---
schema_version: "secwatch.filing_event.v1"
accession: "0001398733-26-000005"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2026-02-02T23:59:59+00:00"
generated_at: "2026-05-16T05:34:55.116759+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Aquestive receives FDA CRL for Anaphylm; deficiencies limited to packaging, administration

## Summary
- FDA CRL Jan 30, 2026 for Anaphylm NDA; deficiencies in human factors validation study and request for PK study.
- Company plans Type A meeting, new HF and PK studies; expects resubmission in Q3 2026.
- Global: positive EMA feedback no further trials needed; submit in Europe and Canada H2 2026; UK feedback Q1 2026.
- CEO: issues limited to packaging/administration; company well-capitalized to complete approval and pre-launch.

## SEC filing metadata
- accession: 0001398733-26-000005
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2026-02-02T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/0001398733-26-000005-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/aqst-20260130.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001398733-26-000005
- JSON: https://secwatch.observer/filing/0001398733-26-000005.json
- Plain text: https://secwatch.observer/filing/0001398733-26-000005.txt

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