Aquestive Submits Anaphylm NDA To FDA Following Positive Topline Data From Pediatric Study

(RTTNews) - Aquestive Therapeutics, Inc. (AQST), Tuesday announced positive topline results from its pediatric study for Anaphylm sublingual film in patients aged seven to seventeen and weighing greater that thirty kilograms with a personal history of allergic reactions.

The findings revealed that Anaphylm was safe, well-tolerated, and consistent with pharmacokinetic profile in pediatric patients.

Following this, the company submitted the Anaphylm New Drug Application to the U.S. Food and Drug Administration, and expects to receive the acceptance in the second quarter of 2025.

In the pre-market hours, Aquestive's stock is trading at $2.94, up 1.38 percent on the Nasdaq.