---
schema_version: "secwatch.filing_event.v1"
accession: "0001398733-26-000044"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2026-09-17T11:02:30+00:00"
generated_at: "2026-09-17T11:05:07.466642+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Aquestive resubmits Anaphylm NDA to FDA; addresses CRL with positive human factor/PK data

## Summary
- 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.

## SEC filing metadata
- accession: 0001398733-26-000044
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2026-09-17T11:02:30+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/0001398733-26-000044-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/aqst-20260914.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001398733-26-000044
- JSON: https://secwatch.observer/filing/0001398733-26-000044.json
- Plain text: https://secwatch.observer/filing/0001398733-26-000044.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.