Aquestive Therapeutics, Inc. (AQST) — Current Report

AI-Powered SEC Filing Analysis

Latest Current Report Filed: 2026-03-30

Key Insights

Aquestive Therapeutics received preliminary comments and successfully completed a Type A meeting with the FDA regarding the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis.
The successful completion of the FDA meeting indicates progress in the regulatory approval process for Anaphylm, a potential treatment for a serious medical condition.
Investors should monitor further updates on the NDA resubmission and the FDA's review process, as the approval of Anaphylm could be a significant milestone for the company.

Want the newest filings?

This analysis covers the filing from 2026-03-30. New 10-K, 10-Q and 8-K filings are analyzed the moment they are released — exclusively in the app.

Download on the App Store Open in app →

Earlier Current Report filings

Filed: 2026-03-20

Aquestive Therapeutics has announced the departure of its Chief Legal Officer and Chief Compliance Officer, Lori J. Braender, effective April 2, 2026. The company has appointed Thomas A. Zalewski as the new Chief Legal Officer and Chief Compliance Officer.
Braender will remain with the company in a transition role until May 7, 2026, and will continue to serve as the Corporate Secretary through at least year-end. She will be entitled to severance benefits, including a pro-rata bonus, salary continuation, and full vesting of her equity awards.
The leadership change and transition terms outlined in the 8-K filing suggest that the departure of the Chief Legal Officer and Chief Compliance Officer is a planned and amicable event, which may provide stability and continuity for the company's legal and compliance functions.

Filed: 2026-02-26

Aquestive Therapeutics, Inc. is furnishing an investor presentation, which provides an update on the company's business and financial performance.
The presentation is being shared with institutional investors, analysts, and others, indicating the company is actively engaging with the investment community.
The availability of the presentation on the company's website suggests transparency and a desire to share information with shareholders and potential investors.

Filed: 2026-01-09

The FDA has identified deficiencies in Aquestive Therapeutics' New Drug Application (NDA) for its product candidate Anaphylm, which could result in a delay in potential FDA approval.
The company is working to understand and resolve the FDA's concerns prior to the scheduled PDUFA goal date of January 31, 2026.
Aquestive Therapeutics is continuing to advance its global strategy for Anaphylm, with plans to seek regulatory approval in Canada and Europe in 2026.

Other reports for Aquestive Therapeutics, Inc.

Insider Trading

Important Information

AI-generated analysis is for informational purposes only. Always read original SEC filings and consult with qualified professionals before making investment decisions.