Aquestive Therapeutics Eyes Q3 Anaphylm FDA Resubmission, 2027 Launch

Aquestive Therapeutics (NASDAQ:AQST) used its 2026 annual meeting of stockholders to provide a brief update on its lead product candidate, Anaphylm, and to report preliminary voting results on board elections, executive compensation and the company’s auditor.

Dr. Gregory Brown, chair of the board, opened the virtual meeting and said there would be no separate management presentation after the formal portion. He noted that directors and senior executives were in attendance, along with representatives from KPMG LLP, Aquestive’s independent public accounting firm.

Chief Executive Officer Dan Barber said Aquestive is “quickly approaching” its ninth year as a public company and called the current period “the most exciting time in the history of Aquestive.” He said the company has progressed significantly as it works toward FDA acceptance of its new drug application for Anaphylm, described in the meeting as the company’s lead product candidate for the treatment of severe allergic reactions, including anaphylaxis.

Anaphylm NDA Resubmission Expected in Third Quarter

Barber said Aquestive anticipates resubmitting its application to the FDA in the third quarter of this year. If approved, he said Anaphylm would be the “first and only non-device-based oral medication” indicated for severe allergic reactions, including anaphylaxis.

He also said the company is increasingly focusing on commercial preparations for a potential launch “as early as possible in 2027,” assuming FDA approval. Barber said the company will emphasize awareness among patients and caregivers around the portability of Anaphylm.

“If approved by the FDA, Anaphylm is the only product that allows for not just one, but two doses to easily fit on the back of your phone, into a wallet or a small purse, providing patients with epinephrine that can be with them anytime, anywhere,” Barber said.

Barber said Aquestive has taken several steps to prepare for a potential launch, including building a medical affairs presence, developing a pre-launch awareness platform, using existing payer relationships to prepare for patient access, building product messaging and advertising, and establishing relationships with advocacy groups. He said the company expects to launch Anaphylm with a 75-person sales force if approved.

Company Cites Regulatory Progress Outside the U.S.

Barber also highlighted progress in international regulatory discussions. He said interactions in the U.K., Europe and Canada have confirmed that no further clinical work is necessary in those regions for submitting an application for Anaphylm.

If approved in each of those regions, Barber said Anaphylm could be available to almost 1 billion people “in the next couple of years.”

Pipeline Update Includes AQST-108

Barber said Aquestive is using its epinephrine prodrug platform, AdrenaVerse, to pursue potential additional indications. He identified AQST-108 as the company’s lead asset within that effort.

According to Barber, Aquestive recently completed a Phase 1 safety study of AQST-108 in men with androgenic alopecia. He said the study showed no drug-related adverse events and no appreciable systemic absorption. Barber also said early biomarker data “showed promise,” and that the company would share more about the next studies for AQST-108 after resubmitting the Anaphylm application in the U.S.

Stockholders Approve All Proposals

Lori Braender, Aquestive’s corporate secretary, said Broadridge confirmed that the meeting notice and notice of internet availability of proxy materials were sent to stockholders of record as of April 13, 2026. She said at least 80,061,326 shares, or approximately 64% of the company’s outstanding stock, were present in person or represented by proxy, establishing a quorum.

Stockholders voted on three proposals outlined in the company’s proxy statement:

  • The election of Class II directors Dr. Gregory Brown, John Cochran and Abigail Jenkins.
  • An advisory vote on the compensation of the company’s named executive officers.
  • The ratification of KPMG LLP as the company’s independent public accounting firm for the current fiscal year.

Braender reported preliminary results showing that Brown, Cochran and Jenkins each received at least 36 million votes, representing at least 86% of the votes cast in the election, and were elected as Class II directors. The advisory vote on executive compensation received support from not less than 92% of votes cast. The ratification of KPMG received support from not less than 98% of votes cast.

Braender said Aquestive will report the final vote tally in a Form 8-K to be filed with the Securities and Exchange Commission within four business days of the meeting.

After the formal business concluded, the company opened a general question-and-answer session. No questions were submitted, and the meeting was adjourned.

About Aquestive Therapeutics (NASDAQ:AQST)

Aquestive Therapeutics, Inc is a specialty pharmaceutical company focused on the development and commercialization of novel drug delivery systems. Leveraging its proprietary PharmFilm® technology, Aquestive designs thin-film formulations that facilitate sublingual, buccal and oral delivery of small molecules, offering rapid onset of action and improved patient compliance compared with traditional dosage forms.

The company’s lead product, Libervant® (diazepam) Buccal Film, is approved by the U.S.