Aquestive posts Anaphylm study presentation on investor website

Reuters2026/08/10 11:08

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Aquestive Therapeutics published a presentation outlining improved human factors and PK results for Anaphylm (dibutepinephrine) sublingual film.
Data support a planned Anaphylm NDA resubmission in Q3 2026, less than eight months after the FDA’s January 2026 CRL.
Revised packaging cut median pouch-opening time to 3 seconds from 17 seconds in the prior study.
HF errors fell sharply: difficulty opening dropped to 1 of 105 from 26 of 166; incorrect placement to 2 of 105 from 20 of 166.
PK study: geometric mean Cmax 391.7 pg/mL self-administered vs 357.6 clinician-administered; median Tmax 12 minutes for both.
Manual IM comparator showed geometric mean Cmax 334.5 pg/mL; median Tmax 45 minutes.
Misplaced top-of-tongue arm reported Cmax above 100 pg/mL, median Tmax 35 minutes, clinically meaningful PD comparable to injectables.
Presentation posted on the Events and Presentations page of the Investor section: https://www.aquestive.com.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608100700PRIMZONEFULLFEED9806554) on August 10, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Aquestive posts Anaphylm study presentation on investor website

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