Aquestive Therapeutics' (AQST) Anaphylm sublingual film, a potential treatment for life-threatening allergic reactions, showed improvements in addressing issues identified by the US Food and Drug Administration in a human factors validation study and pharmacokinetic study, the company said Monday.

The median time to open a pouch decreased to three seconds from 17 seconds and the number of participants who had difficulty opening the pouch decreased to one out of 105 from 26 out of 166, the company said.

Only two out of 105 participants incorrectly administered the film in the mouth, down from 20 out of 166, the company said.

The results "reinforce our confidence in the revised packaging design and instructions for use as we prepare for our planned new drug application resubmission," said Daniel Barber, president and chief executive officer.

The company said it remains on track to resubmit its new drug application for Anaphylm in the third quarter of 2026.

Shares of the company were up more than 10% in recent premarket trading.