---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-041432"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2024-09-27T23:59:59+00:00"
generated_at: "2026-05-31T01:06:19.230524+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Aquestive completes Anaphylm oral allergen challenge enrollment; unveils AQST-108 Phase 2 for alopecia areata

## Summary
- Anaphylm (epinephrine sublingual film) oral allergen challenge study fully enrolled; topline data expected Q4 2024.
- Pre-NDA meeting request submitted to FDA; NDA submission planned for Q1 2025, launch by end-2025 or early 2026.
- AQST-108 (epinephrine topical gel) first human study completed: no serious adverse events, zero plasma drug levels observed.
- AQST-108 to be developed for alopecia areata (6.7M US patients); Phase 2 design outlined for mild-to-moderate disease.
- Pre-IND meeting for AQST-108 targeted Q1 2025; Phase 2 initiation expected H2 2025 pending FDA alignment.

## SEC filing metadata
- accession: 0001628280-24-041432
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2024-09-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828024041432/0001628280-24-041432-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828024041432/aqst-20240927.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-041432
- JSON: https://secwatch.observer/filing/0001628280-24-041432.json
- Plain text: https://secwatch.observer/filing/0001628280-24-041432.txt

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