Aquestive Therapeutics Faces Legal Scrutiny After FDA Flags Deficiencies in Anaphylm Application

2026-01-10 companies

Atlanta, Friday, 9 January 2026.
Aquestive Therapeutics is under investigation for potential securities violations following a nearly 40% stock plunge on January 9, 2026. The sharp decline occurred after the FDA identified deficiencies in the application for Anaphylm, the company’s severe allergy treatment, effectively stalling labeling discussions. With the critical January 31 approval deadline looming, multiple law firms are now examining whether the company misled investors regarding the drug’s regulatory viability.

Regulatory Stumble Disrupts Approval Timeline

The catalyst for the sudden market turmoil was a disclosure made by Aquestive Therapeutics on January 9, 2026, revealing that the U.S. Food and Drug Administration (FDA) had flagged issues with the company’s New Drug Application (NDA) for Anaphylm (epinephrine) Sublingual Film [1][2]. While the FDA confirmed that its review of the application is ongoing and no final decision has been rendered, the agency explicitly stated that identified deficiencies “preclude discussion of labeling and post-marketing commitments” at this time [2]. In the pharmaceutical regulatory process, the commencement of labeling discussions is typically viewed as a positive signal that a drug is nearing approval; conversely, a halt in these discussions often indicates significant hurdles [2]. This setback is particularly acute given the proximity of the Prescription Drug User Fee Act (PDUFA) action date, which is scheduled for January 31, 2026 [2][7].

Market Reaction and Investor Fallout

The market’s response to the regulatory uncertainty was immediate and severe. Following the news, shares of Aquestive Therapeutics (NASDAQ: AQST) plunged approximately 40% during intraday trading on January 9, 2026 [4][7]. This sharp devaluation reflects heightened investor anxiety that the Anaphylm NDA may not secure approval by the late-January target, potentially delaying the commercialization of the company’s treatment for severe allergic reactions and anaphylaxis [1][7]. The volatility has attracted the attention of the legal community, with firms such as Block & Leviton noting that the stock drop has caused significant losses for shareholders [4]. The sudden erosion of shareholder value has shifted the narrative from an anticipated product launch to a defensive posture regarding regulatory compliance and disclosure [4][5].

Investigations Mount Over Potential Disclosure Failures

In the wake of the stock collapse, Aquestive is now facing a wave of scrutiny from securities litigation firms. Holzer & Holzer, LLC, Faruqi & Faruqi, LLP, and Block & Leviton have all announced investigations to determine if the company and its leadership violated federal securities laws [1][4][5]. The core of these inquiries revolves around whether Aquestive’s officers or directors made misleading statements or failed to disclose material adverse information regarding the Anaphylm application prior to the FDA’s notice [1]. Specifically, investigators are examining if the company painted an overly optimistic picture of the drug’s regulatory prospects, thereby exposing investors to unquantified risks [1][5]. These investigations are often the first step toward shareholder class action litigation, aimed at recovering funds for investors who purchased stock based on what may prove to be incomplete or inaccurate representations [1][3].

Company Stance and Financial Outlook

Despite the mounting legal and regulatory pressure, Aquestive maintains that the path forward is not yet closed. Dan Barber, the company’s President and Chief Executive Officer, stated that the FDA notified them of the deficiencies as part of the ongoing review process, emphasizing that the agency has not yet issued a final decision [2]. From a liquidity perspective, the company reported having approximately $120 million in unaudited cash and cash equivalents as of December 31, 2025, providing a financial buffer as it navigates this period of uncertainty [2]. Looking beyond the immediate U.S. challenges, Aquestive has outlined a global strategy for 2026, with plans to submit regulatory applications in Canada, Europe, and the United Kingdom [2]. However, the immediate priority remains addressing the FDA’s concerns in an attempt to salvage the current NDA before the January 31 deadline [2].

Sources

Securities Litigation Pharmaceuticals