Aquestive Therapeutics (AQST): Second Chance At Anaphylm Comes Into Focus

On August 11, Aquestive Therapeutics (NASDAQ:AQST) announced it had completed the necessary studies to resubmit its Anaphylm epinephrine film to the FDA in Q3 2026. The company had previously addressed the deficiencies raised in the January 30 Complete Response Letter (CRL) by conducting a human factors validation study and a pharmacokinetic study.

The FDA did not question the clinical data comparing Anaphylm to autoinjectors, narrowing the focus of the resubmission to the two issues the company had resolved. Aquestive expects to request an expedited review, but acknowledges no guarantee of a faster timeline. The company's manufacturing business is growing, with 48 million doses produced in the quarter, up from 37 million a year earlier.

Revenue climbed 38% to $13.8 million, and adjusted EBITDA loss narrowed to $5.2 million. However, the overall narrative remains one of uncertainty, as the FDA has previously rejected Anaphylm and the stock faces skepticism from 17.47% of its float. The company's net loss widened to $22.9 million, although this includes a significant one-time loss on debt extinguishment.

While Aquestive has taken steps to address the FDA's concerns, the resubmission remains the pivotal event that will determine the path forward for the company and its Anaphylm product.