SAN DIEGO & SAN FRANCISCO--(BUSINESS WIRE)--Shareholder rights law firm Robbins LLP is investigating Tricida, Inc. (NASDAQ: TCDA) to determine whether certain Tricida officers and directors violated the Securities Exchange Act of 1934 and breached their fiduciary duties to the Company. Tricida is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of non-absorbed therapies. Its lead drug candidate veverimer (TRC101) is intended to slow the progression of chronic kidney disease ("CKD") through the treatment of metabolic acidosis.
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Tricida, Inc. (TCDA) Misled Shareholders About the Viability of its Clinical Trial and Efficacy of its Lead Drug Candidate
According to a complaint filed against the Company, Tricida conducted a single Phase 3 study for veverimer and sought approval under the FDA's Accelerated Drug Application ("ADA") program. Based on the strength of these trial results, Tricida went public on June 28, 2018. The offering registration statement and its prospectus misrepresented material facts. Specifically, the prospectus informed investors that Tricida's "double blind, randomized, placebo-controlled” trial was conducted "at 47 sites in the United States and Europe," touted the success of the trial, and stated that "based on feedback from the FDA … [the] trial[] will provide sufficient evidence of clinical safety and efficacy to support the submission and review of an NDA for TRC101 pursuant to the [ADA]." For years, Tricida's executives touted the success of the trial and hid the truth from investors.
On February 25, 2021, Tricida finally informed investors that the FDA had rejected the New Drug Application for veverimer, and the FDA's Office of New Drugs denied Tricida's appeal. Specifically, the FDA concluded: (1) the "extent of serum bicarbonate increase observed in the [] trial is not reasonably likely to provide a discernible reduction in CKD progression;" (2) "the confirmatory trial, VALOR-CKD, is underpowered;" (3) the trial results were "strongly influenced by a single site;" and (4) "the majority of sites for the [] trial" were in Eastern Europe, "where differences in patient management … might affect the treatment response to veverimer" "raising a concern of the applicability to a U.S. patient population." The stock fell on this news, wiping out $93 million in market capitalization.
Tricida, Inc. (TCDA) shareholders have options. If you would like more information regarding your rights, please contact Lauren Levi at (800) 350-6003 or llevi@robbinsllp.com, or via our Shareholder Information Form.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
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