regulatory
confidence high
sentiment positive
materiality 0.80
Aquestive receives positive FDA feedback for Anaphylm; reaffirms Q1 2025 NDA submission
Aquestive Therapeutics, Inc.
- FDA agreed on NDA content, safety evaluation, and pediatric trial plan; no additional adult trials needed.
- Single-dose pediatric trial commenced in U.S. and Canada in December 2024.
- FDA noted an advisory committee meeting may be necessary due to new route of administration.
- Reaffirms NDA submission guidance for Q1 2025.