TCDA - Tricida stops kidney disease study of veverimer due to administrative reasons

Tricida (NASDAQ:TCDA) said it is stopping its VALOR-CKD trial of veverimer for kidney disease early due to administrative reasons pursuant to a study protocol to allow for six months of financial runway after reporting top-line results, which is expected early in Q4 2022. "We have previously received feedback from the FDA on the administrative stop and believe that stopping the VALOR-CKD trial early will allow us to obtain interpretable data from the trial. We expect this data will allow us to evaluate how treatment with veverimer impacts slowing of CKD progression in patients with metabolic acidosis and CKD," said Tricida's President and CEO Gerrit Klaerner. In August 2020, the FDA rejected the company's application seeking approval of veverimer to treat metabolic acidosis in patients with chronic kidney disease (CKD). The U.S. drug regulator had cited the need of additional data beyond the TRCA-301 and TRCA-301E trials. Then the company met with the FDA

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Tricida stops kidney disease study of veverimer due to administrative reasons