FDA accepts Aquestive Anaphylm application for review
- Aquestive Therapeutics received FDA acceptance for its Anaphylm resubmission with a March 16, 2027 goal action date.
- The regulatory clearance advances the company's product pipeline, with the stock trading unchanged at $4.63.
- The company stated the filing incorporates key study data to support upcoming commercial preparations and international expansion.
Aquestive Therapeutics (NASDAQ:AQST) received FDA acceptance for its Anaphylm resubmission with a March 16, 2027 action date.
The regulatory agency classified the resubmission as a Class 2 response following the company's September 16, 2026 filing.
The updated submission included positive human factors data to address a Complete Response Letter issued in January 2026.
Anaphylm is an oral sublingual film designed to deliver dibutepinephrine to treat Type I allergic reactions including anaphylaxis.
The company expects approval to expand treatment access.
The organization is actively advancing commercial preparations in anticipation of potential regulatory approval and market launch.
The company stated its planned regulatory submission to Health Canada remains on track for the fourth quarter of 2026.
