Aquestive Sets March 2027 FDA Date for Anaphylm After NDA Resubmission

Aquestive Therapeutics (NASDAQ: AQST) resubmitted its New Drug Application for Anaphylm in the third quarter of 2026, setting a March 16, 2027, FDA action date for the investigational sublingual film. The company said launch preparations remain on track for a potential rollout following approval, while its quarter-end cash balance of $90.3 million and a subsequent Libervant licensing transaction are expected to support the regulatory process and launch activities.

Anaphylm, or dibutepinephrine sublingual film, is being developed to treat severe allergic reactions, including anaphylaxis. The FDA is reviewing the Class 2 resubmission after issuing a Complete Response Letter on January 30, 2026. Aquestive said the application includes human-factors, pharmacokinetic and pharmacodynamic data intended to address the agency’s identified deficiencies.

The company is also preparing its first regulatory application for Anaphylm outside the United States, with a Health Canada submission planned for the fourth quarter of 2026. Anaphylm remains investigational, and its safety and efficacy have not been established.

Launch preparations and pipeline plans

Aquestive’s pre-commercial work includes scientific education, prescriber engagement, patient-support planning and discussions with payers. Year to date, the company reported more than 1,090 prescriber interactions and 876 booth engagements across 50 attended or planned conferences. It also drafted 14 manuscripts and submitted 10 conference abstracts.

A company-sponsored, double-blinded preference survey involving 27 adults at risk for anaphylaxis and 26 caregivers of pediatric patients found that 51 of the 53 respondents preferred a film format when asked to compare unlabeled placebo film with an empty, unlabeled nasal-spray device under controlled assumptions. Aquestive cautioned that the results reflect stated preferences and do not demonstrate prescribing behavior, utilization, clinical outcomes or commercial adoption.

Beyond Anaphylm, the company plans additional preclinical and clinical studies for AQST-108, an epinephrine topical gel and part of its AdrenaVerse prodrug platform, during the first half of 2027.

Cash, manufacturing volumes and 2026 outlook

Aquestive ended the third quarter with $90.3 million in cash, compared with $98.5 million at the end of the second quarter and $121.2 million at the end of 2025. Quarterly manufacturing shipments totaled 25.831 million doses, down from 47.909 million in the second quarter and 43.801 million in the third quarter of 2025.

As of November 3, the company maintained its 2026 outlook for total revenue of approximately $46 million to $50 million and a non-GAAP adjusted EBITDA loss of approximately $30 million to $35 million.

In October, Aquestive completed an out-licensing transaction for Libervant that provided $10 million in upfront nondilutive capital. The agreement also includes the potential for as much as $47.5 million in contingent regulatory and sales-based milestone payments, along with mid-teens royalties on net sales. Those additional payments depend on regulatory actions and commercialization performance.

The company’s near-term outlook remains heavily dependent on regulatory outcomes. The FDA could determine that the Anaphylm resubmission does not fully address the Complete Response Letter, request additional data, studies or inspections, delay its decision or decline approval. If approved, the product would also face execution risks involving manufacturing, reimbursement, market acceptance and commercial supply. Aquestive also cited uncertainty around foreign regulatory requirements, AQST-108 study timing and results, Libervant approvals and commercialization, and its longer-term funding needs.