Anaphylm Study Success Clears Path for FDA Resubmission, Shares Jump 13%
AQST sits 52% above its 52-week low of $2.93 on elevated volume (2.9× avg).
Summary
Aquestive's human factors and PK studies for its epinephrine sublingual film Anaphylm delivered strong results, directly addressing FDA concerns that led to a Complete Response Letter in January 2026. The redesigned packaging cut median opening time from 17 seconds to 3 seconds, with near-elimination of user errors like improper placement or chewing. Pharmacokinetic data showed that even misplaced administration achieved clinically meaningful epinephrine levels, with no serious adverse events. The company confirmed it remains on track for an NDA resubmission in Q3 2026, while also pursuing approvals in Canada, the UK, and the EU. Shares rose 13.45% on the news, reflecting renewed confidence in the program's regulatory path. This follows the 8-K filed earlier today, adding granular study data and market reaction.
At the time of this announcement, AQST was trading at $4.46 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $559M. The 52-week trading range was $2.93 to $7.55. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Benzinga.