Aquestive completes Anaphylm studies, keeps Q3 2026 NDA resubmission timeline

Aquestive Therapeutics reported on August 11, 2026 that during the second quarter it completed the human factors validation study and the pharmacokinetic study required to address the deficiencies identified in the Complete Response Letter issued by the FDA on January 30, 2026.¹ The human factors work evaluated a revised packaging design, with changes made to the pouch opening, instructions for use, and pouch and carton labeling.¹ The company said results showed significant improvement across each deficiency identified in the CRL.¹

On the PK study, Aquestive said preliminary data showed the study met its primary endpoints, with no administration errors in the self-administration arm and no serious adverse events or discontinuations.¹ The company reaffirmed guidance to resubmit the Anaphylm NDA in the third quarter of 2026¹ and noted the CRL had not raised chemistry, manufacturing, or controls issues, and had not questioned clinical data supporting comparability to autoinjectors.¹ It said it will ask for an expedited review upon resubmission, though it cannot guarantee any shortened timeline.¹

Outside the U.S., Aquestive said it still expects to file in Canada before the end of 2026 and in the European Union during the first quarter of 2027¹, with existing clinical data expected to support additional 2027 filings, including in the United Kingdom.¹

On AQST-108, the topical epinephrine gel, the company said the Phase 1 study in androgenic alopecia showed no safety concerns and supports continued development,¹ with the program expanding into other dermatologic indications including atopic dermatitis.¹

Financially, cash and cash equivalents stood at $98.5 million as of June 30, 2026,¹ and the company said full-year 2026 guidance remains unchanged.¹