Kaskela Law LLC is investigating Tricida, Inc. (“Tricida” or the “Company”) (NASDAQ: TCDA) on behalf of the Company’s long-term investors. The investigation seeks to determine whether the members of Tricida’s board of directors violated the securities laws and/or breached their fiduciary duties in connection with alleged corporate misconduct.
Recently an amended securities fraud complaint was filed against Tricida on behalf of investors who purchased shares of the Company’s common stock between June 28, 2018 and February 25, 2021. According to the complaint, during that time period Tricida and certain of the Company’s senior executive officers made a series of false and/or misleading statements to investors concerning the Company’s attempt to gain approval from the United States Food and Drug Administration (“FDA”) for its lead investigational drug candidate, veverimer.
Veverimer is intended to slow the progression of chronic kidney disease (“CKD”) through the treatment of metabolic acidosis. In August 2019, Tricida submitted its New Drug Application (“NDA”) for veverimer to the FDA.
As detailed in the complaint, beginning in May 2020, Tricida began to receive indications from the FDA that there were issues with its NDA. Subsequently, Tricida disclosed to investors: (i) on July 15, 2020, that the FDA had notified it that the agency had “identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time”; (ii) on August 24, 2020, that it had received a Complete Response Letter (“CRL”) from the FDA explaining that Tricida’s Phase 3 trial alone could not demonstrate the efficacy of veverimer; (iii) on October 29, 2020, that the FDA had informed the Company that it was “unlikely to rely solely on serum bicarbonate data for determination of efficacy” and would “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 (iv) on February 25, 2021, that the FDA had denied the Company’s appeal of its NDA denial. Following these disclosures, shares of the Company’s stock declined from over $31.00 per share to below $10.00 per share.
Current Tricida stockholders who purchased or acquired shares of the Company’s stock prior to August 1, 2019 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by completing the form on this page, to receive additional information about this investigation and their legal rights and options.