Aquestive Therapeutics Q1 Earnings Call Highlights

Aquestive Therapeutics (NASDAQ:AQST) said it remains connected way to resubmit its caller cause exertion for Anaphylm, its epinephrine sublingual movie for terrible allergic reactions, successful the 3rd 4th of 2026, portion reporting higher first-quarter gross and a narrower nett loss.

On the company’s first-quarter net call, Chief Executive Officer Dan Barber said Aquestive has made “significant” advancement since its anterior update, including completing a Type A face-to-face gathering with the U.S. Food and Drug Administration, holding a teleconference with the U.K. Medicines and Healthcare products Regulatory Agency, submitting a pediatric investigational program to the European Medicines Agency and submitting its quality factors protocol to the FDA.

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Barber said Aquestive presently expects to person quality factors information and perchance pharmacokinetic information for Anaphylm disposable successful clip for its August net call. He said that timeline depends connected the FDA providing timely feedback connected the company’s quality factors protocol and that feedback being wrong expectations.

“With these assumptions successful mind, we proceed to usher to a 3rd 4th resubmission to the FDA, recognizing this timing remains taxable to FDA feedback and ongoing reappraisal processes,” Barber said.

Anaphylm resubmission remains cardinal absorption

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Aquestive received a implicit effect missive from the FDA for Anaphylm connected Jan. 30, 2026. Chief Financial Officer Ernie Toth said the institution has since aligned with the bureau connected remaining requirements for approval, including a quality factors validation survey and a pharmacokinetic study, some of which are underway.