secwatch.observer — SEC 8-K summary
======================================

Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2026-03-30T23:59:59+00:00
Accession:  0001398733-26-000022
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive completes FDA Type A meeting for Anaphylm; NDA resubmission reaffirmed for Q3 2026
--------------------------------------------------------------------------------

- Received FDA clarifying feedback on PK and human factor study designs for Anaphylm.
- FDA aligned on labeling to manage potential chewing of film, avoiding additional clinical data.
- Container closure changes acknowledged; will be tested in upcoming HF study.
- Final FDA meeting minutes expected by early May 2026.
- Regulatory submissions for Canada and EU continue.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000022/0001398733-26-000022-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000022/aqst-20260330.htm
  HTML page:      https://secwatch.observer/filing/0001398733-26-000022

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer