secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2026-02-02T23:59:59+00:00
Accession:  0001398733-26-000005
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aquestive receives FDA CRL for Anaphylm; deficiencies limited to packaging, administration
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- FDA CRL Jan 30, 2026 for Anaphylm NDA; deficiencies in human factors validation study and request for PK study.
- Company plans Type A meeting, new HF and PK studies; expects resubmission in Q3 2026.
- Global: positive EMA feedback no further trials needed; submit in Europe and Canada H2 2026; UK feedback Q1 2026.
- CEO: issues limited to packaging/administration; company well-capitalized to complete approval and pre-launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/0001398733-26-000005-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/aqst-20260130.htm
  HTML page:      https://secwatch.observer/filing/0001398733-26-000005

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