Aquestive 完成 FDA A 类会议，推进 Anaphylm NDA 重新提交

该公司已完成与 FDA 的面对面 A 类会议，并收到关于 Anaphylm（dibutepinephrine）舌下膜 NDA 重新提交的初步意见。此次会议为 1 型过敏反应（包括过敏性休克）治疗药物 NDA 的重新提交提供了监管反馈。

关键事实

申报时间: 2026年3月30日 11:44
事件: 其他
方向: 中性
公司: AQSTAquestive
资产: epinephrine
来源: SEC 8-K
可信度: 有来源

来源摘录

aqst-20260330 0001398733 false 0001398733 2026-03-30 2026-03-30 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): March 30, 2026 Aquestive Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 001-38599 82-3827296 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 30 Technology Drive Warren , NJ 07059 ( 908 ) 941-1900 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) Not Applicable (Former name or former address, if changed since last report) _______________________

SEC 8-K