Aquestive Therapeutics announced that its management team will participate in four major investor conferences in March 2026, including TD Cowen, Leerink Partners, Citizens Life Sciences, and Barclays healthcare conferences. The company will conduct presentations and 1x1 meetings with investors to discuss its pharmaceutical pipeline and business developments.

Aquestive Therapeutics announced it will report Q4 2025 financial results on March 4, 2026, followed by a conference call on March 5. The company is advancing its Anaphylm™ (dibutepinephrine) sublingual film for severe allergic reactions and AQST-108 topical gel for dermatological conditions, with recent clinical data showing promising epinephrine plasma concentrations.

Aquestive Therapeutics announced it will present clinical data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting in Philadelphia. The data shows the product achieved clinically relevant epinephrine plasma concentrations without diastolic blood pressure dip, a significant finding for anaphylaxis treatment. If approved by the FDA, Anaphylm would be the first oral medication for severe allergic reactions.

Aquestive Therapeutics stock plunged approximately 40% after the FDA identified deficiencies in its New Drug Application for Anaphylm, an experimental sublingual film for severe allergic reactions. The FDA stated that unidentified deficiencies prevent discussions of labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026 PDUFA action date. Faruqi & Faruqi is investigating potential claims on behalf of investors who suffered significant losses.

Aquestive Therapeutics stock plunged approximately 40% after the FDA identified deficiencies in the company's New Drug Application for Anaphylm, an experimental sublingual film for severe allergic reactions. The FDA stated that unidentified deficiencies prevent discussions of labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026 PDUFA action date. Securities law firm Faruqi & Faruqi is investigating potential claims on behalf of investors who suffered significant losses.

The Schall Law Firm is investigating Aquestive Therapeutics for potential securities law violations following the company's announcement on January 9, 2026, that the FDA identified deficiencies in its NDA for Anaphylm without specifying details. The stock fell over 37% on the announcement, prompting the class action investigation into whether the company issued false or misleading statements.

Aquestive Therapeutics received an FDA letter identifying deficiencies in its Anaphylm (dibutepinephrine) sublingual film NDA that preclude labeling discussions, though the FDA confirmed its review remains ongoing with no final decision made. The company maintains confidence in Anaphylm's potential and is advancing global regulatory expansion in Canada, Europe, and the UK. Aquestive reported approximately $120 million in cash and cash equivalents as of December 31, 2025.

The food allergy market is expected to grow significantly by 2034, driven by emerging therapies, increased diagnoses, and rising treatment costs. The market was valued at USD 3 billion in 2024, with the US accounting for approximately 79% of the total market.

Aquestive Therapeutics received two new U.S. patents for Anaphylm, a sublingual film for treating severe allergic reactions, extending product protection through 2037. The FDA's PDUFA target action date is set for January 31, 2026.

Aquestive Therapeutics reports the FDA will not require an advisory committee meeting for its Anaphylm™ (dibutepinephrine) Sublingual Film, maintaining the PDUFA target action date of January 31, 2026. The product aims to be the first non-invasive, orally delivered epinephrine treatment for severe allergic reactions.

Aquestive Therapeutics secured a $75 million strategic funding agreement with RTW Investments to support the potential launch of Anaphylm, an innovative sublingual epinephrine film for treating severe allergic reactions, pending FDA approval.

Aquestive Therapeutics announced the promotion of Sherry Korczynski to Chief Commercial Officer, focusing on driving the commercial strategy for Anaphylm, a breakthrough oral epinephrine delivery product for anaphylaxis treatment.