Tricida, Inc. Class Action Lawsuit
- Company Name
- Tricida, Inc.
- Stock Symbol
- Class Period
- September 4, 2019 to October 28, 2020
- Northern District of California
The Tricida, Inc. class action lawsuit charges Tricida and certain of its executives with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers or acquirers of Tricida securities between September 4, 2019 and October 28, 2020, inclusive (the “Class Period”). The Tricida class action lawsuit was commenced on January 6, 2021 in the Northern District of California and is captioned Pardi v. Tricida, Inc., No. 21-cv-00076.
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 chronic kidney disease (“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.
The Tricida class action lawsuit alleges that, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose: (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, Tricida’s public statements were materially false and misleading at all relevant times.
On July 15, 2020, Tricida issued a press release announcing that, on July 14, 2020, Tricida received a notification from the FDA, stating that as part of the FDA’s ongoing review of Tricida’s NDA for veverimer, “the FDA has identified deficiencies that preclude discussion of labeling and postmarketing 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 more than 40%.
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 Tricida “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 an additional 47% – further damaging investors.
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