Aquestive Plans Q3 AnaphylM NDA Resubmission After Receiving FDA CRL
Aquestive Therapeutics presented its AnaphylM anaphylaxis therapy at the Oppenheimer conference, emphasizing potential advantages over existing emergency allergy treatments. The company plans to resubmit the AnaphylM NDA in Q3 after receiving an FDA Complete Response Letter.
1. Company Presents AnaphylM at Oppenheimer Conference
Aquestive detailed its AnaphylM candidate for anaphylaxis treatment, highlighting its potential benefits over injectable epinephrine and its opportunity to capture emergency allergy care market share.
2. Details of FDA Complete Response Letter
The FDA issued a Complete Response Letter following the initial NDA review, requesting additional chemistry, manufacturing and controls data and clarification on key clinical endpoints.
3. Strategy for Q3 Resubmission
Aquestive plans to integrate detailed CMC enhancements and updated efficacy analyses into its revised NDA, targeting a Q3 submission to align with its development milestones and regain FDA review momentum.