The U.S. Food and Drug Administration sent a deficiency letter to Aquestive Therapeutics on January 9, 2026, stating that the company’s New Drug Application for Anaphylm, a sublingual epinephrine film, contains issues that prevent the agency from discussing labeling or post‑marketing commitments. The letter effectively stalls the company’s regulatory timeline and delays the anticipated launch of Anaphylm, which is central to its growth strategy.
The deficiency letter arrives just weeks before the PDUFA action date of January 31, 2026. If the FDA’s concerns are not addressed promptly, the company risks missing its critical approval deadline, jeopardizing the planned commercial rollout and the $75 million contingent financing from RTW Investments that is tied to FDA approval. As of December 31, 2025, Aquestive reported approximately $120 million in cash and cash equivalents, a reserve the company believes is sufficient to navigate the approval process and continue its global regulatory strategy, but the delay adds uncertainty for investors and could affect the company’s ability to secure the contingent financing.
Anaphylm is positioned as the first and only orally delivered epinephrine product, offering a needle‑free, portable alternative to traditional auto‑injectors. The U.S. anaphylaxis market is projected to reach $2 billion annually by 2031, and Anaphylm could capture 8‑12% of the auto‑injector market by 2033. Despite the U.S. setback, the company is progressing with regulatory submissions in Canada, Europe, and the United Kingdom in 2026, and the European Medicines Agency has indicated no additional clinical trials are required for the European submission. The company’s patents for Anaphylm extend exclusivity until at least 2037, providing a secure market position if approval is ultimately obtained.
CEO Dan Barber emphasized that the company is actively working to understand and resolve the FDA’s concerns. “We remain confident about Anaphylm’s potential to be the first and only FDA‑approved sublingual film,” Barber said. He added that the company is focused on addressing the deficiencies and maintaining momentum in its global regulatory strategy, underscoring confidence in the product’s innovation and market opportunity.
Investors have expressed concern over the regulatory setback, which has heightened uncertainty around the company’s financing and commercial rollout. The market reaction has been negative, reflecting the risk that the company may miss its PDUFA deadline and that the contingent $75 million financing could be jeopardized if FDA approval is delayed further.
The company’s next steps will involve submitting a detailed response to the FDA, addressing the identified deficiencies, and continuing its global regulatory submissions. If the FDA’s concerns are resolved in time for the January 31 action date, Anaphylm could still reach the market in 2026, but the company’s ability to secure the contingent financing and maintain its growth trajectory will depend on the speed and success of the FDA review process.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.