January 06, 2021 - An investor in shares of Tricida, Inc. (NASDAQ: TCDA) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by Tricida, Inc. in connection with certain allegedly false and misleading statements made between September 4, 2019 and October 28, 2020.

San Francisco, CA based Tricida, Inc., a pharmaceutical company, focuses on the development and commercialization of its drug candidate, TRC101, a non-absorbed, orally-administered polymer designed as a potential treatment for metabolic acidosis in patients with chronic kidney disease (CKD). Tricida, Inc. has completed a Phase 3, double-blind, placebo-controlled trial of veverimer in patients with CKD and metabolic acidosis.

On September 4, 2019, Tricida, Inc. 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, Inc. announced 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 postmarketing requirements/commitments at this time. Tricida stated that [t]he notification does not specify the deficiencies identified by the FDA.

Then, on October 29, 2020, Tricida, Inc. 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. Shares of Tricida, Inc. (NASDAQ: TCDA) declined from $42.85 per share in December 2019 to as low as $3.74 per share on October 29, 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Tricida, Inc. (NASDAQ: TCDA) common shares between September 4, 2019 and October 28, 2020, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between September 4, 2019 and October 28, 2020, the Defendants made false and/or misleading statements and failed to disclose to investors that Tricida's NDA for veverimer was materially deficient, that accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer, and that as a result, the Company's public statements were materially false and misleading at all relevant times.