原始出處紀錄
重大申請已送件
DBV Technologies 計畫於 2026 年上半年提交 VIASKIN 花生貼片 BLA 申請
新聞稿確認該公司正按計畫於 2026 年上半年提交 4-7 歲兒童 VIASKIN 花生貼片 BLA 申請，此前已與 FDA 就安全性資料要求達成共識，並取得正面第三期試驗結果。經 PIPE 融資後，現金可支應至 2027 年第二季，支持商業化準備工作。另指引 1-3 歲幼兒之 BLA 申請將於 2026 年下半年提交。
關鍵事實
- 申報時間
- 2026年4月30日 下午09:30
- 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 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