AQST Investor Alert: AQUESTIVE THERAPEUTICS, INC. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Concealed Anaphylm NDA Deficiencies: Levi & Korsinsky

Disclosure Under Scrutiny: Were Risk Warnings Adequate for Aquestive's Anaphylm NDA?

NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP examines the adequacy of Aquestive Therapeutics, Inc.'s (NASDAQ: AQST) risk disclosures during the period from June 16, 2025 through January 8, 2026. Shareholders who lost money on AQST stock may find out if you qualify for a free case evaluation or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

Aquestive shares fell from $6.21 to $3.91 on January 9, 2026, a single-day loss of $2.30 per share (over 37%), after the FDA flagged deficiencies in the Anaphylm NDA that precluded labeling discussions. The lead plaintiff deadline is May 4, 2026.

What the Company Disclosed

Aquestive's SEC filings contained standard risk factor language acknowledging that drug development is inherently uncertain and that the FDA may not approve products on the expected timeline. These disclosures followed a familiar pattern for pharmaceutical companies: broad, generalized warnings about regulatory risk without identifying specific, known problems already affecting the application under review.

Throughout the Class Period, management repeatedly told investors that the Anaphylm NDA review was "on track" and that interactions with the FDA reflected nothing beyond routine back-and-forth.

Why Generic Warnings May Not Protect

The complaint challenges the notion that boilerplate risk factors satisfied Aquestive's disclosure obligations. When a company possesses specific data showing that its product faces identifiable hurdles with a regulatory reviewer, general statements that "the FDA may not approve our products" do not alert investors to the actual risk profile. The lawsuit maintains that investors were entitled to know about any concrete HF study results that the FDA would later cite as deficiencies.

"Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company's operations. When the data from the human factors study revealed identifiable concerns that the FDA later acted upon, investors deserved to understand the real risk to the Anaphylm approval timeline." -- Joseph E. Levi, Esq.

Evaluate whether you can recover losses in the AQST securities action or call Joseph E. Levi, Esq. at (212) 363-7500.

LEAD PLAINTIFF DEADLINE: May 4, 2026

Levi & Korsinsky, LLP, Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered for investors.

CONTACT:

Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171

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