---
schema_version: "secwatch.filing_event.v1"
accession: "0001398733-26-000022"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2026-03-30T23:59:59+00:00"
generated_at: "2026-05-15T08:21:17.884252+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001398733-26-000022
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2026-03-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000022/0001398733-26-000022-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000022/aqst-20260330.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001398733-26-000022
- JSON: https://secwatch.observer/filing/0001398733-26-000022.json
- Plain text: https://secwatch.observer/filing/0001398733-26-000022.txt

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