regulatory
confidence high
sentiment positive
materiality 0.90
Aquestive reports positive pediatric PK results for Anaphylm; NDA submitted to FDA
Aquestive Therapeutics, Inc.
- Pediatric study (32 patients aged 7-17, >30 kg) shows PK consistent with adult studies; no serious adverse events.
- Anaphylm NDA submitted to FDA; acceptance decision expected in Q2 2025.
- Company targets Q1 2026 launch if FDA approves Anaphylm.
- Positive pediatric data could enable a label covering patients aged 7 and older.