TLDR
- AQST stock falls nearly 40% after FDA flags deficiencies in Anaphylm NDA.
- Aquestive shares tumble as FDA review of oral epinephrine drug hits hurdles.
- FDA identifies NDA issues; AQST stock drops sharply amid Anaphylm uncertainty.
- Aquestive (AQST) faces regulatory review delays, sending shares down 39.7%.
- Anaphylm NDA issues push AQST stock lower as FDA review remains ongoing.
Aquestive Therapeutics (AQST) stock fell sharply to $3.7450, down 39.69%, by 10:45 AM EST.
Aquestive Therapeutics, Inc., AQST
The drop comes after the FDA identified deficiencies in the company’s New Drug Application for Anaphylm. AQST shares opened lower as traders reacted to the unexpected regulatory update.
The FDA has not specified the exact deficiencies in the Anaphylm NDA, but review remains ongoing. Aquestive is working to understand the concerns and expects to resolve them promptly. The market responded immediately, driving AQST stock down nearly 40 percent.
Despite the stock decline, Aquestive maintains plans to advance Anaphylm toward U.S. and global approvals. The company is confident in the drug’s potential as the first sublingual epinephrine film. AQST continues to pursue regulatory submissions in multiple countries in 2026.
FDA Review and Regulatory Update
Aquestive is in contact with the FDA to address deficiencies in the Anaphylm NDA before the PDUFA action date. The FDA confirmed that its review remains active and no final decision has been made. AQST is prepared for possible information requests during the remaining review period.
The company has conducted 11 clinical studies for Anaphylm with 967 administrations across 411 subjects. Data show Anaphylm delivers a pharmacokinetic profile comparable to leading epinephrine auto-injectors. Safety results indicate that Anaphylm was generally well tolerated in single and repeat-dose trials.
Further delays in FDA communications could postpone the potential approval of Anaphylm. Aquestive is focused on responding quickly to ensure the NDA progresses without further disruption. The stock drop reflects immediate investor reaction to the regulatory uncertainty surrounding Anaphylm.
Global Expansion and Commercial Strategy
Aquestive is planning submissions in Canada, Europe, and the U.K. in 2026 for Anaphylm regulatory approval. The company expects Health Canada and the MHRA to review applications in early 2026. The European Medicines Agency has indicated no additional trials are needed for marketing authorization submissions.
Aquestive plans to hire a U.S. sales force after approval and continues pre-commercial preparation. The company is focused on expanding access to Anaphylm globally for severe allergy management. Aquestive Therapeutics, Inc. sees international approvals as a key growth opportunity.
The company highlights its cash position and recent equity raise as sufficient to execute its growth strategy. Global expansion is expected to increase adoption of Anaphylm once regulatory approvals are secured. Aquestive Therapeutics, Inc. aims to provide the first orally delivered epinephrine therapy worldwide.
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