Shares Slide with 5.68M Volume after FDA Flags Deficiencies in Allergy Drug Filing
FDA reviewers have identified deficiencies in Aquestive’s allergy drug application, prompting a session volume of 5.68 million shares—double its 2.79 million average. The regulatory setback drove the company’s stock sharply lower Friday, potentially delaying the product’s approval timeline and impacting revenue forecasts.
1. Aquestive Faces FDA Setback on Allergy Drug Application
Aquestive Therapeutics Inc. saw its shares trade sharply lower on Friday after the U.S. Food and Drug Administration identified deficiencies in the company’s new drug application for its experimental allergy therapy. Trading volume reached 5.68 million shares, more than double the stock’s 30-day average volume of 2.79 million, as investors grew concerned the review delay could push back a potential approval decision into late 2024. The FDA’s review letter flagged incomplete stability data and requested additional clinical pharmacology analyses, raising questions about the timeline for a resubmission. Management reiterated its commitment to addressing the agency’s comments promptly but acknowledged the need for extra time and resources, a development that may affect the company’s cash burn and capital allocation plans in the coming quarters.