Aquestive Therapeutics Inc. (NASDAQ:AQST) experienced a pronounced decline in its stock price on Friday, falling by more than 40% amid trading volumes that were double the daily average. The session commenced with a volume of 5.68 million shares compared to the usual 2.79 million, signaling heightened market activity linked to recent regulatory developments.
The downward pressure on the stock was triggered by the announcement that the U.S. Food and Drug Administration (FDA) has identified certain deficiencies in the company’s New Drug Application (NDA) for Anaphylm, its polymer matrix-based epinephrine prodrug candidate designed for severe allergic reactions including anaphylaxis.
The FDA notification explicitly mentioned that these deficiencies currently prevent any substantive discussions regarding the drug’s labeling and post-marketing commitments. Although the FDA did not disclose the specific nature of these issues, Aquestive is actively engaging to understand and resolve them promptly.
Crucially, the FDA emphasized that the communication does not constitute a definitive decision about the application’s approval status. Instead, the review process remains active, and the agency's Feedback indicated that the standard review timeline continues despite the notified deficiencies.
Anaphylm stands out as a sublingual film drug formulation intended to offer an alternative to traditional epinephrine administration methods. Its compact dimensions — comparable in size to a postage stamp and weighing under one ounce — facilitate easy use without requiring water or swallowing, as the film begins to dissolve immediately upon oral contact.
Looking beyond the U.S. market, Aquestive has articulated strategic ambitions to expand Anaphylm's global footprint through regulatory submissions planned in Canada, Europe, and the United Kingdom, all targeted for 2026. The firm is positioning Anaphylm to capture a significant share in both domestic and international therapeutic markets for anaphylaxis treatment.
In response to the FDA’s feedback, Aquestive is maintaining active communication with the agency to clarify the deficiencies and to formulate necessary remedial actions. The company seeks to resolve outstanding issues well in advance of the Prescription Drug User Fee Act (PDUFA) action date, scheduled for January 31, 2026.
The FDA's clarification also indicated that it will not issue a Discipline Review Letter, though the possibility of additional information requests exists throughout the remainder of the review period. However, the absence of detailed disclosure on the nature of these deficiencies might contribute to delays in the drug's ultimate approval.
Financially, Aquestive concluded the fiscal year 2025 with a robust cash position of approximately $120 million in cash and cash equivalents. The management has expressed confidence that this liquidity is sufficient to sustain the company through the Anaphylm approval process and subsequent U.S. market launch, pending regulatory clearance. Concurrently, funds will support ongoing regulatory efforts in key international regions.
It is noteworthy that in September 2025, ARS Pharmaceuticals Inc. (NASDAQ:SPRY) submitted a petition urging the FDA to postpone approval of Anaphylm. The petition raised concerns surrounding safety profiles, dosing accuracy, and considerations for real-world application, introducing a layer of competitive and regulatory scrutiny to Aquestive's pathway.
The trading implications manifested swiftly, with Aquestive Therapeutics stock closing at $3.71 on Friday, reflecting a 40.18% decrease. Market observers continue to monitor these developments closely as the company navigates the complexities of regulatory compliance and competitive pressures.