On July 15, 2020,Tricida, Inc. (NASDAQ: TCDA) stunned the market when it announced that it had received a notification from the U.S. Food and Drug Administration that, as part of the FDA’s review of Tricida’s New Drug Application for its drug candidate, veverimer, “the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.” On this news, Tricida’s stock price fell $10.56 per share, or over 40%.
Then on October 29, 2020,Tricida announced an update on its End-of-Review Type A meeting with the FDA concerning the veverimer New Drug Application, stating 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” trial for approval under the FDA’s 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 59people 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 another $3.90 per share, or over 47%, to close at just $4.37.
A lawsuit has been filed against Tricida and certain of its executives in the U.S. District Court for the Northern District of California. The lawsuit is captioned Pardi v. Tricida,Inc., et al., No. 3:21-cv-00076 (N.D. Cal.). The suit alleges that Tricida misled investors as to the viability of its veverimer NDA and that the NDA was materially deficient when presented.
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