Aquestive Therapeutics reported that the FDA has identified deficiencies in the New Drug Application for Anaphylm, its lead naloxone product, triggering a procedural review that delayed the anticipated approval timeline. The company’s stock fell by 40% following the announcement. Management emphasized that the FDA’s comments relate primarily to manufacturing controls and packaging specifications rather than clinical efficacy or safety data. With approximately $120 million in cash on hand and a monthly burn rate of $5 million, Aquestive retains roughly two years of operational runway to address the agency’s feedback and resubmit the application without needing to raise additional capital immediately.

Over the past four weeks, AQST shares have declined 37%, pushing key momentum indicators into oversold territory. Wall Street analysts have collectively raised full-year earnings estimates by an average of 15% since the beginning of the quarter, reflecting growing confidence in the company’s broader product pipeline, including its oral film platform for central nervous system therapies. Chart-based investors note a bullish divergence on the relative strength index, suggesting that recent selling pressure may have been overdone and setting the stage for a potential trend reversal once the FDA feedback is resolved.