---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-043505"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2024-10-24T23:59:59+00:00"
generated_at: "2026-05-30T10:24:35.048639+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Aquestive positive OAS study: Anaphylm resolves symptoms in 12 min median, meets endpoints

## Summary
- OAS challenge study met primary and secondary endpoints; no significant PK difference with vs. without allergen.
- Median time to complete symptom resolution: 12 minutes (vs. 74 minutes at screening); symptoms began resolving as early as 2 min.
- All instances of symptomatic swelling resolved within 5 minutes after Anaphylm administration.
- Pre-NDA meeting with FDA requested in Q4 2024; NDA submission planned Q1 2025; potential launch Q1 2026 if approved.
- Anaphylm is a non-invasive oral epinephrine film for severe allergic reactions; adverse events mild/moderate and resolved.

## SEC filing metadata
- accession: 0001628280-24-043505
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2024-10-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/0001628280-24-043505-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/aqst-20241024.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-043505
- JSON: https://secwatch.observer/filing/0001628280-24-043505.json
- Plain text: https://secwatch.observer/filing/0001628280-24-043505.txt

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