Aquestive Therapeutics, Inc. (AQST)

Over the past six months, Aquestive Therapeutics' stock price has been significantly impacted by several events. On January 9, 2026, the FDA identified deficiencies in the NDA for Anaphylm, causing AQST's stock to drop. In November 2025, Aquestive Therapeutics reported its Third Quarter 2025 financial results and provided a business update. In September 2025, the FDA decided not to require an Advisory Committee meeting for the approval of Anaphylm, contributing to a stock surge. In August 2025, the company's liquidity was boosted by an $85 million net proceeds share offering. In May 2025, Aquestive reported its First Quarter 2025 financial results and provided a business update, including the submission of the NDA for Anaphylm.

There is an indication of demand seasonality for Aquestive Therapeutics' products, specifically for Anaphylm. The company anticipates ramping up commercialization efforts for Anaphylm in the first quarter of 2026, ahead of the peak spring allergy season, suggesting that demand for this severe allergy treatment may be higher during certain times of the year.

Aquestive Therapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing medicines for critical healthcare problems, particularly in CNS conditions and severe allergies, including anaphylaxis. The company's commercialized product portfolio includes Libervant, Suboxone, Sympazan, KYNMOBI, and Azstarys. The company's proprietary pipeline products include Anaphylm (dibutepinephrine) Sublingual Film and AQST-108. Aquestive Therapeutics leverages its proprietary PharmFilm® technology for drug delivery.

The majority of Aquestive Therapeutics' revenue is generated in the United States. The company is also pursuing global expansion for its pipeline product Anaphylm, with plans to submit applications for regulatory approval in Canada in the first half of 2026 and in Europe in the second half of 2026. Feedback from the UK's Medicines and Healthcare Products Regulatory Agency is anticipated in the first quarter of 2026.

Aquestive Therapeutics' brand reputation in the past year has been largely tied to the progress and setbacks of its lead pipeline product, Anaphylm. The FDA's acceptance of the Anaphylm NDA and the subsequent decision in September 2025 not to require an advisory committee meeting for its approval significantly boosted market sentiment and the company's reputation. The announcement on January 9, 2026, that the FDA identified deficiencies in the Anaphylm NDA has negatively impacted the company's reputation and stock price.

Aquestive Therapeutics, Inc. has a diverse ownership structure. Institutional shareholders hold approximately 54.16% of the stock, while insiders own about 6.24%, and retail investors account for 39.60%. Major institutional owners include Bratton Capital Management, L.P., BlackRock, Inc., RTW Investments, LP, Vanguard Group Inc., Perceptive Advisors Llc, EcoR1 Capital, LLC, Samsara BioCapital, LLC, and Geode Capital Management, Llc. Douglas K. Bratton is noted as the largest individual shareholder.