secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2025-06-16T23:59:59+00:00
Accession:  0001628280-25-031455
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/0001628280-25-031455-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/aqst-20250613.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-031455

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