The company said the U.S. FDA identified deficiencies that prevent labeling discussions for a drug to treat allergic reactions.
Shares of Aquestive Therapeutics (AQST) plunged 40% in pre-market trading on Friday after the company announced that it received a letter from the U.S. Food and Drug Administration (FDA) identifying deficiencies that currently prevent labeling discussions on Anaphylm.
Anaphylm is Aquestive’s sublingual (under the tongue) epinephrine film for allergic reactions.
However, the FDA also confirmed its review of the New Drug Application (NDA) remains ongoing, and no final decision has been made.
Aquestive is working with the agency to better understand and address the issues ahead of the PDUFA (Prescription Drug User Fee Act) date on January 31, noting that delays in receiving details could impact the approval timeline. A PDUFA date is the FDA's target date to make a decision on a drug application.
The Anaphylm application is supported by 11 clinical studies involving 411 subjects, demonstrating pharmacokinetics comparable to epinephrine auto-injectors and a similar safety profile, Aquestive added.
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