---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-031455"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2025-06-16T23:59:59+00:00"
generated_at: "2026-05-19T06:12:05.375145+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Aquestive's NDA for Anaphylm; PDUFA date Jan 31, 2026

## Summary
- FDA accepted NDA for Anaphylm (epinephrine oral film) to treat Type 1 allergic reactions, including anaphylaxis.
- PDUFA target action date assigned as January 31, 2026; FDA may hold an Advisory Committee meeting.
- If approved, Anaphylm would be first and only orally delivered epinephrine option in the U.S.
- Product is a thin, device-free film that requires no special storage, fitting in wallet or pocket.

## SEC filing metadata
- accession: 0001628280-25-031455
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2025-06-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/0001628280-25-031455-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/aqst-20250613.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-031455
- JSON: https://secwatch.observer/filing/0001628280-25-031455.json
- Plain text: https://secwatch.observer/filing/0001628280-25-031455.txt

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