secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2024-08-14T23:59:59+00:00
Accession:  0001628280-24-037053
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive reiterates Q1 2025 NDA filing for Anaphylm; notes FDA approval of non-injection epinephrine
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- CEO Daniel Barber applauds FDA approval of first non-injection-based epinephrine device for anaphylaxis.
- Reiterates NDA submission for Anaphylm (epinephrine) Sublingual Film in Q1 2025.
- Oral allergy syndrome (OAS) challenge study completion expected late Q3 or early Q4 2024.
- Full product launch of Anaphylm, if approved, targeted for end of 2025 or Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024037053/0001628280-24-037053-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024037053/aqst-20240814.htm
  HTML page:      https://secwatch.observer/filing/0001628280-24-037053

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