FDA Sees Deficiencies in Aquestive Therapeutics Drug Application

By Nicholas G. Miller

Aquestive Therapeutics said the Food and Drug Administration identified deficiencies in its new drug application for Anaphylm, an orally administered treatment for severe allergic reactions.

Shares sank 49% to $3.18 in premarket trading.

The notification from the FDA did not specify the deficiencies but said they "preclude discussion of labeling and postmarketing commitments at this time," said Aquestive Chief Executive Dan Barber on Friday.

The Warren, N.J., pharmaceutical company said it is in contact with the FDA to gather further information about the identified deficiencies. "Further delays in communicating the specific deficiencies may lead to a delay in the potential approval of Anaphylm," the company said.

Aquestive said it began engagement with drug regulators regarding Anaphylm in Canada, Europe and the U.K. in 2025.

Write to Nicholas G. Miller at [e-mail].

(END) Dow Jones Newswires

01-09-26 0744ET