Tricida, Inc

Tricida’s drug candidate, veverimer, is a polymer designed as a potential treatment for metabolic acidosis in patients with chronic kidney disease (“CKD”).  The Company 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 announced that it had received a notice from the FDA “identif[ying] deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.”  The Company stated that “[t]he notification does not specify the deficiencies identified by the FDA.”

On this news, the Company’s stock price fell $10.56, or 40.31%, to close at $15.64 per share on July 16, 2020, thereby injuring investors. 

Then, on October 29, 2020, following its End-of-Review Type A meeting with the FDA, Tricida announced that it “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.”  Tricida also disclosed that it was “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, the Company’s stock price fell $3.90, or 47.16%, to close at $4.37 per share on October 29, 2020, thereby injuring investors.

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Tricida's NDA for veverimer was materially deficient; (2) accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer; and (3) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.