NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of investors that purchased Tricida, Inc. (NASDAQ: TCDA) securities between September 4, 2019 and October 28, 2020 (the “Class Period”). Investors have until March 8, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Tricida is a pharmaceutical company that focuses on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally administered polymer designed as a potential treatment for metabolic acidosis in patients with CKD. Tricida has completed a Phase 3, double-blind, placebo-controlled trial of veverimer in patients with CKD and metabolic acidosis.
On September 4, 2019, Tricida announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) under the Accelerated Approval Program for approval of veverimer for the treatment of metabolic acidosis in patients with CKD.
On July 15, 2020, Tricida issued a press release announcing that, on July 14, 2020, the Company received a notification from the FDA, stating that as part of the FDA’s ongoing review of the Company’s NDA for veverimer, “the FDA has identified deficiencies that preclude discussion of labeling and post marketing requirements/commitments at this time.” Tricida stated that “[t]he notification does not specify the deficiencies identified by the FDA.”
On this news, Tricida’s stock price fell $10.56 per share, or 40.31%, to close at $15.64 per share on July 16, 2020.
Then, on October 29, 2020, Tricida announced an update on its End-of-Review Type A meeting with the FDA regarding the veverimer NDA, advising investors that the Company “now believes the FDA will also require evidence of veverimer’s effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial for approval under the Accelerated Approval Program and that the FDA is unlikely to rely solely on serum bicarbonate data for determination of efficacy.” Concurrently, Tricida disclosed that it “is significantly reducing its headcount from 152 to 59 people and will discuss its commitments with vendors and contract service providers to potentially provide additional financial flexibility.”
On this news, Tricida's stock price fell $3.90 per share, or 47.16%, to close at $4.37 per share on October 29, 2020.
The complaint, filed on January 6, 2021, alleges that throughout the Class Period defendants made materially false and misleading statements, and failed to disclose material adverse facts about the Company’s business, operational, and compliance policies. Specifically, defendants made false and/or misleading statements and failed to disclose to investors that: (i) Tricida’s NDA for veverimer was materially deficient; (ii) accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased Tricida securities during the Class Period and suffered a loss, are a long-term stockholder have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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