---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-015759"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2025-04-01T23:59:59+00:00"
generated_at: "2026-05-24T00:34:51.122106+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Aquestive reports positive pediatric PK results for Anaphylm; NDA submitted to FDA

## Summary
- Pediatric study (32 patients aged 7-17, >30 kg) shows PK consistent with adult studies; no serious adverse events.
- Anaphylm NDA submitted to FDA; acceptance decision expected in Q2 2025.
- Company targets Q1 2026 launch if FDA approves Anaphylm.
- Positive pediatric data could enable a label covering patients aged 7 and older.

## SEC filing metadata
- accession: 0001628280-25-015759
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2025-04-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828025015759/0001628280-25-015759-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828025015759/aqst-20250401.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-015759
- JSON: https://secwatch.observer/filing/0001628280-25-015759.json
- Plain text: https://secwatch.observer/filing/0001628280-25-015759.txt

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