Ardelyx, Inc. Investors Lawsuit

Investigation

Continous Holding
August 6, 2020 to July 19, 2021

Proposed Claim
Securities Violation

Investigation regarding Ardelyx’s New Drug Application for tenapanor and subsequent FDA complete response letter (CRL) identifying deficiencies.

Main Event

Update Letter

07/19/2021

Company Statement

Ardelyx provides an update on the company’s New Drug Application (NDA) for tenapanor:
“[we] received a letter from the U.S. Food and Drug Administration (the “FDA”) on July 13, 2021, stating that, as part of its ongoing review of the company’s New Drug Application (“NDA”) for the control of serum phosphorus in adult patients with chronic kidney disease (“CKD”) on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close	Previous close	Price variation	Percentage variation
$2.01	$7.7	$-5.69	-73.9%

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Initial Lawsuit

Plaintiff brings this federal securities class action on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive.

Filing Date
07/30/2021
Class Period
08/06/2020 to 07/19/2021
Transgression
Securities Violation
Filing Firms
Scott+Scott Attorneys at Law LLP
Case Title
Strezsak v. Ardelyx Inc. et al
Docket Number
4:21-cv-05868
Court
California Northern District Court
Free File
Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:

Defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support the NDA was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug.