Why Did AQST Stock Plunge 40% In Pre-Market Today?

• Anaphylm is Aquestive’s sublingual epinephrine film for allergic reactions.
• The Anaphylm application is supported by 11 clinical studies involving 411 subjects, the company said.
• Aquestive is working with the agency to better understand and address the issues ahead of the PDUFA date on January 31, it added.

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.

“As part of its ongoing review of the Company’s NDA for Anaphylm, the FDA notified us that it had identified deficiencies in the NDA that preclude discussion of labeling and post-marketing commitments at this time. Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns. The FDA stated that the notification does not reflect a final decision on the pending application and the FDA’s review remains ongoing,” said Dan Barber, President and Chief Executive Officer of Aquestive.

How Did Stocktwits Users React?

Despite the strong intraday decline, retail sentiment on Stocktwits for AQST turned 'extremely bullish' from 'bullish' a day earlier, amid 'extremely high' message volumes. 

Over the past year, the stock has gained 23%.

For updates and corrections, email newsroom[at]stocktwits[dot]com. 

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