Aquestive Therapeutics, Inc. 8K

Aquestive Therapeutics reported positive human factors and pharmacokinetic study results for Anaphylm sublingual film that are intended to support resubmission of its NDA to the FDA in Q3 2026 following a prior Complete Response Letter.

Aquestive Therapeutics, Inc. announced positive topline results from a new human factors validation study and a pharmacokinetic study for its investigational product Anaphylm (dibutepinephrine) sublingual film, showing that revised packaging and instructions for use substantially improved ease and correctness of administration and that self-administered pharmacokinetics were comparable to clinician-administered dosing and intramuscular epinephrine, including clinically meaningful pharmacodynamic responses even with incorrect top-of-tongue placement; these data are intended to address deficiencies cited in a January 2026 FDA Complete Response Letter and support a planned resubmission of the Anaphylm NDA in the third quarter of 2026 and parallel regulatory efforts in Canada, the UK, and the EU.

Filing Facts

CIK

1398733

Ticker

-

Form

8K

Source Type

sec

Accession

0001398733-26-000035

Alert Tier

6