Aquestive Therapeutics (AQST) has received a Complete Response Letter from the FDA for the New Drug Application seeking approval of Anaphylm Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more. In the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors validation study. The company plans to rapidly conduct a new HF validation study.
Aquestive Therapeutics said it will request a Type A meeting with the FDA to discuss the most efficient path forward for resubmission. Based on initial review of the CRL, the company estimates resubmission in third quarter of 2026. The company plans to request rapid review by the FDA.
Aquestive also plans to continue advancing its global expansion strategy for Anaphylm. The company received positive feedback from the European Medicines Agency that no further clinical trials are needed prior to regulatory approval submission. Aquestive expects to submit marketing authorization application in Europe as well as New Drug Submission in Canada in the second half of 2026. The company expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in the first quarter of 2026.
In pre-market trading on NasdaqGM, Aquestive shares are up 32 percent to $3.90.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.