On August 11, Aquestive Therapeutics (NASDAQ:AQST) reported second-quarter 2026 results and said it remains on track to resubmit its Anaphylm epinephrine film to the FDA in the third quarter of 2026. That single sentence carries the whole story here. A company living and dying by one product candidate just cleared the studies standing between it and a second shot at approval, and the numbers underneath that news show a business trying to fund the wait.
Studies Clear, Clock Resets
Aquestive spent the second quarter closing out the deficiencies from the Complete Response Letter the FDA issued on January 30. It completed a human factors validation study testing a revised package, with a reworked pouch opening and updated labeling, and the results showed meaningful improvement on every issue the FDA had flagged. It also finished a pharmacokinetic study that met its primary endpoints, with no administration errors in the self-administration arm and no serious adverse events.
Importantly, the original CRL never raised chemistry, manufacturing, or controls concerns, and the FDA did not question the clinical data comparing Anaphylm to autoinjectors. That narrows this resubmission to the two issues the company says it just fixed. Aquestive plans to ask for an expedited review, though it is careful to note no faster timeline is guaranteed. Behind Anaphylm, the company is also widening its epinephrine prodrug platform, with a completed Phase 1 study in androgenic alopecia showing no safety concerns and an expansion into atopic dermatitis, a condition affecting roughly 7% to 10% of US adults.
The manufacturing business, meanwhile, is quietly picking up steam. Aquestive made about 48 million doses in the quarter, up from 37 million a year earlier, supplying products like Indivior’s Suboxone film and Cosette’s Sympazan. Total revenue climbed 38% to $13.8 million from $10.0 million, and the adjusted EBITDA loss narrowed to $5.2 million from $9.3 million. Cash sat at $98.5 million as of June 30, giving the company runway while it waits on the FDA.
Costs Are Climbing With The Ambition
The quarter’s bottom line tells a rougher story. Net loss widened to $22.9 million, or $0.18 per share, from $13.5 million, or $0.14 per share, a year ago. Most of that swing came from an $11.7 million one-time loss on extinguishing its 13.5% Notes; strip that out and the loss actually shrank to $11.2 million. Selling, general and administrative expenses still rose to $14.1 million from $12.7 million, driven by $2.1 million in higher legal fees and $1.4 million in severance costs tied to share-based compensation acceleration.
That combination of rising legal and personnel costs alongside a major debt payoff suggests a company still spending to get somewhere, not one that has arrived. And Anaphylm remains unapproved. This is a company that already absorbed one rejection, and while the flagged issues appear addressed, the FDA still has to agree before any of the commercial buildup matters. Libervant, the company’s other approved product, also stays boxed in until an exclusivity period tied to a rival drug expires in January 2027.
What The Market Is Pricing In
Hedge fund ownership slipped slightly, from 25 to 24 funds, a modest pullback rather than a stampede. Short interest sits at 17.47% of float, a heavy load that points to real organized skepticism about whether Anaphylm clears the FDA this time. That combination suggests that the market is waiting for the resubmission before taking a side.
A Story Still Waiting On One Answer
Aquestive has done what it said it would do: fix the studies, hold the cash, keep the manufacturing lines running. What it has not done yet is get Anaphylm approved. For the bulls, the case rests on a CRL that never touched manufacturing or clinical data, plus a royalty and manufacturing business that is already growing on its own. For the bears, a widening net loss and 17.47% of the float betting against the stock are reminders that the FDA has said no to this product once already. The third quarter resubmission is the event that will finally settle which side was reading it right.
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