secwatch.observer — SEC 8-K summary
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Issuer:     Aquestive Therapeutics, Inc. (AQST)
CIK:        0001398733
Form:       8-K
Filed at:   2024-04-29T23:59:59+00:00
Accession:  0001628280-24-018802
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves Libervant for seizure clusters in children 2-5; Anaphylm NDA on track for end of 2024
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- Libervant is first FDA-approved oral rescue treatment for seizure clusters in patients ages 2-5.
- Immediate availability of 5mg, 7.5mg, 10mg, 12.5mg, and 15mg; non-Medicaid prescriptions being filled.
- Over 55,000 prescriptions filled in 2023 for this age group, 90% for diazepam rectal gel.
- Anaphylm clinical program on track; NDA submission planned by end of 2024.
- This is the Company's 4th FDA approval since 2018.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024018802/0001628280-24-018802-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1398733/000162828024018802/aqst-20240426.htm
  HTML page:      https://secwatch.observer/filing/0001628280-24-018802

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