Aquestive Announces FDA Acceptance of Anaphylm NDA Resubmission, PDUFA Date Set for March 16, 2027

H.C. Wainwright reiterated a Buy rating and $10 price target for Aquestive Therapeutics (AQST) after the FDA accepted its drug candidate resubmission. AQST shares are down 15% this week but analysts see undervaluation. The company reported Q2 revenue of $13.82M, up 38% YoY, but a wider loss per share than expected. Cantor Fitzgerald also reiterated an Overweight rating with an $11 target.

Aquestive Therapeutics (AQST) announced the FDA accepted its resubmission for Anaphylm, a sublingual epinephrine film for severe allergic reactions. The FDA set a PDUFA goal date of March 16, 2027. The company addressed prior FDA concerns in the resubmission. If approved, Anaphylm could offer a needle-free treatment option. AQST stock closed at $4.61, up 1.30% in pre-market trading.

Aquestive Therapeutics (AQST) announced the FDA accepted its resubmission for Anaphylm, a treatment for Type I allergic reactions. The FDA set a PDUFA goal date of March 16, 2027. The resubmission follows positive study results addressing prior FDA concerns. If approved, Anaphylm would be the first oral rescue medication for severe allergic reactions.

Aquestive Therapeutics, Inc. (AQST) filed an SEC Form 8-K — Regulation FD Disclosure. Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027 • FDA accepted the resubmission as complete and classified it as a Class 2 response • Prescription Drug User Fee Act (PDUFA) goal action date set for March 16, 2027

Eton Pharmaceuticals (ETON) and Aquestive Therapeutics (AQST) signed an exclusive U.S. licensing agreement for LIBERVANT, a buccal film seizure rescue therapy. Eton gains commercialization rights, while Aquestive will manufacture. The U.S. seizure rescue market is estimated at over $450 million annually. LIBERVANT is expected to launch in April 2027, pending FDA approval. Both companies' stocks showed mixed trading activity.

Aquestive Therapeutics (AQST) shares rose in premarket trading after signing an exclusive license agreement with Eton Pharmaceuticals (ETON) for its anti-seizure drug, Libervant. Eton will obtain exclusive rights to the medication.