原始出處紀錄
重大申請已送件
DBV Technologies：VIASKIN 花生貼片（4-7 歲）BLA 提交計畫於 2026 年上半年
8-K 指出，Phase 3 VITESSE 頂線結果為正面，公司現預計於 2026 年上半年提交 VIASKIN 花生貼片用於 4-7 歲花生過敏兒童的 BLA，並可能獲得優先審查資格。另指引於 2026 年下半年提交 1-3 歲幼兒的第二份 BLA，採用加速核准途徑。這些計畫中的申請代表該產品下一個具體的法規里程碑。
關鍵事實
- 申報時間
- 2026年3月26日 下午09:25
- 事件
- 申請已送件
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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