TCDA - Tricida falls after announcing appeal denied letter on trial for chronic kidney disease

Tricida (TCDA) has plunged ~24.6% in the post-market after announcing an appeal denied letter received from the Office of New Drugs (OND) of the FDA in response to its Formal Dispute Resolution Request ("FDRR") submitted in December 2020.The FDRR related to whether the size and durability of serum bicarbonate change seen in the TRCA-301/TRCA-301E trial could predict clinical benefit in the treatment of metabolic acidosis in patients with CKD.In August, citing the need for additional data beyond the TRCA-301 and TRCA-301E trials, the FDA rejected the approval for Tricida’s veverimer (TRC101) for metabolic acidosis in patients with CKD.The concerns addressed by the OND’s decision include the reliability of the data from the TRCA-301/TRCA-301E trial, due to issues such as outsize impact on data from a ‘single high-enrolling clinical site and the applicability of the trial results to the U.S. patient population.The OND has concluded that the extent of serum bicarbonate increase seen

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Tricida falls after announcing appeal denied letter on trial for chronic kidney disease