This morning, Aquestive Therapeutics provided a pivotal regulatory update regarding its lead product candidate, Anaphylm™ Sublingual Film, a needle-free treatment for severe allergic reactions. On January 9, 2026, the company announced it had received a letter from the US Food and Drug Administration (FDA) indicating that the agency had identified “deficiencies” in the New Drug Application (NDA). These issues are currently preventing the initiation of labeling discussions or the finalization of post-marketing commitments, which are typically the final steps before a potential approval.
Despite the setback, the FDA confirmed that its review of the Anaphylm NDA remains active and that no final decision has been made on the drug’s approvability. The agency’s notification did not specify the exact nature of the deficiencies, but it clarified that the letter does not constitute a final regulatory action. The company remains focused on its Prescription Drug User Fee Act (PDUFA) target action date, currently set for January 31, 2026.
Dan Barber, President and Chief Executive Officer of Aquestive, addressed the development with a focus on cooperation and transparency. “As part of its ongoing review of the Company’s NDA for Anaphylm, the FDA notified us that it had identified deficiencies in the NDA that preclude discussion of labeling and post-marketing commitments at this time,” Barber stated. He added, “We remain committed to working closely with the FDA to address any outstanding items as we move toward the January 31, 2026, PDUFA goal date.”
While the domestic path faces new hurdles, Aquestive is aggressively pursuing international expansion for Anaphylm. The company reported significant progress in global markets, including ongoing regulatory activities in Canada, the European Union, and the United Kingdom. This strategy aims to provide a device-free, sublingual alternative to traditional epinephrine auto-injectors on a global scale, tapping into a significant unmet need for more portable and less invasive emergency allergy treatments.
Ultimately, the announcement highlights the volatility of the biotech regulatory landscape. While the “deficiencies” identified by the FDA introduce uncertainty, Aquestive’s leadership maintains a positive outlook on the transformative potential of their sublingual film technology. As the January PDUFA date approaches, the food allergy community will be watching closely to see how quickly the company can resolve the agency’s concerns and bring the first non-invasive epinephrine film to market.
