---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-034890"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2025-07-15T23:59:59+00:00"
generated_at: "2026-05-18T06:27:40.876087+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Aquestive obtains Health Canada meeting for Anaphylm NDS; EMA briefing book submitted

## Summary
- Health Canada grants Q3 2025 meeting for planned New Drug Submission of Anaphylm (epinephrine) Sublingual Film.
- Initial briefing book submitted to European Medicines Agency; MA submission planned as soon as possible.
- U.S. NDA accepted with PDUFA target action date of January 31, 2026.
- Company pursuing parallel ex-U.S. regulatory pathways for needle-free, device-free anaphylaxis treatment.

## SEC filing metadata
- accession: 0001628280-25-034890
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2025-07-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828025034890/0001628280-25-034890-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828025034890/aqst-20250715.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-034890
- JSON: https://secwatch.observer/filing/0001628280-25-034890.json
- Plain text: https://secwatch.observer/filing/0001628280-25-034890.txt

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