Aquestive Therapeutics (NASDAQ: AQST) Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics (NASDAQ: AQST) Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual Film * Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026 * FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission >"This resubmission reflects the rigor of our response to the FDA's Complete Response Letter, and we believe it addresses the items identified by the FDA in the Complete Response Letter," said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. "The completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use, including reducing median pouch-opening time from 17 seconds to 3 seconds. Our conviction in Anaphylm's potential has never been stronger. As we prepare for a focused, allergist-first launch, if approved, we are moving with urgency to bring Anaphylm to the patients who need it most." Full press release available [HERE](https://www.globenewswire.com/news-release/2026/09/17/3363841/0/en/aquestive-therapeutics-announces-resubmission-of-new-drug-application-to-fda-for-anaphylm-dibutepinephrine-sublingual-film.html). For resubmissions, the FDA conducts its initial review within 30 days. After the initial 30-day review, they issue the resubmission classification and new PDUFA date. Class 2 resubmissions have a review period of 6 months after receipt of the resubmission. FDA should notify the company of the new PDUFA date by mid-October. If they classify it as a Class 2 resubmission, the new PDUFA date would be around mid-March 2027.