A recent legal filing alleges that senior leadership at a pharmaceutical company failed to properly oversee the development and regulatory submission process for its lead drug candidate, resulting in significant financial harm to the company and its shareholders. The complaint claims that these failures led to regulatory setbacks, misleading statements to investors, and unnecessary expenses.
The lawsuit was filed by Andre Wilson, a current shareholder acting on behalf of Aquestive Therapeutics, Inc., in the United States District Court for the District of New Jersey on April 15, 2026. The defendants named include members of the company’s Board of Directors and certain executive officers.
According to the complaint, Aquestive Therapeutics is a Delaware corporation focused on developing pharmaceutical products using proprietary film-based drug delivery technology. Its main product candidate is Anaphylm, described as an orally delivered epinephrine strip intended for emergency treatment of allergic reactions such as anaphylaxis. The standard treatment for anaphylaxis typically involves injectable auto-injectors like EpiPen or Auvi-Q. The company positioned Anaphylm as a non-device-based alternative due to patient reluctance toward injections.
Development efforts for Anaphylm began in 2022. After conducting clinical trials in 2023 and 2024, Aquestive submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in March 2025. Because sublingual administration of epinephrine had not previously been approved by the FDA for emergency use, regulators required a human factors validation (HFV) study to demonstrate that intended users could administer the medication safely under emergency conditions.
The HFV Study involved 166 participants but revealed several issues: one child participant could not open the product pouch; six participants tore the strip while opening it; four did not place it correctly under their tongues; and four removed it prematurely due to taste or burning sensation. These errors were flagged as potentially causing serious harm because delays or incorrect dosing during anaphylaxis can be fatal.
The complaint asserts that company directors and officers knew or should have known about these negative results before submitting them to regulators but failed to take remedial action such as redesigning packaging or revising instructions. Instead, they proceeded with submitting what plaintiff describes as a deficient HFV Study in support of FDA approval.
The document further alleges that oversight failures extended beyond internal processes to public communications with shareholders. Specifically, it cites an April 25, 2025 proxy statement which solicited votes for director re-election but did not disclose problems with Anaphylm’s regulatory submission or risks associated with its approval process. Subsequent press releases from June through November 2025 are also alleged to have contained materially misleading statements regarding progress toward FDA approval.
On January 9, 2026, Aquestive disclosed via press release that FDA-identified deficiencies in its NDA precluded further discussion about labeling or post-marketing commitments—an essential step toward approval by the January 31 deadline. Following this news, shares dropped more than 37 percent from $6.21 per share on January 8 to $3.91 per share on January 9.
Further details emerged on January 30 when the company announced receipt of a Complete Response Letter from FDA formally declining approval due primarily to issues identified in the HFV Study: difficulties opening packaging and incorrect film placement were cited as safety concerns during emergencies like anaphylaxis. In response, Aquestive stated it would modify packaging and labeling instructions and conduct another HFV Study before resubmitting its application later in 2026.
As outlined in court documents, these events triggered substantial financial consequences for Aquestive: exposure to class-action litigation costs; repeated regulatory fees; additional studies; delayed financing arrangements contingent upon product approval; continued interest payments on outstanding debt; and diversion of resources away from other business activities.
Plaintiff seeks relief including damages sustained by Aquestive due to alleged breaches of fiduciary duty under state law; violations of Section 14(a) of the Securities Exchange Act related to misleading proxy materials; aiding and abetting breaches by individual defendants; waste of corporate assets; and requests changes in corporate governance practices moving forward.
Attorneys representing plaintiff are not named explicitly within this portion of the filing provided. The case is identified as Case No. 3:26-cv-03982.
Source: 326cv03982_Wilson_v_Brown_MD_Complaint_District_New_Jersey.pdf
