---
schema_version: "secwatch.filing_event.v1"
accession: "0001398733-26-000058"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2026-10-15T11:21:16+00:00"
generated_at: "2026-10-15T11:25:04.975135+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Aquestive's Anaphylm NDA resubmission; PDUFA goal date set for March 16, 2027

## Summary
- FDA acknowledged the Anaphylm NDA resubmission as complete and classified it as a Class 2 response, setting a PDUFA goal action date of March 16, 2027.
- Aquestive resubmitted September 16, 2026 after August 2026 positive topline human factors and PK study data addressed FDA's January 30, 2026 Complete Response Letter.
- Anaphylm (dibutepinephrine) sublingual film targets Type I allergic reactions including anaphylaxis; if approved it would be the first oral rescue medication for severe allergic reactions.
- Ex-U.S. strategy on track: New Drug Submission to Health Canada planned for Q4 2026.
- CEO Daniel Barber said the acceptance gives 'a clear path forward' and that commercial launch preparations are advancing.

## SEC filing metadata
- accession: 0001398733-26-000058
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2026-10-15T11:21:16+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/0001398733-26-000058-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/aqst-20261015.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001398733-26-000058
- JSON: https://secwatch.observer/filing/0001398733-26-000058.json
- Plain text: https://secwatch.observer/filing/0001398733-26-000058.txt

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