FDA Accepts Anaphylm NDA Resubmission, Sets March 16, 2027 Decision Date
AQST sits 56% above its 52-week low of $2.93.
Summary
The FDA accepted Aquestive's Anaphylm NDA resubmission as complete, classified it as a Class 2 response, and set a Class 2 PDUFA goal date of March 16, 2027. This is the expected next step after the September 16 resubmission, which followed the January 30 Complete Response Letter and the August human factors and PK data that addressed the FDA's concerns. Anaphylm, a sublingual epinephrine film, would be the first oral rescue medication for severe allergic reactions if approved. The roughly five-month review window removes near-term regulatory uncertainty and shifts the binary event to March 2027. Aquestive also remains on track to file a Canadian New Drug Submission in Q4 2026. The company's $98.5M cash position and contingent funding arrangements, disclosed in its September investor presentation, are the key backdrop for funding commercial launch preparations ahead of the decision.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The FDA classified the Anaphylm NDA resubmission as a Class 2 response, and Aquestive remains on track to file a Canadian New Drug Submission in Q4 2026.
At the time of this announcement, AQST was trading at $4.58 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $578.6M. The 52-week trading range was $2.93 to $7.55. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.