secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2024-10-24T23:59:59+00:00
Accession:  0001628280-24-043505
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive positive OAS study: Anaphylm resolves symptoms in 12 min median, meets endpoints
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- OAS challenge study met primary and secondary endpoints; no significant PK difference with vs. without allergen.
- Median time to complete symptom resolution: 12 minutes (vs. 74 minutes at screening); symptoms began resolving as early as 2 min.
- All instances of symptomatic swelling resolved within 5 minutes after Anaphylm administration.
- Pre-NDA meeting with FDA requested in Q4 2024; NDA submission planned Q1 2025; potential launch Q1 2026 if approved.
- Anaphylm is a non-invasive oral epinephrine film for severe allergic reactions; adverse events mild/moderate and resolved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/0001628280-24-043505-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/aqst-20241024.htm
  HTML page:      https://secwatch.observer/filing/0001628280-24-043505

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