Aquestive's Anaphylm Resubmission Gets March 2027 PDUFA

The Tip Desk · November 10, 2026 · 3 min read

The FDA accepted the oral epinephrine film's Class 2 NDA resubmission as the company posted $7.6 million in third-quarter revenue.

Aquestive Therapeutics (AQST) said the U.S. Food and Drug Administration accepted its Anaphylm new drug application resubmission as a Class 2 response and assigned a Prescription Drug User Fee Act goal date of March 16, 2027.

The oral epinephrine film, which the company said would be the first and only oral rescue medication for severe allergic reactions including anaphylaxis if approved, had been stalled after a January 30, 2026 complete response letter. In the second quarter Aquestive completed the human factors validation and pharmacokinetic studies the agency required, then resubmitted on September 16, 2026.

President and Chief Executive Officer Daniel Barber said the company believes it has a clear path to making Anaphylm available to patients and caregivers if approved. Commercial preparations remain on track, the company said, including a field sales organization intended to engage allergists after approval. Outside the United States, Aquestive expects to file with Health Canada in the fourth quarter of 2026 and in the European Union in the first quarter of 2027.

Third-quarter revenue was $7.6 million, down 41% from $12.8 million a year earlier. The company attributed the decline primarily to a quarterly fluctuation in Suboxone product orders. Manufacture and supply revenue fell to $6.7 million from $11.5 million, which the company said reflected lower Suboxone revenues from the timing of product orders, partially offset by higher Ondif revenues. License and royalty revenue was $0.8 million.

Aquestive manufactured approximately 26 million doses in the third quarter, compared with approximately 44 million doses in the third quarter of 2025. On a year-to-date basis through September, it manufactured approximately 107 million doses, versus approximately 108 million in the same period a year earlier.

Gross margin on total revenue compressed to 52% from 65% a year earlier; non-GAAP gross margin on total revenue was 55%.

Net loss widened to $16.5 million, or $0.13 a share, from a net loss of $15.4 million, or $0.14 a share, in the third quarter of 2025. The company said the increase was driven primarily by lower revenues, partially offset by decreases in selling, general and administrative expenses, manufacture and supply expenses, and interest expense, and increases in interest income. Non-GAAP adjusted EBITDA loss was $12.2 million.

Selling, general and administrative expenses were $14.2 million. The company said the decrease from $15.3 million a year earlier primarily represented lower legal fees of about $1.5 million, lower commercial spending of about $1.4 million, and lower Anaphylm-related regulatory expenses of about $0.6 million, partially offset by higher personnel, share-based compensation, and consulting costs. Research and development expenses were $4.3 million.

Cash and cash equivalents were $90.3 million as of September 30, 2026. Full-year 2026 guidance remained unchanged at total revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $35 million to $30 million.

In October, after quarter-end, Aquestive granted Eton Pharmaceuticals exclusive U.S. commercialization rights to Libervant. The company received a $10 million upfront payment and remains eligible for up to $47.5 million in contingent regulatory and sales-based milestones and mid-teens royalties, while staying the exclusive manufacturer under a 20-year supply agreement. Libervant has received tentative FDA approval for patients two to five and twelve years of age and older; final FDA approval for patients twelve and older is subject to expiration of Valtoco orphan drug exclusivity on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027. Aquestive also submitted a Type 9 NDA to add patients six to eleven years of age, with a PDUFA goal date of March 29, 2027.

AQST-108, a topical epinephrine prodrug, is advancing in atopic dermatitis after a first-in-human study in which the company said no serious or topical adverse events were observed. Additional clinical work is expected to begin in the first quarter of 2027.