on BLA filing in the first half of this year and commercial preparedness for the U.S. launch of the VIASKIN ® Peanut Patch for children aged 4 to 7 years, if approved DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financ

SEC 8-K