Aquestive 完成 FDA A 型會議，討論 Anaphylm NDA 重新提交事宜

該公司已完成與 FDA 的面對面 A 型會議，並收到關於 Anaphylm（dibutepinephrine）舌下膜 NDA 重新提交的初步意見。此次會議為治療第 1 型過敏反應（包括過敏性休克）的 NDA 重新提交提供了監管回饋。

關鍵事實

申報時間: 2026年3月30日上午11:44
事件: 其他
方向: 中性
公司: AQSTAquestive
資產: epinephrine
來源: SEC 8-K
可信度: 有出處

來源摘錄

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