Aquestive Therapeutics (AQST) Company Report

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.

6 hours ago

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.

1 day ago

Press Release

Aquestive Receives FDA Complete Response Letter for Anaphylm

AQST

Product Launch

New Projects/Investments

Guidance Update

Aquestive received a Complete Response Letter (CRL) from the FDA on January 30, 2026, for its Anaphylm™ (dibutepinephrine) Sublingual Film, with deficiencies focused on packaging and administration.
The FDA requires Aquestive to conduct a new Human Factors validation study and a clinical pharmacokinetic (PK) study to address issues such as pouch opening, film tearing, incorrect placement, chewing, and tolerability.
Aquestive anticipates resubmitting the New Drug Application (NDA) as early as Q3 2026 and plans to make ex-U.S. regulatory filings in Canada and Europe in the second half of 2026.
The company states it remains well-capitalized and expects to end 2026 with significant cash.

2 days ago

Presentation

Aquestive Therapeutics Receives FDA Complete Response Letter for Anaphylm

AQST

Product Launch

Guidance Update

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its Anaphylm Epinephrine Sublingual Film application.
The CRL primarily cited deficiencies related to human factors, including concerns about pouch opening, film tearing, administration location, and potential chewing or premature removal of the film.
The FDA did not identify deficiencies concerning pharmacokinetic (PK) bracketing, repeat dose safety, sustainability of Anaphylm's performance, or CMC aspects.
Aquestive plans to address the CRL by conducting an additional human factors validation study and a pharmacokinetic study related to film placement.
The company anticipates resubmitting the application by the third quarter of 2026 , which will be a Class 2 resubmission with a standard six-month review period.

2 days ago

Transcript

Aquestive Therapeutics Receives Complete Response Letter for Anaphylm

AQST

Product Launch

Guidance Update

New Projects/Investments

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its Anaphylm Epinephrine Sublingual Film application, indicating that additional work is required prior to approval.
The FDA cited no deficiencies regarding pharmacokinetic (PK) bracketing, repeat dose safety, sustainability of Anaphylm's performance, or CMC comments, which the company believes validates major CMC safety and efficacy data.
The issues raised in the CRL primarily concern human factors, including packaging, use, administration, and labeling feedback.
Aquestive plans to resubmit the application by the third quarter of 2026, following the completion of a human factors validation study (expected 75 participants) and a single pharmacokinetic study (expected 18-24 participants per arm).
The company anticipates a six-month review time for the resubmission and will also progress ex-US filings in Canada and Europe this year.

2 days ago

Transcript

Aquestive receives FDA Complete Response Letter for Anaphylm

AQST

Product Launch

New Projects/Investments

Aquestive received a Complete Response Letter (CRL) from the FDA for its Anaphylm Epinephrine Sublingual Film application, indicating the need for additional work prior to approval.
The CRL primarily cited concerns related to human factors, including issues with pouch opening, potential film tearing, administration location, chewing of the film, and tolerability (tingling, burning, taste). However, the FDA did not cite deficiencies regarding pharmacokinetic (PK) bracketing, repeat dose safety, sustainability of performance, CMC comments, or overall safety profile.
Aquestive plans to address the CRL by conducting a human factors validation study and a single pharmacokinetic study, with an expected resubmission by the third quarter of 2026.
The company views the CRL as a major de-risking event towards approval, with a straightforward path to resubmission, and will also progress ex-US filings in Canada and Europe this year.

2 days ago

Transcript

Aquestive Therapeutics Receives FDA Complete Response Letter for Anaphylm

AQST

Product Launch

Guidance Update

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA on January 30, 2026, for its New Drug Application (NDA) for Anaphylm™.
The FDA's concerns were limited to packaging and administration issues, specifically deficiencies in the human factors validation study.
The company expects to resubmit the NDA as early as Q3 2026 after resolving the deficiencies, which include modifying packaging and conducting new human factors and pharmacokinetics studies.
Aquestive also plans to submit for regulatory approval of Anaphylm in Canada and Europe in the second half of 2026.

2 days ago

8-K

Aquestive Therapeutics Receives FDA Complete Response Letter for Anaphylm™

AQST

Guidance Update

New Projects/Investments

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA on January 30, 2026, for its Anaphylm™ New Drug Application (NDA).
The CRL cited deficiencies related to human factors (HF) validation study (packaging and administration) and requested a single pharmacokinetics (PK) study.
The company anticipates resolving these issues and resubmitting the NDA as early as Q3 2026.
Aquestive expects to remain well-capitalized and end 2026 with significant cash.
International regulatory submissions for Anaphylm in Canada and Europe are planned for the second half of 2026.

2 days ago

Press Release

Aquestive Therapeutics Faces Legal Investigation Following FDA Concerns on Anaphylm NDA

AQST

Legal Proceedings

Product Launch

Guidance Update

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST).
This investigation follows a significant 40% intraday plunge in Aquestive Therapeutics shares on January 29, 2026.
The stock drop occurred 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 for severe allergic reactions.
The FDA's findings currently prevent discussions of labeling and post-marketing requirements, raising concerns about Anaphylm's approvability ahead of the January 31, 2026, PDUFA action date.

6 days ago

Press Release

Aquestive Therapeutics Under Investigation Following FDA Deficiencies for Anaphylm NDA

AQST

Legal Proceedings

Faruqi & Faruqi, LLP is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST).
Shares of Aquestive Therapeutics plunged approximately 40% intraday on Friday 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.

Jan 26, 2026, 1:24 AM

Press Release