secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2026-10-15T11:21:16+00:00
Accession:  0001398733-26-000058
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/0001398733-26-000058-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/aqst-20261015.htm
  HTML page:      https://secwatch.observer/filing/0001398733-26-000058

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer