According to the lawsuit, defendants throughout the Class Period made materially false and misleading statements regarding the Company’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with chronic kidney disease (“CKD”) on dialysis and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”). Specifically, the lawsuit alleges that defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support the New Drug Application (“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. When the true details entered the market, the lawsuit claims that investors suffered damages.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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