Aquestive Therapeutics (AQST) Company Report

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its lead asset, Anaphylm, on January 30th or 31st, requiring additional human factors work and a PK study.
The company anticipates resubmitting Anaphylm in Q3 2026, with FDA approval expected in Q1 2027.
Aquestive ended 2025 with over $121 million in cash, providing a comfortable balance to fund operations through 2026 and into 2027, supporting the Anaphylm launch.
The pipeline also includes Libervant, tentatively approved and awaiting competitor orphan drug exclusivity expiration in January 2027, and AQST108 (epinephrine topical gel) in Phase I for alopecia areata.

5 days ago

Transcript

Aquestive Therapeutics Provides Update on Anaphylm FDA Review and Financial Position

AQST

Product Launch

Guidance Update

New Projects/Investments

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its lead asset, Anaphylm, on January 30th or 31st, 2026.
The CRL requires additional human factors work and a PK study, which the company plans to complete in Q1 and Q2 2026.
Aquestive expects to resubmit Anaphylm to the FDA in Q3 2026, with anticipated approval in Q1 2027 based on a six-month review clock.
The company reported over $121 million in cash at the end of 2025, which is projected to fund operations through 2026 and into 2027 for the Anaphylm launch.
Aquestive's pipeline also includes Libervant, a diazepam buccal film with tentative FDA approval, awaiting the expiration of a competitor's orphan drug exclusivity in January 2027.

5 days ago

Transcript

Aquestive Therapeutics Provides Update on Anaphylm FDA Review and Financial Position

AQST

Product Launch

Guidance Update

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its lead asset, Anaphylm, on January 30th or 31st, 2026, requiring additional human factors work and a PK study.
The company plans to resubmit Anaphylm in Q3 2026, with an expected FDA approval in Q1 2027.
Aquestive ended 2025 with over $121 million in cash, providing a comfortable balance to support operations through 2026 and into 2027 for launch preparation.
Anaphylm is a sublingual epinephrine film for severe allergic reactions, designed for ease of use, portability, and rapid absorption, with a T-max of 12 minutes compared to 20 minutes for auto-injectors in studies.
Another product, Libervant, a diazepam buccal film for acute repetitive seizures, is tentatively approved by the FDA and is expected to come to market in the U.S. after a competitor's orphan drug exclusivity expires in January 2027.

5 days ago

Transcript

Aquestive Therapeutics Faces FDA Scrutiny for Anaphylm NDA

AQST

Legal Proceedings

Product Launch

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. following a significant 40% intraday plunge in its stock.
The stock decline occurred after the company disclosed that the U.S. Food and Drug Administration (FDA) identified deficiencies in its New Drug Application (NDA) for Anaphylm.
The FDA advised that these unidentified deficiencies currently prevent discussions of labeling and post-marketing requirements, raising concerns about the application’s approvability ahead of the January 31, 2026, PDUFA action date.

5 days ago

Press Release

Aquestive Therapeutics Provides Investor Presentation Update

AQST

Product Launch

New Projects/Investments

Aquestive Therapeutics received a Complete Response Letter (CRL) for Anaphylm on January 30, 2026, and plans to resubmit the New Drug Application (NDA) in Q3 2026, requesting expedited review.
The company reported $121.2 million in cash and cash equivalents at the end of 2025 and is well-capitalized to address the Anaphylm CRL, anticipating significant cash remaining at the end of 2026.
The investor presentation highlights a diversified pipeline with potential peak annual net sales from pipeline assets exceeding $1.5 billion, including Anaphylm (potential >$1 billion), Libervant® (potential >$500 million), and AQST-108 (potential >$100 million).
Anaphylm demonstrated rapid absorption, reaching peak absorption in 12 minutes and therapeutic blood concentrations in as little as 5 minutes, with 96% of survey respondents preferring Anaphylm in a hands-on preference survey.

5 days ago

8-K

Aquestive Therapeutics Under Investigation by Faruqi & Faruqi, LLP

AQST

Legal Proceedings

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST).
This investigation follows an approximate 40% intraday stock plunge after the company disclosed that the U.S. Food and Drug Administration (FDA) identified deficiencies in its New Drug Application (NDA) for Anaphylm, an experimental sublingual film.
The FDA's identified deficiencies currently prevent discussions of labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026, PDUFA action date.
Investors who suffered significant losses in Aquestive Therapeutics stock or options are encouraged to contact Faruqi & Faruqi to discuss their legal rights.

Feb 19, 2026, 2:13 PM

Press Release

Aquestive Therapeutics Appoints New Chief Medical Officer

AQST

Management Change

Hiring

Product Launch

Aquestive Therapeutics announced the appointment of Matthew Greenhawt, MD, MBA, MSc, as Chief Medical Officer on February 18, 2026.
Dr. Greenhawt, an internationally recognized expert in allergy and immunology, joins to support the Anaphylm™ (dibutepinephrine) sublingual film NDA resubmission and advance the company's clinical pipeline.
His expertise is considered invaluable as the company works towards FDA approval of Anaphylm, which, if approved, would be the first and only oral medication for the rescue treatment of severe allergic reactions.
Dr. Gary Slatko, the interim Chief Medical Officer, will remain with Aquestive's medical team to support the Anaphylm NDA resubmission and launch.

Feb 18, 2026, 12:00 PM

Press Release

Aquestive Therapeutics Under Investigation by Faruqi & Faruqi, LLP

AQST

Legal Proceedings

Product Launch

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST).
This investigation follows a 40% intraday stock plunge on Friday after the U.S. Food and Drug Administration (FDA) identified deficiencies in the New Drug Application (NDA) for Anaphylm, an experimental sublingual film.
The FDA's findings currently prevent discussions of labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026, PDUFA action date.
Investors who suffered significant losses in Aquestive Therapeutics stock or options are encouraged to contact Faruqi & Faruqi to discuss their legal rights.

Feb 15, 2026, 1:12 PM

Press Release

Aquestive Therapeutics Under Investigation Following FDA Anaphylm NDA Deficiencies

AQST

Legal Proceedings

Product Launch

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST).
This investigation follows an approximate 40% intraday stock plunge after the company disclosed that the U.S. Food and Drug Administration (FDA) identified deficiencies in its New Drug Application (NDA) for Anaphylm.
The FDA advised that these unidentified deficiencies currently prevent discussions of labeling and post-marketing requirements, raising concerns about the Anaphylm application's approvability ahead of the January 31, 2026, PDUFA action date.

Feb 4, 2026, 1:13 AM

Press Release

Aquestive Therapeutics Faces Fraud Investigation

AQST

Legal Proceedings

The Schall Law Firm is investigating Aquestive Therapeutics, Inc. (AQST) for potential violations of securities laws, focusing on whether the company issued false and/or misleading statements.
This investigation follows Aquestive's announcement on January 9, 2026, that the FDA identified deficiencies in its New Drug Application (NDA) for Anaphylm, which prevented discussions on labeling and post-marketing commitments.
The FDA did not specify the nature of these deficiencies.
Following this news, Aquestive's shares fell by more than 37% on the same day.