Aquestive Therapeutics Under Scrutiny: Investors Face Uncertainty After FDA Setback

It’s always a tough day when investors wake up to news that sends their portfolio into a tailspin. And for shareholders of Aquestive Therapeutics (NASDAQ: AQST), that’s precisely what happened recently. A prominent law firm, Faruqi & Faruqi, LLP, known for championing investor rights, has now stepped in, launching a thorough investigation into potential claims against Aquestive Therapeutics and some of its key officers.

The crux of the matter, you see, revolves around whether the company might have, perhaps inadvertently or otherwise, failed to disclose crucial information or even made statements that could be seen as misleading to the investing public. This kind of situation can be incredibly disheartening for anyone who’s put their hard-earned money into a company, trusting in its future prospects.

Specifically, the investigation hones in on a major setback: the U.S. Food and Drug Administration (FDA) issued what’s known as a Complete Response Letter (CRL) concerning Libervant. Now, Libervant is Aquestive’s oral film formulation of diazepam, intended to help manage those frightening seizure clusters. A CRL, in simple terms, isn’t an outright rejection, but it’s certainly not an approval. It essentially tells a company, "Not yet, you need to provide more data or address these specific concerns."

And what were those concerns? Well, the FDA pointed to a couple of key areas. Firstly, they found insufficient data from a "tendency to use" study. This is vital for understanding how patients might realistically use the medication in a real-world setting. Secondly, there was a noted absence of a weight-based dosing study within the target patient population. Both of these are pretty significant hurdles to clear when you're trying to get a new treatment approved.

The market’s reaction, as you might expect, was swift and brutal. Following the announcement of this FDA setback on February 25, 2020, Aquestive’s stock took a nosedive, plummeting by nearly 35%. Imagine the shock and dismay for those who had placed their trust and capital in Aquestive, only to see such a substantial portion of their investment vanish in a single day. It’s a painful blow, to say the least.

This is precisely where Faruqi & Faruqi comes into play. They’re looking to represent investors who’ve experienced significant financial losses due to these events. The firm’s investigation seeks to determine if there were indeed any violations of federal securities laws, essentially asking if the company and its leadership acted responsibly and transparently with their shareholders.

For any investors out there who are feeling the sting of these losses and believe they might have a claim, Faruqi & Faruqi is actively encouraging them to come forward. They’re offering a confidential consultation to discuss individual situations, explore legal options, and potentially join a class action lawsuit aimed at recovering damages. It’s a chance for those affected to seek some measure of justice and accountability.

Navigating the complexities of securities law can be daunting, but with experienced counsel, investors can understand their rights and pursue avenues for recourse when such unfortunate situations arise. It serves as a stark reminder of the inherent risks in the stock market, and the importance of corporate transparency.