Company Announcements

Key Dates and Disclosure Events Shareholders Need to Know

NEW YORK , April 30, 2026 /PRNewswire/ -- SueWallSt encourages investors who suffered losses in Aquestive Therapeutics, Inc. (NASDAQ: AQST) to contact the firm. Those who purchased AQST securities between June 16, 2025 and January 8, 2026 may be entitled to recover damages. Find out if you are eligible to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

AQST shares lost $2.30 per share in a single trading session, falling over 37% on January 9, 2026. The window to apply for lead plaintiff closes on May 4, 2026.

June 16, 2025: FDA Accepts Anaphylm NDA, PDUFA Date Set

Aquestive announced the FDA accepted its New Drug Application (NDA) for Anaphylm sublingual film and assigned a PDUFA goal date of January 31, 2026. The lawsuit contends that management used this milestone to begin building investor confidence in a near-certain approval timeline, while allegedly failing to address known deficiencies.

August 11-12, 2025: Q2 Earnings and "On Track" Assurances

Across a press release and earnings call spanning two days, management repeatedly told investors the Company was "on track" across every element of the Anaphylm program. As alleged, the Company characterized its FDA interactions as routine, stating there was "nothing new or of consequence" in its safety update and describing FDA questions as exactly what "you would expect." The securities action claims these assurances concealed growing regulatory risk.

November 5-6, 2025: Q3 Earnings Accelerate Pre-Launch Spending

The complaint recounts that Aquestive escalated its optimistic messaging. Management told investors:

• The FDA confirmed it was "aiming for an on-time review"
• No Advisory Committee meeting would be required, allegedly advancing the regulatory path
• Pre-launch hiring, marketing, supply chain, and payer engagement were all underway
• Management described the FDA process as having a familiar "cadence" and "feel" that "feels really good"

As detailed in the action, these statements induced investors to maintain or increase positions while the Company allegedly knew or recklessly disregarded deficiencies that threatened the January 31 deadline.

January 9, 2026: The Deficiency Letter Revealed

Aquestive disclosed that the FDA had identified deficiencies in the Anaphylm NDA that precluded labeling discussions and post-marketing commitments. The filing states that this disclosure effectively confirmed the drug would not be approved by the PDUFA date. Shares collapsed from $6.21 to $3.91.

The Warning Signs Multiplied

The securities action alleges that this timeline demonstrates a pattern: with each quarterly update, management intensified its commitment to the January 31 approval date and expanded commercial spending, even as the FDA's concerns regarding human factors allegedly remained unresolved.

"Timely disclosure of material developments is fundamental to fair and efficient markets. The chronology here raises important questions about whether shareholders received accurate updates as the regulatory picture evolved," stated Joseph E. Levi, Esq.

Submit your claim before the deadline  or contact Joseph E. Levi, Esq. at (888) SueWallSt.

Those wishing to serve as lead plaintiff must act by May 4, 2026.

CONTACT:
SueWallSt.
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@SueWallSt.com
Tel: (888) SueWallSt
Fax: (212) 363-7171

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SOURCE SueWallSt.com