NasdaqGM:AQSTPharmaceuticals
Aquestive Therapeutics (AQST) Is Down 39.4% After FDA Flags Deficiencies in Anaphylm Filing - What's Changed
Aquestive Therapeutics recently disclosed that the FDA has identified unspecified deficiencies in the New Drug Application for its orally delivered epinephrine film Anaphylm, pausing labeling discussions and potentially affecting the timing of any approval decision ahead of the scheduled 31 January 2026 PDUFA date.
At the same time, the company is pressing ahead with plans to seek approvals for Anaphylm in Canada, Europe, and the UK in 2026, signaling an effort to build a global,...