Aquestive up 9% premarket on abbreviated pathway for AQST-108

Aquestive Therapeutics (NASDAQ:AQST) is up 9% premarket on modest volume on the heels of its announcement that the FDA has signed off on the abbreviated 505(b)(2) registration pathway for AQST-108, an oral sublingual film formulation of epinephrine for the potential treatment of anaphylaxis (serious allergic reaction).

Epinephrine is typically administered via subcutaneous injection in an emergency setting.

The 505(b)(2) pathway allows for the inclusion of data generated by others.

The company will move forward with an IND and plans to launch pivotal pharmacokinetic studies before year-end.

https://seekingalpha.com/news/3539140-aquestive-up-9-premarket-on-abbreviated-pathway-for-aqstminus-108