secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2026-09-17T11:02:30+00:00
Accession:  0001398733-26-000044
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive resubmits Anaphylm NDA to FDA; addresses CRL with positive human factor/PK data
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- Resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film to FDA on Sept 17, 2026, for Type I allergic reactions including anaphylaxis.
- Human factors study with revised packaging cut median pouch-opening time from 17s to 3s; no protocol-defined use errors in self-administration arm of confirmatory PK study.
- Original NDA filed March 2025; FDA CRL issued Jan 30, 2026, requested human factors and confirmatory PK studies.
- FDA will determine resubmission classification and set review timeline after initial review of the resubmission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/0001398733-26-000044-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/aqst-20260914.htm
  HTML page:      https://secwatch.observer/filing/0001398733-26-000044

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