---
schema_version: "secwatch.filing_event.v1"
accession: "0001398733-26-000003"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2026-01-09T23:59:59+00:00"
generated_at: "2026-05-16T11:02:37.087479+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA identifies deficiencies in Aquestive's Anaphylm NDA, precluding labeling talks

## Summary
- FDA letter notes deficiencies in Anaphylm NDA that preclude labeling and post-marketing discussions; review ongoing with PDUFA date Jan 31, 2026.
- Company working to understand and resolve deficiencies; delay in potential approval possible if concerns not resolved by PDUFA date.
- Unaudited cash and equivalents of ~$120M as of Dec 31, 2025; company believes it is sufficient for U.S. launch and global expansion.
- Global strategy advancing: expects to submit in Canada H1 2026, Europe H2 2026, and feedback from UK MHRA in Q1 2026.
- Anaphylm supported by 11 clinical studies with ~967 administrations; PK profile comparable to epinephrine auto-injectors.

## SEC filing metadata
- accession: 0001398733-26-000003
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2026-01-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000003/0001398733-26-000003-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000003/aqst-20260109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001398733-26-000003
- JSON: https://secwatch.observer/filing/0001398733-26-000003.json
- Plain text: https://secwatch.observer/filing/0001398733-26-000003.txt

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