Aquestive Therapeutics announced the successful completion of a Type A meeting with the FDA regarding the resubmission of its Anaphylm NDA, reaffirming its guidance to resubmit in Q3 2026.
Key takeaways
Aquestive Therapeutics successfully completed an in-person Type A meeting with the FDA on March 30, 2026, regarding the resubmission of the Anaphylm NDA.
The company reaffirmed its guidance to resubmit the Anaphylm New Drug Application in the third quarter of 2026.
The FDA provided preliminary comments on the pharmacokinetic study design, focusing on consistency with past studies.
The FDA provided preliminary comments on the human factors validation study design, recommending changes to user groups.
The company shared revisions to the product container closure opening mechanisms with the FDA, which will be tested in the upcoming human factors study.
Final FDA meeting minutes from the Type A meeting are expected by early May 2026.