Aquestive Therapeutics ($AQST) Anaphylm FDA Approval Timeline Case

Investors can submit applications for the lead plaintiff role.

D. New Jersey

Court

3:26-cv-02317

Case number

06/16/2025

Class period Start

01/08/2026

Class period End

05/05/2026

Lead Plaintiff motion deadline

$AQST investors filed a claim against Aquestive Therapeutics for allegedly misleading investors about the approval timeline for its Anaphylm allergy treatment.
After the company disclosed that the FDA identified deficiencies in its drug application that delayed approval, $AQST fell 37.0% on January 9, 2026, closing at $3.91 per share.
$AQST investors can join this case to be notified about potential recovery.
Case Details:

Between June 16, 2025 and January 8, 2026, Aquestive Therapeutics told investors its New Drug Application for Anaphylm—a sublingual epinephrine film for severe allergic reactions—was progressing smoothly toward FDA approval. Executives repeatedly emphasized that the regulatory review was on track and expressed confidence the drug would be approved by the January 31, 2026 FDA decision deadline.

However, during this period, investors allege the regulatory outlook was not as certain as the company suggested. Aquestive Therapeutics allegedly failed to disclose: (1) that the FDA had identified deficiencies related to human factors involved in using the product; (2) that issues involving packaging, administration, and labeling could prevent approval discussions from advancing; and (3) that these problems created a significant risk the drug would not be approved by the expected deadline.

Then, on January 9, 2026, the company revealed it had received a letter from the FDA identifying deficiencies in the Anaphylm application that prevented labeling discussions and indicated the agency had not reached a final decision. $AQST fell 37.0%, closing at $3.91. 

Additional revelations followed on February 2, 2026, when the company disclosed the FDA had issued a Complete Response Letter citing human-factor study problems, including difficulty opening packaging and incorrect film placement. By January 9, 2026, shares had dropped to $3.91, representing a total decline of 37.0% over the correction period.

Based on these events, $AQST investors filed a claim against Aquestive Therapeutics, alleging the company:
It misled investors about the likelihood and timing of FDA approval for Anaphylm.
It downplayed regulatory concerns about product usability, packaging, and labeling that could delay approval.
It caused investors to purchase shares at inflated prices before the regulatory problems became public.
Investors argue Aquestive Therapeutics misled the market about the regulatory readiness of Anaphylm and the likelihood of timely FDA approval, causing losses when the truth emerged.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Submission

Alleged Offence

Misleading Statements,

Fraud,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

01/09/2026

Filing date

03/05/2026

Lead Plaintiff Deadline

05/05/2026

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