TCDA - Tricida revises VALOR-CKD trial protocol updates patent protection shares down 14%

Tricida (TCDA) drops 14% after-hours after announcing key updates on veverimer’s development program, regulatory status and patent protection. The company has revised the protocol for its VALOR-CKD outcome trial. The trial protocol previously had an adaptive design and included an unblinded interim analysis for sample size re-estimation.The revised protocol has a group sequential design, no interim analysis for sample size adjustment, and unblinded interim analyses for early stopping for efficacy after 150 primary endpoint events (anticipated in H2 2021) and 250 primary endpoint events (anticipated in mid-2022) have accrued.The interim analyses will be conducted by an independent Interim Analysis Committee, and the trial will remain blinded unless it is stopped early for efficacy. If successful, Tricida intends for it to serve as the confirmatory trial for accelerated approval or form the basis for traditional approval of veverimer. A Formal Dispute Resolution Request ((FDRR)) has been submitted to the FDA to seek clarity

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Tricida revises VALOR-CKD trial protocol, updates patent protection, shares down 14%