It is alleged in this complaint that throughout the Class Period, Triceda made misleading and/or false statements and/or failed to disclose that: (i) Tricida’s NDA in regard to veverimer was materially deficient; (ii) accordingly, it was foreseeably likely that the NDA for veverimer would not be accepted by the FDA; and (iii) as a result, the Triceda’s public statements were materially misleading and false at all relevant times.
Tricida issued a press release on July 15, 2020 announcing that, on July 14, 2020, the it had received a notification from the FDA which stated that as part of the FDA’s ongoing review of the Company’s NDA for veverimer, “the FDA has 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.” Tricida’s stock price fell $10.56 per share on this news, or 40.31%, to close at $15.64 per share on July 16, 2020.
Then, on October 29, 2020, an update was announced by Triceda on its End-of-Review Type A meeting with the FDA in regard to the veverimer NDA, which advised investors that the Company “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 disclosed concurrently that it “is 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.” Tricida’s stock price fell $3.90 per share on this news, or 47.16%, to close at $4.37 per share on October 29, 2020.
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