Aquestive Therapeutics, Inc. filings document the regulatory, financial, governance, and capital-structure disclosures of a specialty pharmaceutical company built around oral-film drug delivery, proprietary product candidates, and CDMO/licensee manufacturing. Its 8-K reports include FDA communications and Regulation FD materials for Anaphylm™, financial results, investor presentations, and material agreements related to revenue-sharing, warrants, and common-stock purchase commitments.
Proxy materials describe annual-meeting voting matters, director elections, executive compensation, auditor ratification, and board governance. Other current reports record officer-transition matters, compensatory arrangements, exhibits, and product-development updates tied to the company’s regulatory strategy.
Aquestive Therapeutics Chief Commercial Officer Sherry Korczynski reported a mix of equity awards and related share sales. She received 75,000 shares of restricted common stock and a non-qualified stock option for 42,500 shares at $4.29 per share, vesting in three annual installments of 25%, 25% and 50%. In connection with the vesting of restricted stock units, she sold 15,741 common shares at a weighted average price of $4.173 per share to cover tax withholding obligations under the company’s equity plan, which the footnotes state were mandated “sell to cover” transactions rather than discretionary trades. After these transactions, she directly holds 241,117 common shares and the newly granted option expiring in 2036.
Aquestive Therapeutics, Inc. Chief Operating Officer Cassie Jung reported a combination of equity grants and a mandated share sale. She received 80,000 shares of restricted common stock and a non-qualified stock option for 42,500 shares at an exercise price of $4.29 per share, vesting over three annual installments. To cover tax withholding from restricted stock unit vesting, she sold 45,791 shares of common stock at a weighted average price of $4.173 per share in transactions described as required "sell to cover" trades rather than discretionary sales. After these moves, she directly holds 274,980 common shares and indirectly holds 2,000 shares through her spouse, along with the newly granted option expiring on March 9, 2036.
Aquestive Therapeutics, Inc. reported that its Chief Development Officer, Matthew W. Davis, received new equity compensation. On March 9, 2026, he was granted a non-qualified stock option for 50,000 shares of common stock at an exercise price of $4.29 per share, expiring on March 9, 2036. He was also granted 50,000 shares of restricted common stock at no cash cost. The restricted stock will vest in three annual installments with 25% on the first installment, 25% on the second, and 50% on the third, and the option will vest on the same schedule. Following these grants, his direct common stock holdings reported in this filing total 100,000 shares.
Greenhawt Matthew J. reported acquisition or exercise transactions in this Form 4 filing.
Aquestive Therapeutics Chief Medical Officer Matthew J. Greenhawt received new equity awards. He was granted a non-qualified stock option for 50,000 shares of Common Stock at $4.29 per share, expiring on March 9, 2036. The option vests in three annual installments of 25%, 25%, and 50%.
He also received 75,000 shares of restricted Common Stock at no cost, vesting on the same 25%, 25%, and 50% schedule. Following these grants, he holds 75,000 shares of Common Stock directly, 50,000 option shares directly, and 2,000 shares indirectly through his spouse.
Aquestive Therapeutics, Inc. filed an initial ownership report for Chief Medical Officer Matthew J. Greenhawt. The filing shows indirect beneficial ownership of 2,000 shares of Common Stock held by his spouse. This Form 3 records an existing position and does not report any new purchase or sale.
Aquestive Therapeutics is a specialty pharmaceutical company focused on oral film delivery technologies, especially for CNS and allergy indications. It reported licensed product revenue of $44,545 in 2025 and $57,561 in 2024. As of June 30, 2025, non‑affiliate market value of common stock was about $291.6 million, with 122,045,049 shares outstanding as of March 2, 2026.
The lead epinephrine candidate Anaphylm received an FDA Complete Response Letter on January 30, 2026 citing human‑factors and labeling issues, not CMC or PK data. The company plans new human‑factors and PK studies and targets NDA resubmission in Q3 2026 while also pursuing EMA and Canadian submissions.
In epilepsy, buccal diazepam film Libervant had its approval for patients aged 2–5 years vacated by a U.S. District Court decision favoring a competitor’s orphan‑drug exclusivity, converting Libervant to tentative approval and halting U.S. marketing. Aquestive retains ex‑U.S. rights via partners and continues to develop its AdrenaVerse epinephrine prodrug platform, including topical gel AQST‑108.
Aquestive Therapeutics reported fourth-quarter 2025 revenue of $13.0 million, up from $11.9 million, and full-year 2025 revenue of $44.5 million, down from $57.6 million after a prior-year deferred revenue benefit. Full-year GAAP net loss widened to $83.8 million from $44.1 million, driven mainly by higher selling, general and administrative costs, including about $14.3 million of one-time legal expenses and increased Anaphylm launch preparation spending.
The company ended 2025 with $121.2 million in cash and cash equivalents and guided 2026 revenue to $46–$50 million and non-GAAP adjusted EBITDA loss to $30–$35 million. Aquestive received an FDA Complete Response Letter for Anaphylm in January 2026 focused on human factors and requested a pharmacokinetic study, and now plans to resubmit its NDA in the third quarter of 2026. To support its RTW revenue-sharing arrangement and liquidity, Aquestive extended the Anaphylm marketing approval deadline to June 30, 2027, agreed to issue RTW a warrant for up to 375,000 shares at $4.00 per share expiring in 2029, and obtained a commitment from RTW-affiliated funds to purchase at least $5 million of common stock over a 90-day period.
Aquestive Therapeutics furnished an investor presentation outlining its strategy and pipeline, highlighted by Anaphylm, a sublingual epinephrine film for severe allergies that received a Complete Response Letter from the FDA on January 30, 2026. The company expects to resubmit the New Drug Application for Anaphylm in Q3 2026 and is planning for a potential U.S. launch in 2027 if approved.
The presentation emphasizes a diversified portfolio including Libervant for acute repetitive seizures and AQST-108, a topical epinephrine gel initially targeting alopecia areata. Aquestive reports finishing 2025 with $121 in cash and cash equivalents and describes itself as well-capitalized to complete required Anaphylm work in 2026. Management also cites more than $1.5 billion in potential peak annual net sales from pipeline assets and key upcoming clinical, regulatory and commercialization milestones through 2027.
Aquestive Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter on January 30, 2026 for its New Drug Application for Anaphylm (dibutepinephrine) sublingual film to treat Type I allergic reactions, including anaphylaxis, in patients weighing at least 30kg. The company states that FDA-identified deficiencies are limited to packaging and administration and believes these can be resolved, with a resubmission targeted as early as the third quarter of 2026.
Aquestive is also advancing a global strategy for Anaphylm, having begun regulatory engagement in Canada, Europe and the United Kingdom in 2025, and it plans to seek regulatory approvals in Canada and Europe in 2026. The company furnished a press release and investor presentation as exhibits to provide additional details.
Aquestive Therapeutics disclosed that the U.S. FDA has identified deficiencies in its New Drug Application for Anaphylm, an epinephrine sublingual film for severe allergic reactions, including anaphylaxis. The FDA indicated that these deficiencies, which were not specified, currently prevent discussions about labeling and post‑marketing commitments, and it stated that its review is ongoing and no final decision has been made.
The company is working to understand and address the FDA’s concerns ahead of the scheduled PDUFA goal date of January 31, 2026, but noted this development could delay a possible approval of the Anaphylm NDA. Aquestive also highlighted progress on its global strategy, having begun regulatory engagement in Canada, Europe and the United Kingdom in 2025 and planning to seek approvals in Canada and Europe in 2026. It reported approximately $120 million in cash and cash equivalents as of December 31, 2025, and believes this provides sufficient capital to pursue its long-term strategy.