Aquestive Therapeutics (NASDAQ:AQST) said it plans to resubmit its new drug application for Anaphylm, its epinephrine sublingual film candidate for type 1 allergic reactions including anaphylaxis, before the end of the third quarter after completing studies requested by the U.S. Food and Drug Administration.
President and Chief Executive Officer Dan Barber said the resubmission will come less than eight months after the company received a complete response letter from the FDA. The agency had cited issues involving pouch opening and administration of the film under the prior packaging and instructions for use.
Anaphylm Studies Support Planned Resubmission
The company also reported fewer administration errors. Under the earlier packaging, 20 participants placed the film on top of the tongue or roof of the mouth instead of in the intended location. In the latest study, two participants misplaced the dose, Barber said.
A separate pharmacokinetic study found no statistical difference between clinician-administered and self-administered Anaphylm, according to the company. Participants who self-administered the product used the revised packaging and instructions without coaching from clinical staff.
Aquestive also evaluated a scenario in which clinicians intentionally placed the film on top of a subject’s tongue. Barber said the company observed rapid and meaningful changes in blood pressure and heart rate, with changes from baseline higher than manual intramuscular epinephrine during the first 15 minutes and in line with EpiPen findings from other company studies. He added that, while drug levels were lower than with intended sublingual administration, the study still reached what the company described as meaningful maximum concentration levels.
Chief Medical Officer Matt Greenhawt said the data were reassuring because they showed a pharmacodynamic response even when the product was administered in a manner not intended for use. He said the results could help clinicians counsel patients and families about the product if it is approved.
Management continues to use a six-month FDA review as its base-case assumption. Barber said the company will discuss whether the agency could review the resubmission more quickly because it expects to submit a focused package addressing the complete response letter. Senior Vice President of Regulatory Affairs Melina Cioffi said the FDA has discretion to classify a resubmission as either a two-month Class 1 review or a six-month Class 2 review.
Launch and Market Preparation
Barber said Aquestive is preparing for a potential Anaphylm launch through an allergist-focused approach, which it believes could help limit cash burn. The company believes the epinephrine rescue market has grown about 6% annually in recent years, including in 2026 year to date, and estimated that the opportunity for branded epinephrine products exceeds $1 billion annually and could potentially reach $2 billion over time.
The company said it is developing its pricing strategy and cited what it views as clinical differentiation, ease of carrying the product and ease of use as factors that could be relevant in payer discussions. Chief Commercial Officer Sherry Korczynski said the company is preparing sales leadership, training, promotional materials and commercial analytics while managing timing scenarios around a potential FDA decision.
Questoive also said it is pursuing partnerships for Libervant in the U.S. and for Anaphylm outside the U.S. Cioffi said the company expects to begin regulatory processes for Anaphylm in Canada, Europe and the U.K. in the fourth quarter. She said the company has engaged with health authorities in those regions and that they indicated the existing data package could support filings.
Second-Quarter Financial Results
Chief Financial Officer Ernie Toth reported second-quarter revenue of $13.8 million, up 38% from $10 million a year earlier. Manufacture and supply revenue rose to $11.9 million from $9.6 million, primarily due to higher Suboxone revenue, partly offset by lower Ondif revenue. License and royalty revenue increased to $1.3 million from $0.8 million, primarily reflecting royalties from Zevra.
Research and development expense declined slightly to $4 million from $4.1 million, while selling, general and administrative expense increased to $14.1 million from $12.7 million. The increase in SG&A included higher legal fees, severance costs, personnel expenses and share-based compensation, partly offset by lower commercial spending and lower regulatory and licensing fees.
- Net loss was $22.9 million, or $0.18 per share, compared with a net loss of $13.5 million, or $0.14 per share, in the prior-year quarter.
- The quarter included an $11.7 million one-time loss on extinguishment of debt related to the payoff of the company’s 13.5% notes.
- Excluding that debt-extinguishment loss, net loss was $11.2 million, according to the company.
- Non-GAAP adjusted EBITDA loss improved to $5.2 million from $9.3 million a year earlier.
- Cash and cash equivalents totaled $98.5 million at June 30.
During the quarter, Aquestive completed a refinancing with Oaktree that established a new $150 million debt facility. Toth said the facility lowered the company’s cost of capital, extended its interest-only period and increased financial flexibility.
The company maintained its full-year 2026 guidance for revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $30 million to $35 million. Management also said it expects $75 million in launch funding from RTW and $20 million from Oaktree following FDA approval of Anaphylm, subject to applicable funding conditions.
AQST-108 Development
Aquestive said it expects to provide further updates later this year on AQST-108, a topical epinephrine program being evaluated initially for atopic dermatitis. Barber said the company views atopic dermatitis as an entry indication that could support broader dermatology development.
Chief Development Officer Matthew Davis said early human studies showed suppression of TSLP, CCL3 and CCL4, while preclinical work showed NF-κB modulation. He said the company believes local delivery and a potential depot-like effect could support an extended dosing profile, though further study is planned.
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.
