On July 15, 2020, it was announced in a press release issued by Tricida that, on July 14, 2020, the company had received a notification from the U.S. Food and Drug Administration (“FDA”) which stated that, as part of its ongoing review of the company’s New Drug Application (“NDA”) for Tricida’s drug candidate veverimer (TRC101), “the FDA ha[d] 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.”
On July 16, 2020 Tricida’s stock price fell $10.56 per share on this news, or 40.31%, to close at $15.64 per share.
Then, on August 24, 2020, it was announced by Tricida that a Complete Response Letter (“CRL”) was received from the FDA for its NDA for veverimer on August 21, 2020. Tricida advised that, “[a]ccording to the CRL, the FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer” and “the applicability of the treatment effect to the U.S. population.” It was further advised by Tricida that the “FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit.”
On August 24, 2020, Tricida’s stock price fell $3.13 per share on this news, or 23.64%, to close at $10.11 per share.
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