secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2026-08-10T11:05:44+00:00
Accession:  0001398733-26-000035
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive reports positive Anaphylm human factors and PK study results; NDA resubmission on track for Q3 2026
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- Median pouch-open time cut from 17s to 3s; incorrect film placement down >80% in revised HF study.
- PK study: self-admin Cmax 391.7 pg/mL vs clinician 357.6 and IM 334.5; Tmax 12 min vs 45 min for IM.
- Top-of-tongue placement still gave Cmax >100 pg/mL and PD comparable to injectable epinephrine.
- No serious adverse events or discontinuations in PK study; no administration errors in self-administration arm.
- NDA resubmission on track for Q3 2026; also advancing filings in Canada, UK, EU.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000035/0001398733-26-000035-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000035/aqst-20260810.htm
  HTML page:      https://secwatch.observer/filing/0001398733-26-000035

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