Aquestive reports positive Anaphylm human factors and PK study results; NDA resubmission on track for Q3 2026

Aquestive Therapeutics, Inc.

Median pouch-open time cut from 17s to 3s; incorrect film placement down >80% in revised HF study.
PK study: self-admin Cmax 391.7 pg/mL vs clinician 357.6 and IM 334.5; Tmax 12 min vs 45 min for IM.
Top-of-tongue placement still gave Cmax >100 pg/mL and PD comparable to injectable epinephrine.
No serious adverse events or discontinuations in PK study; no administration errors in self-administration arm.
NDA resubmission on track for Q3 2026; also advancing filings in Canada, UK, EU.

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