TCDA - Tricida slumps 46% on FDA feedback on veverimer proposal; launches cost-cutting initiatives

Tricida (TCDA) plummets 46% after announcing an update on its End-of-Review Type A meeting with the FDA. This meeting followed a Complete Response Letter ((CRL)) received by the company in August 2020, for the veverimer NDA that was under FDA review through the Accelerated Approval Program. The company included a proposal to conduct an interim analysis of serum bicarbonate data from VALOR-CKD in ~500 patients treated for 12 months for purposes of confirming the treatment effect of veverimer observed in the TRCA-301/301E trials and its applicability, in its Type A meeting.If accepted, Tricida believed this proposal would allow resubmission of the NDA for veverimer within a matter of months.Based on feedback, the company now believes the FDA will also require evidence of veverimer’s effect on CKD progression from a near-term interim analysis and that the Agency will not rely solely on serum bicarbonate data for determination of efficacy.Based on the primary endpoint,

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Tricida slumps 46% on FDA feedback on veverimer proposal; launches cost-cutting initiatives