secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2025-09-04T23:59:59+00:00
Accession:  0001398733-25-000016
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA will not require advisory committee for Aquestive's Anaphylm NDA; PDUFA Jan 31, 2026
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- FDA informed Aquestive that no advisory committee meeting is required for Anaphylm (dibutepinephrine) Sublingual Film NDA.
- PDUFA target action date remains January 31, 2026; commercial planning underway for rapid post-approval launch.
- Anaphylm could be first FDA-approved, non-invasive, orally delivered epinephrine for severe allergic reactions, including anaphylaxis.
- Company recently completed $160M in financing activities to support broad healthcare provider and patient outreach upon approval.
- NDA includes 11 clinical studies with 967 administrations (single and repeat dose) in adults and children over 30 kg.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873325000016/0001398733-25-000016-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873325000016/aqst-20250904.htm
  HTML page:      https://secwatch.observer/filing/0001398733-25-000016

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