Aquestive Therapeutics (AQST) called Anaphylm a breakthrough and told investors approval was on track. The company also signaled the allergy treatment was moving toward a 2026 launch. But according to the lawsuit, material issues affecting the FDA review were not disclosed.
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Investors are scrutinizing Aquestive Therapeutics after a federal lawsuit alleges the company misled shareholders about its flagship drug’s path to regulatory approval, triggering a sharp single-day stock collapse.
A securities lawsuit filed in the U.S. District Court for the District of New Jersey alleges that Aquestive Therapeutics, Inc. (NASDAQ: AQST) and its Chief Executive Officer made materially false and misleading statements to investors about the anticipated FDA approval of Anaphylm, a sublingual film epinephrine treatment. The complaint alleges that the company concealed or minimized material deficiencies affecting the NDA, which were later identified as human factors-related issues, while repeatedly assuring investors that approval by the January 31, 2026, PDUFA date was on track. On January 9, 2026, Aquestive disclosed that the FDA had identified unspecified deficiencies in its NDA that precluded labeling discussions, causing the stock to fall from $6.21 per share to $3.91 per share in a single trading session, a decline of more than 37%. The proposed class period runs from June 16, 2025, through January 8, 2026.
If you purchased Aquestive Therapeutics stock during the class period, you may wish to learn more about your potential legal rights.
What Aquestive Therapeutics Does and Why Anaphylm Mattered
Aquestive Therapeutics is a pharmaceutical company focused on treatments for anaphylaxis and epilepsy. The company describes its mission as advancing medicines through innovative science and drug delivery technologies. Its principal executive offices are located in Warren, New Jersey, and its common stock traded on the Nasdaq Global Select Market under the ticker symbol AQST during the relevant period.
Anaphylm, the drug at the center of the lawsuit, is a sublingual film formulation of dibutepinephrine designed to treat severe allergic reactions, including anaphylaxis. The company positioned Anaphylm as potentially the first and only device-free, orally delivered epinephrine treatment, describing it as thinner than a credit card and requiring no special storage. Regulatory approval of Anaphylm was widely described by company leadership as a key milestone for the company’s near-term commercial prospects.
What the Lawsuit Alleges Aquestive Got Wrong
The lawsuit alleges that throughout the class period, Aquestive and its CEO made repeated public statements expressing confidence that the company’s NDA for Anaphylm was on track for FDA approval by the January 31, 2026, PDUFA date, while allegedly concealing or minimizing known deficiencies related to the human factors aspects of the product. Specifically, the complaint alleges the defendants failed to disclose issues concerning the packaging, administration, use, and labeling of the sublingual film that the FDA ultimately cited as deficiencies precluding approval-related discussions. According to the complaint, these omissions caused investors to purchase Aquestive shares at artificially inflated prices.
The complaint further alleges that the FDA’s eventual Complete Response Letter, issued on January 30, 2026, cited deficiencies specifically in Aquestive’s human factors validation study, including instances of difficulty opening the pouch and incorrect film placement, problems the FDA stated could cause significant safety issues in the setting of anaphylaxis. Plaintiffs allege that Aquestive was aware of these human factors issues but failed to adequately communicate their significance or their potential impact on the approval timeline.
If you have been following this case, you can stay informed by tracking developments as the litigation proceeds.
What Aquestive’s Leadership Said During the Class Period
From June 2025 through early November 2025, CEO Daniel Barber made a series of public statements indicating that Anaphylm’s regulatory review was progressing without issue. On August 12, 2025, during a quarterly earnings call, Barber stated that the company was on track across all important elements of Anaphylm, including its FDA review process, and confirmed the January 31, 2026, PDUFA action date remained in effect. During the same call, when asked whether there had been any substantial data requests from the FDA beyond routine exchanges, Barber indicated there was nothing he would describe as a major data set beyond the standard 120-day safety update.
On November 6, 2025, Barber stated that the company was fully positioned for a first-quarter 2026 launch if Anaphylm received FDA approval, describing commercial preparations as complete and simply stating, “we are ready to go.” He also addressed FDA-related uncertainty during that call, stating that the review group had remained the same and that the company believed it was in good shape, even as broader leadership changes at the agency were occurring. The complaint characterizes these statements as materially false and misleading because they did not disclose the significance of the human factors concerns that would later form the basis of the FDA’s deficiency letter.
How the Alleged Truth Came to Light
On January 9, 2026, Aquestive issued a press release disclosing that it had received a letter from the FDA identifying unspecified deficiencies in its Anaphylm NDA that precluded discussion of labeling and post-marketing commitments. The company acknowledged that the deficiencies had not yet been specified and stated it was working to understand and resolve the FDA’s concerns. That day, shares of Aquestive fell from a closing price of $6.21 per share on January 8, 2026, to $3.91 per share, a single-session decline of more than 37%.
The full scope of the FDA’s concerns became clearer on February 2, 2026, when Aquestive disclosed that the agency had issued a Complete Response Letter on January 30, 2026. The CRL identified deficiencies in Aquestive’s human factors validation study, citing instances of difficulty opening the product’s pouch, incorrect film placement, potential tolerability issues, including burning and taste sensations, and concerns that these issues could lead to unsafe use of the product during an anaphylactic emergency. The company disclosed that resubmission was estimated for the third quarter of 2026, contingent on completing new human factors and pharmacokinetics studies.
Why This Lawsuit May Be Relevant to Aquestive Shareholders
Investors who purchased Aquestive stock during the June 16, 2025, through January 8, 2026, class period and held shares at the time of the January 9, 2026, disclosure may have sustained losses as a result of the alleged price correction. The complaint alleges that the stock’s artificial inflation was tied to management’s repeated statements that Anaphylm remained on track for approval by the January 31, 2026, PDUFA date, despite allegedly undisclosed human-factors-related deficiencies affecting the NDA. The abrupt disclosure of FDA deficiencies and the eventual CRL allegedly revealed a gap between what investors had been told and the NDA’s actual regulatory status.
The complaint notes that multiple analyst firms, including Cantor and Oppenheimer, lowered their price targets and flagged the elevated risk of a CRL following the January 9 disclosure. Analysts reportedly described the FDA’s communication as a significant setback and noted that similar letters had preceded 12- to 15-month approval delays in comparable cases.
The Legal Framework Underlying the Claims
The complaint asserts two counts under federal securities law. Count I alleges violations of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, claiming that Aquestive and its CEO engaged in a scheme to defraud investors by making materially false and misleading statements and omissions about the Anaphylm NDA approval timeline. Count II asserts a claim against CEO Daniel Barber under Section 20(a) of the Exchange Act as a controlling person, alleging that by virtue of his senior management position, he had the power to direct and did direct the company’s allegedly unlawful conduct.
The plaintiff seeks compensatory damages, pre- and post-judgment interest, attorneys’ fees, and other relief on behalf of all class members. If you purchased Aquestive Therapeutics stock during the class period, you may wish to consult with an attorney to understand your rights.
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