Aquestive Therapeutics AQST plummets 37.34% as FDA flags NDA deficiencies, stalls approval

The share price fell to its lowest level since the beginning of this month, with an intraday decline of 42.35% on 13 January. Aquestive Therapeutics (AQST) has seen its stock drop 37.34% over three consecutive sessions, marking its steepest selloff in months.

The sharp decline follows the U.S. Food and Drug Administration’s (FDA) identification of unspecified deficiencies in Aquestive’s New Drug Application (NDA) for Anaphylm, its orally administered epinephrine film. The regulatory feedback has stalled labeling discussions and delayed the FDA’s approval decision beyond the 31 January 2026 PDUFA date. Anaphylm, a first-of-its-kind non-injectable alternative to epinephrine auto-injectors, represents Aquestive’s core growth driver, and the setback has intensified uncertainty over its commercialization timeline. The company’s financial projections, including $125.9 million in revenue and $29.2 million in earnings by 2028, are now at risk, as U.S. market access remains critical to its viability.

Investor sentiment has turned sharply bearish, with AQST shares trading at a 163% discount to a $10.30 fair value estimate based on growth assumptions. The stock’s volatility reflects the market’s sensitivity to regulatory outcomes, as Aquestive’s current loss-making status and limited diversification amplify exposure to delays. While the company plans to pursue approvals for Anaphylm in Canada, Europe, and the UK in 2026, these efforts remain contingent on resolving the FDA’s concerns. Analysts remain divided on the stock’s potential, with price targets ranging from $9.13 to $22.44, underscoring the high-stakes nature of the regulatory review. The coming months will determine whether Aquestive can address the deficiencies and unlock Anaphylm’s market potential, or face further erosion of investor confidence.