Ardelyx (ARDX) Stock Is Tumbling On FDA News

Ardelyx Inc (NASDAQ: ARDX) is taking a dive in the market this morning with the stock down more than 70% in the premarket as a result of sobering news from the FDA. Unfortunately, there’s a problem with the company’s recently submitted New Drug Application. 

Here’s what’s happening:

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ARDX Stock Tumbles On FDA Blues

In a press release issued early this morning, Ardelyx said it received a letter from the United States Food and Drug Administration on July 13, 2021. The letter said that the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. 

ARDX went on to say that it immediately requested a meeting to discuss the deficiencies and was notified by the FDA yesterday that the request for a meeting was denied. 

A Painful Reality With More Questions Than Answers

This is a big concern for Ardelyx, a company that has a relatively singular focus and lacks a robust pipeline. Not only was the drug rejected, a request for a meeting to discuss why and potentially address issues was denied. 

While the company said that the FDA has not provided specific details surrounding the deficiencies, it said a key issue was the size of the treatment effect and its clinical relevance. So, it’s back to the drawing board for ARDX with more questions than answers. 

Management Commentary

In a statement, Mike Raab, President and CEO at Ardelyx, had the following to offer:

This is an extremely disheartening and disappointing communication from the FDA, particularly following the weeks of label discussions that occurred in early April, the fact that our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA’s requests. We plan to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible.

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The Bottom Line

The bottom line here is simple. ARDX is in trouble if it can’t figure out the deficiencies that led to the rejection of the NDA. At the moment, it seems as though the company has little to go off of and is completely thrown off by the letter. However, without a meeting to shore things up and get an understanding as to why the drug was rejected, the company is up the figurative creek without a paddle and investors are responding, sending the stock plummeting. 

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