Philadelphia, Pennsylvania--(Newsfile Corp. - August 21, 2023) - A securities class action complaint alleges that Ardelyx Inc. (NASDAQ: ARDX), via certain of its officers, made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA, which led investors to suffer significant losses.
Specifically, it is alleged that on or about June 30, 2020, Ardelyx submitted a New Drug Application ("NDA") to the FDA to obtain approval to sell and market tenapanor for the treatment of hyperphosphatemia in adult CKD patients on dialysis. Because Defendants considered tenapanor their leading product candidate, the fate of Ardelyx's tenapanor NDA - i.e., whether the FDA would approve or reject it - was integral to the valuation and future success of Ardelyx securities.
Although Defendants repeatedly assured the market that the FDA's approval was all but guaranteed because the FDA had already seen some of the data and because the Company's meetings with the FDA were going well, in fact as early as March 2020 the FDA had raised substantial concerns that Ardelyx's clinical trial data had not shown a sufficiently quantifiable clinical benefit of administering tenapanor to treat hyperphosphatemia in adult CKD patients on dialysis. Then, on July 19, 2021, the Company announced that the FDA had rejected the tenapanor NDA for the exact reasons the FDA outlined in the March 2020 meeting.
Current Ardelyx shareholders who have held Ardelyx shares since on or before March 6, 2020, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them.
If you would like to learn more about this matter, you are encouraged to contact us at jgrabar@grabarlaw.com, visit https://grabarlaw.com/the-latest/ardelyx-shareholder-investigation/, or call 267-507-6085.
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Contact:
Joshua H. Grabar, Esq.
Grabar Law Office
One Liberty Place
1650 Market Street, Suite 3600
Philadelphia, PA 19103
Tel: 267-507-6085
Email: jgrabar@grabarlaw.com
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