regulatory
confidence high
sentiment positive
materiality 0.55
Aquestive completes FDA Type A meeting for Anaphylm; NDA resubmission reaffirmed for Q3 2026
Aquestive Therapeutics, Inc.
- Received FDA clarifying feedback on PK and human factor study designs for Anaphylm.
- FDA aligned on labeling to manage potential chewing of film, avoiding additional clinical data.
- Container closure changes acknowledged; will be tested in upcoming HF study.
- Final FDA meeting minutes expected by early May 2026.
- Regulatory submissions for Canada and EU continue.