Aquestive (AQST) Up as Anaphylm Pivotal Study Meets Goals

Core Insights - Aquestive Therapeutics, Inc. (AQST) shares surged 16% on March 15 after achieving primary and secondary endpoints in a pivotal phase III clinical study for Anaphylm, a sublingual film for treating severe allergic reactions [1][4] - Anaphylm is positioned as a non-invasive alternative to traditional autoinjectors like EpiPen, offering potential advantages in convenience and speed of administration [1][2] Clinical Study Results - In the pivotal phase III study, Anaphylm demonstrated non-inferiority to leading autoinjectors immediately after administration and was consistently faster in reaching maximum concentration (Tmax) [1][2] - Tmax is a critical metric for assessing the absorption rate of epinephrine, essential for treating severe allergic reactions [2] - Anaphylm's exposure levels, measured by area under the curve (AUC), were comparable to autoinjectors for 30 minutes post-dosing, indicating similar efficacy [2] Regulatory Developments - The FDA provided positive feedback during a Type C meeting, outlining the necessary steps for a pre-new drug application (NDA) meeting in the latter half of the year [4] - The company plans to file an NDA for Anaphylm by the end of 2024, contingent on a successful pre-NDA meeting [4] - The FDA has recommended that the company initiate a pediatric study for Anaphylm after completing adult studies [4] Stock Performance - Over the past year, AQST shares have increased by 668.9%, contrasting with a 4.6% decline in the industry [4]