---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-049497"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2024-12-02T23:59:59+00:00"
generated_at: "2026-05-29T11:04:39.939632+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Aquestive receives positive FDA feedback for Anaphylm; reaffirms Q1 2025 NDA submission

## Summary
- FDA agreed on NDA content, safety evaluation, and pediatric trial plan; no additional adult trials needed.
- Single-dose pediatric trial commenced in U.S. and Canada in December 2024.
- FDA noted an advisory committee meeting may be necessary due to new route of administration.
- Reaffirms NDA submission guidance for Q1 2025.

## SEC filing metadata
- accession: 0001628280-24-049497
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2024-12-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828024049497/0001628280-24-049497-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828024049497/aqst-20241202.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-049497
- JSON: https://secwatch.observer/filing/0001628280-24-049497.json
- Plain text: https://secwatch.observer/filing/0001628280-24-049497.txt

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