FDA Accepts Aquestive Therapeutics' Anaphylm NDA Resubmission

Key Facts

1The FDA has accepted the New Drug Application (NDA) resubmission for Anaphylm (dibutepinephrine) sublingual film.

2The FDA assigned a PDUFA goal date of March 16, 2027, classifying the resubmission as a Class 2 response.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for Anaphylm (dibutepinephrine) sublingual film, a treatment for Type I allergic reactions including anaphylaxis. Aquestive Therapeutics stated that the agency assigned a PDUFA goal date of March 16, 2027, for its decision, classifying the resubmission as a Class 2 response.

The resubmission was submitted on September 16, 2026, following the company's announcement in August 2026 of positive results from pharmacokinetic and human factors studies designed to address previous regulatory feedback. Regarding market performance, AQST closed at $4.61 on October 14, 2026, having traded between a low of $4.57 and a high of $4.73 during that session.