Aquestive Therapeutics announced the FDA accepted its resubmitted New Drug Application for Anaphylm. The agency classified the sublingual film for severe allergic reactions as a Class 2 response. The FDA set a PDUFA goal date of March 16, 2027.
The treatment represents a potential first-of-its-kind oral rescue medication for anaphylaxis. The resubmission included positive results from new studies addressing issues raised in a previous Complete Response Letter.
Following the announcement, at least one analyst firm upgraded the stock to a Buy rating. A regulatory filing on October 16 disclosed CEO Daniel Barber sold 25,000 shares through a pre-planned transaction.