NEW YORK, NY / ACCESSWIRE / September 27, 2021 / Pomerantz LLP announces that a class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of its officers. The class action lawsuit was filed in the United States District Court for the Northern District of California, Oakland Division, and registered as 21-cv-06228. Plaintiff brings this federal securities class action lawsuit under Sections 10 (b) and 20 (a) of the Securities Exchange Act of 1934 and promulgated United States Securities and Exchange Commission Rule 10b-5. hereunder, 17 CFR § 240.10b-5, on behalf of a group consisting of all persons and entities, other than the Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and on July 19, 2021 inclusive (the “Claim Period”), and which have been damaged as a result (the “Group”).
If you are a shareholder who purchased or otherwise acquired Ardelyx securities during the Class Period, you have until September 28, 2021 to request the court to appoint you as the primary claimant. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
[Click here for information about joining the class action]
Ardelyx is a specialty biopharmaceutical company focused on the development of first-class drugs to improve the treatment of people with cardio-renal disease. This includes patients with chronic kidney disease (“CKD”) on dialysis with elevated serum phosphorus or hyperphosphatemia; and patients with CRF and / or patients with heart failure with high serum potassium or hyperkalaemia.
The complaint alleges that, throughout the litigation period, the defendants made materially false and misleading statements regarding tenapanor and the likelihood of its being approved by the United States Food and Drug Administration (“FDA”). The defendants owned, controlled and, therefore, knew (or had reason to know) that the data submitted in support of a new drug application (“NDP”) for tenapanor was insufficient in that it showed a lack of clinical relevance of the drug’s therapeutic effect, making it predictable (if not certain) that the FDA would not approve the drug.
In June 2020, the defendants submitted an NDA to the FDA for Ardelyx’s lead product candidate tenapanor, a drug believed to be first in its class for the control of serum phosphorus in adult patients with CKD on dialysis. . According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the intestine to inhibit the sodium-hydrogen exchanger 3, or NHE3,” causing “the tightening of epithelial cell junctions, thereby significantly reducing the paracellular uptake of phosphate, the major pathway for phosphate uptake. “If approved, tenapanor” would be the first treatment for the management of phosphate which blocks the uptake of phosphorus at the major pathway of uptake[,]”and” could greatly improve patient adherence and compliance with a single pill administered twice a day unlike current therapies where generally several pills are taken before each meal. “Thus, tenapanor (and its promise) has been widely touted by defendants and, as a result, extremely important to the valuation (and future success) of Ardelyx stocks.
The FDA accepted Ardelyx’s NDA in September 2020 and set the date for the Prescription Drug User Fee Act (“PDUFA”) as April 29, 2021.
The Company has repeatedly praised this development, highlighting the acceptance and review of the NDA by the FDA, supported by so-called “successful” Phase 3 studies, in each quarterly report filed thereafter and in the annual report. 2020 of the Company. Even when the FDA asked the Company to provide additional information on Ardelyx’s clinical data, which pushed the PDUFA date back by three months, the defendants continued to tout the results of the “positive” clinical trials. ‘Ardelyx, which they said showed “improvements” over current treatments, supported the “clinical safety and efficacy” of tenapanor and enhanced its “potential” as a “transformative” treatment. At no point have the defendants stated (let alone suggested) that there could be fatal issues with the drug, its clinical trial data, or both. Instead, the defendants simply asserted that the FDA’s request was simply because they needed help to “better understand the clinical data in light of tenapanor’s novel mechanism of action compared to approved therapies. “.
The defendants’ rosy tale, however, came to a halt after the market closed on July 19, 2021. At that time, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, stating that the administration had found gaps. this precluded any discussion of potential labeling and post-marketing requirements for tenapanor. Critically, the FDA has said it problems detected both in terms of size and clinical relevance the therapeutic effect of the drug.
Immediately, analysts lowered their price targets and lowered the company’s rating. Piper Sandler, for example, rated Ardelyx as neutral (down from an equivalent purchase valuation) and wrote: “We are struggling to see a way forward for Tenapanor.” Raymond James, another analyst, reset the company’s price target to $ 4.00 from $ 14.00 per share.
The Company’s share price also fell, falling $ 5.69 per share, or nearly 74%, in a single day, to close at $ 2.01 per share on July 20, 2021, before falling. still 4.2% at market close on July 21, 2021.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris and Tel Aviv, is recognized as one of the leading firms in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the Dean of the Class Actions Bar, Pomerantz was a pioneer in the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous multi-million dollar damages on behalf of the members of the group. See www.pomlaw.com.
THE SOURCE: Pomerantz srl
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